DDrare: Database of Drug Development for Rare Diseases

299. 嚢胞性線維症
［臨床試験数：1,592，薬物数：1,539（DrugBank：255），標的遺伝子数：81，標的パスウェイ数：162］

Searched query = "Cystic fibrosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 0.12% saline; 0.9% Isotonic Saline (IS); 0.9% Isotonic Saline (IS), 4mL; 0.9% normal saline (control); 0.9% w/v sodium chloride solution; 033841; 1,5 (Butylimino)-1,5-dideoxy-D-glucitol; 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[1-piperazinyl]-3-quinoline carboxylic acid; 100 mg ELX /50 mg TEZ /75 mg IVA FDC; 100 mg ELX/50 mg TEZ /75 mg IVA FDC; 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination; 100 mg TEZ/150 mg IVA FDC; 100 mg VX-445/50 mg TEZ /75 mg IVA FDC; 100 mg/m2 dose; 100-mg ELX (VX-445) / 50-mg TEZ / 75-mg IVA FDC; 100-mg ELX (VX-455) / 50-mg TEZ / 75-mg IVA FDC; 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC; 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC; 100-mg VX-445 /50-mg TEZ/75-mg; 100-mg VX-445/50-mg TEZ/75-mg IVA FDC; 100mg VX-445/50mg TEZ /75mg IVA FDC; 150-mg IVACAFTOR; 150mg IVACAFTOR; 2% Chlorhexidine solution wipes; 2,3-dihydroxybutanedioic acid; 2-aminoethanethiol; 200 mg/m2 dose; 25-Hydroxyvitamin D3; 2622U90 Duramycin; 291844; 4% chlorhexidine gluconate liquid skin cleanser; 4-phenylbutyrate; 4.2% NaCl/Inhalation solution; 4.2% NaCl/inhalation solution; 5-methyltetrahydrofolate and vitamin B12; 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination; 5000 IU of cholecalciferol; 552-02; 6% Hypertonic Saline (HS), 4mL; 7% Hypertonic Saline (HS); 7% NaCl; 7% saline; A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP); AAC Hexal; ABBV-2222; ABBV-3067; ABELCET; ACC; ACC600Tabs; ACETYLCYSTEINE; ACETYLCYSTEINE SODIUM; AER002; AIR DNase; AIR DNase™; ALTU-135; ALTUS-135; ALX-009; AMIKACIN SULFATE; AMILASA; AMITRIPTYLINE; AMOXICILLIN; AMYLASE; ANAKINRA; AP; AP-PA02; API; ARD-3150; ARIKACE™; ARO-ENaC; ATORVASTATIN; AZD1236; AZD5634; AZD5634 for infusion; AZD5634 for inhalation; AZD7986; AZD9668; AZITHROMYCIN; AZITHROMYCIN DIHYDRATE; AZLI; AZLI 75 mg three times a day (TID); AZLI 75 mg three times daily (TID); AZLI 75 mg two times a day (BID)/ three times a day (TID); AZLI 75 mg two times a day (BID)/three times a day (TID); AZTREONAM; AZTREONAM LYSINE; Abelcet; Acebilustat; Acetate; Acetylcysteine; Active Treatment Group 7% Hypertonic Saline; Actrapid 100 IU/ml, Solution for injection in a vial; Actrapid Penfill 100UI/ml; Acute Antioxidant; Adempas; Adempas 0.125 mg; Adempas 0.5 mg; Adempas 1.0 mg; Adempas 2.0 mg; Adeno-associated virus-CFTR vector; Advagraf prolonged-release hard capsules; AeroVanc; Aeroquin; Aerosolized, human, plasma-derived Alpha-1 Antitrypsin; Aerosoltherapy; Air; Ajulemic acid; Alanine; Albuterol; Albuterol inhaler.; Alendronate; Alendronate sodium; Alginate; Alginate oligosaccharide; Allo-hMSCs; Alpha-1 HC 100 mg; Alpha-1 HC 200 mg; Alpha1-Proteinase Inhibitor (Human); Alpha1-proteinase Inhibitor; Amikacin; Amikacin Sulfate; Amikacin nebulization; Amikacin sulfate; Amikacina; Amikacina liposomal (Arikace?); Amikacine; Amikacine nebulization; Amikin, amiklin, amicacin, BB-K8, Biklin, Fabianol, Kaminax, Mikavir, Novamin, Pierami; Amikin®, amiklin, amicacin, BB-K8, Biklin®, Fabianol®, Kaminax, Mikavir, Novamin®, Pierami; Amiloride; Amiloride HCl; Amiloride Solution for Inhalation; Amitriptylin; Amitriptylin-CT; Amitriptylin-ct Tabletten; Amitriptyline; Amoxicillin; Amoxicillin and Clavulanic acid; Amphotericin; Amphotericin B; Amylase; Anakinra; Andecaliximab; Anti-pseudomonas IgY gargle; Anti-reflux pharmacotherapy; Antibiotic; Antioxidant Cocktail; AquADEK; AquADEKs-2; Arginine; Aridol; Aridol or Osmohale; Arikayce; Arikayce™; Arikayce™ 140 mg; Arikayce™ 560 mg; Arikayce™ 70 mg; Ataluren; Ataluren (PTC124®); Atorvastatin; Augmentin; Aurexis; Aurexis® (tefibazumab); Avian polyclonal IgY antibody against PA; Avibactam; Azithromycin; Azithromycin 250 mg tablets; Azithromycin 500 mg film-coated tablet; Aztreonam; Aztreonam Lysine for Inhalation; Aztreonam for Inhalation (AI); Aztreonam for Inhalation Solution; Aztreonam for Inhalation Solution (AZLI); Aztreonam lysine; Aztreonam lysine for inhalation; Aztreonam solución para inhalación; Aztreonan lysine; BAL; BAY 85-8501; BAY q 3939; BAY63-2521; BAY85-8501; BAYQ3939; BAYq3939; BH4; BH4 20mg; BH4 5mg; BI 1265162; BI 1265162 10 µg; BI 1265162 100 µg; BI 1265162 25 µg; BI 1265162 50 µg; BI 1323495; BI 443651; BIIL 283 BS (Amelubent); BIIL 284 BS, high dose; BIIL 284 BS, high dose, adult patients; BIIL 284 BS, high dose, pediatric patients; BIIL 284 BS, low dose; BIIL 284 BS, low dose, adult patients; BIIL 284 BS, low dose, pediatric patients; BIIL 284 BS, medium dose, adult patients; BIIL 284 BS, medium dose, pediatric patients; BLF; BRAMITOB*NEBUL 28F 300MG/4ML; BRAMITOB*NEBUL 56F 300MG/4ML; Bactrim; Balance; Behavioral: Aerobic exercise; Behavioral: Balance exercise; Behavioral: Environmental Decontamination; Behavioral: Exercise; Behavioral: Flexibility and postural exercise; Behavioral: Resistance exercise; Behavioral: Unsupervised exercise; Beta-Adrenergic cocktail; Bethkis; Biaxin ( clarithromycin); Biklin; Bio-25 probiotic; Bisphosphonate treatment; Blood sample; Blood test; Boost VHC; Boots High Strength Garlic Odour Controlled; Bramitob; Bramitob 300mg/4ml Nebuliser Solution; Bramitob® administered by PARI LC® PLUS nebulizer; Bramitob® administered by PARI eFlow® rapid electronic nebulizer; Brensocatib; Brensocatib 10 mg; Brensocatib 25 mg; Broccoli; Broccoli sprouts; Bronchitol; Bucelipase alfa; Budesonide; Budesonide-formoterol single inhaler; Burlulipase; CAYSTON aztreonam 75 mg powder and solvent for nebuliser solution; CB-280; CEFALEXIN; CEFTAZIDIME; CEFTAZIDIME PENTAHYDRATE; CEFUROXIME; CF patients with a G551D mutation and treated with Ivacaftor; CFTR Modulators; CFTR potentiator; CHF 6333; CHF6333 (Part 1 - SAD); CHF6333 (Part 2 - MAD); CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE; CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE; CIPROXIN*6CPR RIV 500MG; CLARITHROMYCIN; CLAVULANIC ACID; CLINDAMYCIN; CLORURO SODICO 7%; COLIMICINA - 1000000 U/4 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE1 FLACONCINO POLVERE + 1 FIALA SOLVENTE 4 ML; COLIMYCINE inhalation; COLIMYCINE injectable; COLISTIMETATO SODICO; COLISTIMETHATE; COLISTIMETHATE SODIUM; COLISTIMETHATE SODIUM (A COMPONENT); COLISTIN; COLISTIN MESILATE SODIUM; COLISTINEB 2MUI; CPX; CR002; CR002 Liquid API; CRC3357, ZK-355322, Leukoton; CREON; CREON 10000 Capsules; CREON IR; CREON N 25000; CSL787; CTX-4430; CURCUMIN; CYC202; CYCLO[L-ALANYL-L-SERYL-L-ISOLEUCYL-L-PROLYL-L-PROLYL-L-GLUTAMINYL-L-LYSYL-L-TYROSYL-D-PROLYL-L-PROLYL-(2S)-2-AMINODECANOYL-L-ALPHA-GLUTAMYL-L-THREONYL]; Calcium; Calcium carbonate; Calfactant; Carbonate; Cavosonstat; Cayston; Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler; Cayston Aztreonam 75 mg powder and solvent for nebuliser solution; Cefalexin; Cefepime; Ceftaroline; Ceftazidim; Ceftazidim Fresenius Kabi; Ceftazidim Fresenius Kabi 2000 mg poeder voor oplossing voor injectie of infusie; Ceftazidime; Ceftazidime and tobramycin; Ceftazidime/avibactam; Ceftolozane; Ceftolozane/Tazobactam; Cefuroxim; Cefuroxime; Cephalexin; Cftr Modulators; Chlorhexidine; Chlorhexidine Gluconate; Chlorhexidine gluconate oral rinse; Chloride; Cholecalciferol; Cholecalciferol (Vitamin D3); Cholecalciferol (vitaminD3); Choline; Choline Chloride; Choline supplementation; Chronic Antioxidant; Cipro (Ciprofloxacin, BAYQ3939); Cipro Inhale; Ciprofloxacin; Ciprofloxacin (BAYQ3939) dry powder for inhalation; Ciprofloxacin (Cipro Inhale, BAYQ3939); Ciprofloxacin (Cipro, BAYQ3939); Ciprofloxacin (ciproxin); Ciprofloxacin DPI; Ciprofloxacin DPI (BAYQ3939); Ciprofloxacin Hydrochloride; Ciprofloxacin Inhale; Ciprofloxacin dispersion for inhalation; Ciprofloxacin for Inhalation; Ciprofloxacin hydrochloride; Ciproxin; Ciproxin Suspension; Clarithromycin; Claritromycin; Claritromycin 500mg film coated tablets; Clavulanate; Clavulanic acid; Clindamycin; Cobamamide; Colimicina; Colimycine; Colistimethat-Natrium; Colistimethate; Colistimethate 75 mg inhaled two times daily; Colistimethate Sodium; Colistimethate sodium; Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate; Colistimethate sodium (promixin); Colistin; Colistin CF; Colistin Forest - Trockenstechampullen mit Lösungsmittel; Colistineb; Colobreathe; Colomycin; Compound 1a; Continuous infusion Cefepime; Continuous infusion Ceftazidime; Continuous infusion Meropenem; Continuous infusion Piperacillin tazobactam; Continuous infusion Ticarcillin-clavulanate; Control; Control Group 0.9% Isotonic Saline; Control multivitamin; Creon 10.000, hårde enterokapsler; Creon 10000; Creon 25.000, hårde enterokapsler; Creon 25000; Creon 40.000, hårde enterokapsler; Creon IR; Creon N; Creon®; Creon® (DR/GR); Creon® 25,000; Crestor; Curcuma Longa; Curcuma Longa Extract; Curcuma Longa Extract cpl formaat 00 23,2 x 8,5 mm 723 mg; Curcumin; Cystagon; Cystagon (cysteamine bitartrate) immediate-release capsules; Cysteamine; Cysteamine bitartrate; Cysteamine bitartrate (Cystagon); Cystic Fibrosis Ready to Use Supplemental Food; D-a-tocopheryl PEG 1000 succinate; D-glucitol; D6-25-hydroxyvitamin D3; DCI; DCI 1020; DEPELESTAT; DEUTIVACAFTOR; DHA; DICLOXACILLIN; DORIBAX; DORIPENEM HYDRATE; DORNASE ALFA; DOXYCYCLINE; DP Mannitol; DTPA; DURAMYCIN; DX-890; Decolonization; Denosumab; Denufosol; Denufosol Tetrasodium (INS37217) Inhalation Solution; Denufosol tetrasodium (INS37217); Denufosol tetrasodium (INS37217) Inhalation Solution; Denufosol tetrasodium Inhalation Solution; Depelestat; Desoxyribonuclease; Detemir; Detoxifying agents for antineoplastic treatment; Deuterated Ivacaftor; Deutivacaftor; Device: 129Xe Small and Large Human Lung Coil; Device: 3He Human Lung Coil; Device: Continuous Glucose Monitoring; Device: Continuous glucose monitor (CGM); Device: Frequently Sampled Oral Glucose Tolerance Test and CGM; Device: HFNT during exercise; Device: High flow nasal oxygen cannula; Device: Home Oral Glucose Tolerance Test kit; Device: Insulin Pump; Device: Lung Clearance Index; Device: Macroduct sweat stimulator; Device: Magnetic Resonance Imaging; Device: Manuka honey sinus rinse; Device: Nocturnal oxygen , nocturnal bi-level positive pressure ventilation; Device: Non invasive ventilation; Device: Noninvasive ventilation; Device: Oxygen; Device: PARI eFlow nebulizer system; Device: PFP and SF6 Human Lung Coil; Device: Perform three multiple breath nitrogen washout tests (N2-MBW-test); Device: Positive expiratory pressure; Device: RELiZORB (immobilized lipase) cartridge; Device: SmartPill Motility System & PillCam Patency Capsule; Device: Sperti Del Sol Lamp; Device: Standard oxygen therapy/RA; Device: Standard sinus rinse; Device: Tobi Podhaler; Device: activated smart device; Device: de-activated smart device; Dexamethasone; Dexamethasone sodium phosphate 250 mg/10 ml solution; Diagnostic Test: Candy Glucose Tolerance Test; Diagnostic Test: Continuous glucose monitoring; Diagnostic Test: Dexa scan; Diagnostic Test: Infant PFT; Diagnostic Test: Injected abdominal CT; Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpine; Diagnostic Test: Lung Clearance Index; Diagnostic Test: Measurement of Sweat Chloride and Sweat Bromide; Diagnostic Test: Nasal brushing; Diagnostic Test: Oral glucose tolerance test; Diagnostic Test: Passive tidal breathing; Dicloxacillin; Diet; Digitoxin; Docosahexaenoic acid; Docosahexaenoic acid (DHA); Docosahexaenoic acid administration: 50 mg/kg/day during 12 months; Docosahexanoic Acid Supplement; Doribax; Doripenem; Dornase alfa; Dornase alfa (Pulmozyme); Dornase alfa [Pulmozyme®]; Dornase alpha; Doxycyclin; Doxycycline; Dry powder tobramycin; Duramycin; Duramycin, 2622U90; ECGC; EGCG; EGCG + Tocotrienol; ELEXACAFTOR; ELX; ELX (VX-445)/TEZ (VX-661)/IVA (VX-770); ELX-02; ELX/TEZ/IVA; EMEA/H/C/000125; EPI-hNE4 DX-890; EU Orphan Designation Number EU/3/02/120; EUR-1008; EUR-1008 (APT-1008); EUR-1008 25,000 Units; EZ-2053; EZ-2053 5mg/kg; Ebselen; Elexacaftor; Elexacaftor-tezacaftor-ivacaftor exposure; Engineerd Protein Inhibitor of human Neutrophil Elastase; Engineered Protein Inhibitor of human Neutrophil Elastase; Ensure High Protein; Ensure plus; Ergocalciferol; Ergocalciferol (vitamin D2); Esomeprazole; Essential amino acid intake + Leucine vs total AA supplement; Estradiol; Estradiol 2 mg; Ethambutol; Ethinyl estradiol; F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid); FDL169; FDL176; FDL176 & FDL169 coadministration; FLUCLOXACILLIN; FLUCLOXACILLIN SODIUM; FORLAX 4 g, poudre pour solution buvable en sachet; FTI, AZLI; FUSIDIC ACID; Fenretinide; Ferinject; Ferric carboxymaltose; Ferrous sulfate 325mg; Finely ground flaxseed powder; Fish oil; Flaxseed; FluMist; Flucloxacillin; Flucloxacillin 250mg/5ml Sugar-Free Powder for Oral Solution; Flucloxicillin; Flumist®; Fluticasone; Formoterol; Fortum; Fucidin; Fucidin Tablets; Fusidic acid; Fusidin; G1117337; G914167; G957389; GENISTEIN; GIP; GLP-1; GLPG1837; GLPG1837 dose 1; GLPG1837 dose 2; GLPG1837 dose 3; GLPG2222; GLPG2222 100 mg; GLPG2222 150 mg q.d.; GLPG2222 200 mg; GLPG2222 300 mg q.d.; GLPG2222 400 mg; GLPG2222 50 mg; GLPG2451 dose regimen A; GLPG2451 dose regimen B; GLPG2737; GLPG2737 single dose; GLPG3067; GLPG3067 single dose; GLUTATHIONE; GLUTATHIONE SODIUM; GS-5737; GS-5745; GS-9411; GSH; GSH (Glutathione); Galicaftor; Gallium nitrate; Garlic; Genetic: Blood or Saliva Sample Collection; Genistein; Genistein (Unconjugated Isoflavones 100); Genisteine Plus 150 mg cpl formaat 1 18,7 x 6,4 mm 438 mg; Gentamicin; Gernebcin; Gernebcin 80 mg; Ghrelin; Giving DHA-rich supplement; Glargine; Glargine insulin; Glucose; Glutamine; Glutathione; Glycine; Glycine Buffer; Gold; Growth Hormone; Growth hormone; HEPARIN SODIUM; HMSCs; HP 129Xe; HP 3He; HYPERTONIC SALINE; Helium; Helium-3; Heparin; Heparin 25mg inhalation powder, hard capsule; Heracillin; High dose of budesonide; High-Dose Vitamin D3; Honey; Human recombinant growth hormone; Hyaluronan; Hydrocortisone; Hydroxychloroquine; Hyperglycemic Clamp with concurrent GIP infusion; Hyperglycemic clamp; Hyperglycemic clamp with concurrent GLP-1 infusion; Hyperpolarized Helium-3; Hyperpolarized Helium-3 MRI of the chest; Hyperpolarized Xe129; Hyperpolarized Xenon; Hyperpolarized Xenon 129; Hyperpolarized Xenon gas; Hyperpolarized xenon-129; Hypertonic Saline; Hypertonic Saline 7%; Hypertonic bicarbonate; Hypertonic saline; Hypertonic saline (7 %) and isotonic saline (0.9%); Hypertonic saline (7%); Hypertonic saline 6% -; Hypertonic saline 7%; Hypertonic saline solution; ICS+LABA; IDPM; IDPM: Inhaled Dry Powder Mannitol; IGE025; INCRELEX*SC 1FL 4ML 10MG/ML; INDUSIL*OS GTT FL 30MG+FL 15ML; INOmax; INOmax 400ppm mol/mol inhalation gas; INS1007; INS1007 10 mg oral tablet; INS1007 25 mg oral tablet; IONIS-ENaCRx; ISOTONIC SALINE; ITRACONAZOLE; IV amikacin; IV ceftazidime; IV meropenem; IV piperacillin-tazobactam; IV ticarcillin-clavulanate; IV tobramycin; IV vancomycin hydrochloride; IVA; IVACAFTOR; Ibuprofen; Icenticaftor; IgY; Impact; Impact-Nutridrink; Increlex; Indium; Indium-DTPA; Influenza vaccination; Inhaled 7% hypertonic saline (HS); Inhaled AR-501; Inhaled Dry Powder Mannitol; Inhaled Mannitol; Inhaled Reduced Glutathione; Inhaled SNSP113; Inhaled Sodium Pyruvate; Inhaled Vancomycin; Inhaled dry powder mannitol; Inhaled hypertonic saline (7%); Inhaled mannitol; Inhaled tobramycin; Initiation of CFTR Modulator; Inomax; Insulin; Insulin Asparte; Insulin detemir; Insulin detemir [rDNA origin] injection; Insulin glargine; Insuline humaine recombinante; Interferon Gamma; Interferon gamma-1b; Intermittent, short infusion Cefepime; Intermittent, short infusion Ceftazidime; Intermittent, short infusion Meropenem; Intermittent, short infusion Piperacillin tazobactam; Intermittent, short infusion Ticarcillin-clavulanate; Inulin; Isotonic Saline; Isotonic saline; Isotonic saline 0.9%; Itraconazole; Itraconazole/voriconazole; Ivacaftor; Ivacaftor (proposed INN); Ivacaftor 125mg tablet; Ivacaftor 150 mg; Ivacaftor 150 mg or 250 mg; Ivacaftor 25 mg/75 mg; Ivacaftor 75 mg; Ivacaftor 75 mg/150 mg; Ivacaftor Exposed; Ivacaftor or elexacaftor/tezacaftor/ivacaftor; Ivacaftor+lumacaftor; Ivacaftor/Ataluren; Ivacaftor/Kalydeco; J01GB01; JBT-101; JBT-101 (lenabasum); KB001; KB001-A; KREON 25000; KREON N 25000; KREON de Liberación Inmediata; Kalydeco; Kalydeco 150 mg film-c; Kalydeco 150 mg film-coated tablets; Kalydeco 150mg; Kineret; Klacid; Kreon 25 000; Kreon 25,000 Units; Kreon 25000; Kreon® 25,000; L-Glutamine; L-Lysine; L-Lysine N acetylcysteinate; L-Lysine N-acetylcysteinate; L-Lysine- N-acetylcysteinate; L-Lysine-N-acetyl-L-cysteinate; L-Lysine-N-acetylcysteinate; L-alanine; L-arginine; LABA/LAMA; LANTUS*SC 5CAR3ML100UI/ML; LAU-7b; LENABASUM; LEVOFLOXACIN HEMIHYDRATE; LINEZOLID; LIPASA; LIPASE; LIPASE LIP2; LU 70274; LUM; LUM/IVA; LUM/IVA fixed-dose combination; LUMACAFTOR; Lactic acid; Lactic acid producing organisms; Lactizole nebulization; Lactobacillus reuteri; Lactobacillus rhamnosus; Lactobacillus rhamnosus GG; Lansoprazole; Lantus 100 units/ml solution for injection in a cartridge; Lantus® 100 Units/ml solution for injection in a vial. Lantus® 100 Units/ml solution for injection in a cartridge. Lantus® 100 Units/ml solution for injection in a pre-filled pen; Lenabasum; Lenabasum 20 mg; Lenabasum 5 mg; Leucine; Levemir; Levemir 100 U/ml solution for injection in a cartridge, Levemir 100 U/ml solution for injection in a pre-filled pen; Levemir FlexPen; Levemir Penfill; Levemir insulin; Levofloxacin; Levofloxacin Kabi; Levofloxacin hemihydrate; Linez; Linezolid; Linoleic acid; Linoleic acid supplementation; Lipase CLEC; Lipase Lip2 from Yarrowia lipolytica; Lipitor; Liposomal Amikacin; Liposomal Amikacin (Arikace TM); Liposomal Amikacin (Arikace™); Liposomal amikacin for inhalation; Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer.; Liposomal amphotericin B (Ambisome®); Liprotamasa; Liprotamase; Liprotamase Powder for Oral Solution; Loestrin (norethindrone acetate and ethinyl estradiol); Lonodelestat; Losartan; Lubiprostone; Lucinactant; Lucinactant first; Lumacaftor; Lumacaftor / ivacaftor; Lumacaftor Plus Ivacaftor Combination; Lumacaftor plus Ivacaftor; Lumacaftor, Ivacaftor Drug Combination; Lumacaftor-Ivacaftor treatment; Lumacaftor-ivacaftor; Lumacaftor/Ivacaftor; Lumacaftor/ivacaftor; Lumacaftor/ivacaftor 100mg/125mg tablets; Lumacaftor/ivacaftor 200mg/125mg; Lumacaftor/ivacaftor 200mg/125mg tablets; Lumacaftor/ivacaftor 200mg/83mg tablet; Lym-X-Sorb powder; Lysine; Lysomucil 10 %; MAG-DHA; MANNITOL; MECASERMIN; MEROPENEM; MEROPENEM TRIHYDRATE; MINOCYCLINE HYDROCHLORIDE; MMF; MOLI 1901; MONITOR; MP-376; MP-376 (Levofloxacin Solution for Inhalation); MP-376 (Levofloxacin solution for Inhalation); MRI with PFP; MRT5005; MS1819; MS1819-SD; MSI-1995; MTT; Macrogol; Macrogol 4000; Mannite; Mannitol; Mannitol + pulmozyme; Mannitol inhalation powder; Matched isoglycemic clamp; Mecasermin; Medical Grade Oxygen; Melphalan; Menadiol Diphosphate; Menadiol diphosphate; Menadiol sodium diphosphate; Meropenem; Meropenem Fresenius Kabi; Meropenem Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie; Meropenem Infusion; Mesenchymal Stem Cells; Metformin; Metformin Hydrochloride; Metformine; Metformine HCL 500 PCH; Miglustat; Minocycline; Modified Oral Glucose Tolerance Test (50g 4-hours); Modified lipid formulation; Molgramostim; Molgramostim nebulizer solution; Moli 1901; Moli 1901 (2622U90, duramycin); Moli1901; Moli1901 (2622U90, duramycin); Moxifloxacin; Moxifloxacin hydrochloride; Mucoid exopolysaccharide P. aeruginosa immune globulin IV; Mucolysin; Mucomyst; Multienzymes (lipase, protease etc.); Mupirocin; Mupirocin Intranasal Creme; N-(5-hydroxy-2,4- bis(trimethylsilyl)phenyl)-4-oxo- 1,4-dihydroquinoline-3-carboxamide; N-(5-hydroxy-2,4-bis(trimethylsilyl)phenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide; N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide; N-acetylcystein; N-acetylcysteine; N-acetylcysteine (NAC); N6022; N91115; NAC; NAL; NEB/01-07; NEBCINE; NO; NOXAFIL - 40 MG/ML SOSPENSIONE ORALE USO ORALE FLACONE (VETRO) 105 ML 1 FLACONE; NR; Nacystelyn; Nacystelyn®; Nasal Aztreonam; Nebcin; Nebcin (tobramycin); Nebcinal; Nebcinal Tobi; Nebulization of Amikacin during NIV (RR: 15 cycles/minute); Nebulization of Amikacin during NIV (RR: 25 cycles/minute); Nebulization tobramycin; Nexium; Nexium 20; Nitrate; Nitric Oxide; Nitric Oxide 160 ppm; Nitric Oxide for Inhalation; Nitric oxide; Nitrite; Nitrogen; None; None assigned; Norethindrone; Norgestimate; Normal Saline; Normal saline; Normal saline IV, salt tablets; Normal saline solution; Normal saline:; Norvir; Norvir 100 mg film-coated tablets; Novamin; Novo Rapid; Novo Rapid Insulin (Novonordisk); NovoNorm 0.5 mg; NovoNorm 1 mg; NovoNorm 2 mg; NovoRapid 100 U/ml, solution for injection in a vial. NovoRapid Penfill 100 U/ml, solution for injection in a cartridge. NovoRapid FlexPen 100 U/ml, solution for injection in a pre-filled pen.; NovoRapid Aspartate; Novolog insulin; Novorapid / humalog short acting insulin; Noxafil; Noxafil - oral suspension 40 mg/ml; Noxafil 100 mg; Noxafil®; Nutridrink-Impact; Nutropin AQ; Nutropin AQ [somatropin (DNA origin) injection]; OGT 918; OLIGOG CF-5/20; OMEGA-3-ACID TRIGLYCERIDES; OSCN-; Oleic Acid; Oleic acid supplementation; OligoG; OligoG (60 mg/ml); OligoG CF-5/20; OligoG CF-5/20 - 17.5 mg; OligoG CF-5/20, 17,5 mg, Hartkapsel mit Pulver zur Inhalation; OligoG CF/20 - 27.5 mg; OligoG CF/20 - 37.5 mg; OligoG CF/20, 27,5 mg, Hartkapsel mit Pulver zur Inhalation; OligoG CF/20, 37,5 mg, Hartkapsel mit Pulver zur Inhalation; OligoG DPI; OligoG Dry powder for inhalation; OligoG-CF5/20, Alginate oligosaccharide (G-block) fragment; Oligomer of Sodium Alginate; Omadacycline; Omadacycline Injection [Nuzyra]; Omadacycline Oral Tablet [Nuzyra]; Omalizumab; Omega 3; Omega 3 Premium; Omega-3; Omega-3 triglycerides; Omeprazole; Omeprazole 40mg Capsule; Once-daily insulin detemir; Oral Aztreonam; Oral Glucose Tolerance test (75g 2-hour); Oral Glutathione; Oral ciprofloxacin; Oral ciprofloxacin plus inhaled colistin; Oral reduced l-glutathione; Oral roflumilast; Orkambi; Orkambi 100 mg/125 mg film-coated tablets; Orkambi 200 mg/125 mg film-coated tablets; Orkambi: contains lumacaftor and ivacaftor; Orkambi®; Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg; Oseltamivir; Osmohale; Other non-sponsor pancreatic enzyme replacement therapy; Other respiratory system products; Other: A-STEP; Other: A-STEP (New Protocol); Other: Absorptive clearance scan; Other: Air - oxygen; Other: Autogenic drainage; Other: Balance; Other: Blood glucose results; Other: Comparator: CPET cycle ergometer (Gold Standard); Other: Continuation of dornase alfa (dnase); Other: Continuation of hypertonic saline (HS); Other: Diagnostics for glucose tolerance with 3 different methods.; Other: Discontinuation of dornase alfa (dnase); Other: Discontinuation of hypertonic saline (HS); Other: Exercise capacity; Other: Fruit juice; Other: Glucose -potentiated arginine (GPA) stimulation tests; Other: Glucose profile for 2 weeks; Other: Hepatic elastography; Other: High Glycemic Index Meal; Other: Hyperpolarized Xenon MRI; Other: Hypoglycemic Clamp; Other: Impact Peptide 1.5; Other: Inhalable Hypertonic saline 7%; Other: Inhalable Hypertonic saline 7% + Hyaluronan 0.1%; Other: Liquid Meal Test (Carbohydrate-rich); Other: Liquid Meal Test (Fat-rich); Other: Liquid Meal Test (Mixed); Other: Low Glycemic Index Meal; Other: Mixed Meal Tolerance Test; Other: Mixed meal test evaluation test arm; Other: Muscle oxygenation; Other: No doxycycline; Other: No pancreatic enzyme replacement therapy; Other: Non-hormonal period; Other: OGTT; Other: On-demand treatment; Other: Ophthalmologic examinations; Other: Oral Glucose Tolerance Test; Other: Oral Glucose Tolerance Test (OGTT) assessment arm; Other: Oxygen - Air; Other: Pentadecanoic acid (PA) and Triheptadecanoin (THA); Other: Reaction Time and Postural Control; Other: Sham Comparator; Other: Sputum Sample; Other: Sputum sample; Other: Stool Sample; Other: Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA; Other: Test Soda; Other: Tobacco questionnaire; Other: Tobramycin time of administration; Other: blood sample; Other: glucose solution at a dose of 1.75 g/kg (up to a maximum of 75 g) for the OGTT and glucose solution at a dose of 0.5 g/kg (up to a maximum of 35 g) was injected in 2.5-3 min for the IGTT; Other: measure of endothelial function; Other: quercetin; Other: routine therapy; Oxygen; P-1037; PAAG15; PANCREASE MT; PANCREASLIPASE; PANCREATIN; PANCREATIN (PAncreas Powder); PANCREATIN (Pancreas Powder); PANCREATINA; PANCREATINA (Páncreas Polvo; PANCREATINA (Páncreas Polvo); PANCREAZE; PANCREAZE®; PANCRECARB® (pancrelipase); PANCRELIPASE AMYLASE; PANZYTRAT 25000; PBI4050; PC945; PEG; PERTZYE; PFP; PFT; PGM169/GL67A; PIPERACILLIN; PIPERACILLIN SODIUM; PL 0010/0211; PO azithromycin; PO ciprofloxacin; POL6014; POL7080; POSACONAZOLO; PPI treatment; PREFOLIC*30CPR GASTROR 15MG; PROMIXIN*NEBUL 30MONOD 1MUI; PROTEASA; PROTEASE; PTC-0161480; PTC-124; PTC-C124; PTC124; PTI-428; PTI-801; PTI-808; PUR118; Pancreas Powder; Pancrease; Pancrease MT 10.5, or MT 21; Pancreatin; Pancrelipase; Pancrelipase Delayed Release; Pancrelipase Delayed Release Capsule; Pancrelipase Microtablets; Pancrelipase amylase; Pancrelipase microtablets; Pancrelipase with bicarbonate; Pancrelipase/Pancreas Powder; Pankreatin; Panzytrat® 25,000; Panzytrat® ok; Perfluorinated gas/oxygen mixture; Phenylbutyrate; Phosphate; Physiologic serum nebulized nasally; Physiological solution; Pilocarpine; Pilocarpine Nitrate 5%; Pioglitazone; Piperacillin; Piperacillin sodium , tazobactam sodium; Piperacillin with Tazobactam (tazocin); Piperacillin-tazobactam combination product; Piperacillin/Tazobactam; Piperacillin/Tazobactam Kabi - Fresenius Kabi Austria; Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie; Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie; Plerixafor; Plerixafor mobilization of autologous CD117 stem cells; Polyethylene Glycol 3350; Polyethylene glycol; Porcine (pig) PERT; Porcine PERT; Posaconazole; Posaconazolo; Prednisolone; Prednisone; Procedure: Airway clearance technique; Procedure: Blood draw; Procedure: Blood draw.; Procedure: Blood sampling for determination of serum Zn; Procedure: Continuous Glucose Monitoring System (CGMS); Procedure: Dual Energy X-ray Absorptiometry (DEXA); Procedure: Exhaled Nitric Oxide; Procedure: FDG-PET; Procedure: Growth Hormone Stimulation Test; Procedure: HGPIV diagnosis test; Procedure: HOMAR-IR diagnosis test; Procedure: History and physical exam.; Procedure: IV glucose tolerance test; Procedure: Indirect Calorimetry; Procedure: Oral Glucose Tolerance Test; Procedure: Oral Glucose tolerance test; Procedure: Physiotherapy, exercise, percutaneous gastrostomy feeds; Procedure: Pulmonary Function Testing; Procedure: Pulmonary function testing.; Procedure: Sputum Collection; Procedure: Urinary collect; Procedure: Whole body Protein Turnover; Procedure: Whole body Protein Turnover Study; Procedure: Whole body protein turnover; Procedure: bronchoscopy with BAL; Procedure: sodium bicarbonate; Procedure: spirometry; Prograft capsules; Prolastin; Prolastin (drug); Promixin; Promixin 1 million International Units (IU) Powder for Nebuliser Solution; Promixin, 1 million International Units (IU) Powder for Nebuliser Solution; Promixin,1 millón de Unidades Internacionales,polvo para solución para inhalación por nebulizador; Promixin/Tadim; Protease; PsAer IgY; Pulmaquin®; Pulmozyme; Pulmozyme (Dornase alpha); Pulmozyme (dornase alfa); Pulmozyme single use ampule; Pulmozyme®; QAU145; QBW251; QBW276; QBW276 1500mcg; QBW276 300mcg; QBW276 Succinate; QR-010; Quercetin; R03AC02; R03CC02; R05C B01; RIFAMPICIN; RIOCIGUAT; RPL554; RPS 2505; Radiation: MRI Pancreas and Liver; Radiolabelled OligoG CF-5/20 6% Solution; Radiolabelled OligoG CF-5/20 6% Solution for Nebulisation; Radiolabelled OligoG CF-5/20 DPI; Radiolabelled OligoG CF-5/20 Dry Powder for Inhalation (DPI); Rapeglinide; Ravicti; Ravicti high dose; Ravicti low dose; Recombiant human Desoxyribonuclease ( rhDNase); Recombinant Human DNase (Pulmozyme); Recombinant human IGF-1; Recombinant humanized monoclonal antibody omalizumab to IgE; Recombinant truncated SPINT2 protease inhibitor; Red Blood Cell Zn; Reduced glutathione; Reduced glutathione sodium salt; Repaglinide; Repaglinide and Insulin; Reparixin; Resunab, ajulemic acid, anabasum; Resveratrol; RhBSSL; RhDNAse; Rifampicin; Rifampin; Rimactan; Riociguat; Riociguat (Adempas, BAY63-2521); Roflumilast; Roflumilast Oral Tablet; Roscovitine; Rosuvastatin; Rosuvastatin calcium; Roxithromycin; Répaglinide; S-1226; SALBUTAMOL; SALINE; SB-656933 Tablets; SB-656933-AAA; SB656933; SE10599; SELICICLIB; SF6; SIN ASIGNAR; SLIT Amikacin; SLIT(TM) Amikacin; SMX; SNSP113; SODIUM ALGINATE; SODIUM BICARBONATE BP; SODIUM CHLORIDE; SODIUM CHLORIDE 7%; SODIUM CHLORIDE PH. EUR.; SODIUM CHLORIDE SOLUTION 0.9%; SPI-1005 Ebselen 200mg Capsule x1; SPI-1005 Ebselen 200mg Capsule x2; SPI-1005 Ebselen 200mg Capsule x3; SPORANOX; SPX-101; STERILE PYROGEN-FREE ISOTONIC NACL SOLUTE (0.9% W / V); SUB185183; SULFAMETHOXAZOLE; Salbutamol; Saline; Saline 0.9% inhalation solution; Saline Solution; Salmeterol; Saxagliptin; Seliciclib; Serum Zn; Short-acting Insulin (Actrapid); Sildenafil; Sildenafil (Acute-1 hour); Sildenafil (Subchronic-4 weeks); Sildenafil 40mg oral capsule; Simvastatin; Simvastatin treatment for 28 days; Sitagliptin; Snack beverage; Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca; Sodium 4-Phenylbutyrate; Sodium 4-Phenylbutyrate (4PBA); Sodium Bicarbonate; Sodium Chloride; Sodium Pyruvate in 0.9% Sodium Chloride Solution; Sodium alginate; Sodium bicarbonate; Sodium chloride; Sodium chloride (7%); Sodium chloride 0,9%; Sodium chloride 6%; Sodium chloride 7%; Sodium nitrite; Soluble fiber supplementation; Somalgen; Somatropin; Spiriva; Spiriva Respimat; Spiriva Respimat 2.5 mcg; Spiriva Respimat 2.5 microgram; Spiriva Respimat 2.5 microgram, solution for inhalation; Sporanox; Sporanox 10 mg/ml Oral Solution; Sputum; Ss-Adrenergic cocktail; Standard Care; Standard Formula; Standard formula (Enfamil); Standard of care IV antibiotic(s); Standardized turmeric root extract; Study medication, azithromycin; Sulfamethoxazole; Sulfate; Sulfato de amikacina; Sulfur Colloid; Sunflower Oil; Sunflower oil; Supplementation with vitamin D2/D3; Symbiotic Formula with DHA and antioxidants; Symdeko; Symkevi; Symkevi 100mg/150mg Film-coated tablets; Synrinse; T 100 PARI; T-326; T100; T100 PARI; TACROLIMUS; TAD 600; TAFLUPROST; TAZOBACTAM; TAZOBACTAM SODIUM; TBD; TBM100; TBM100C; TEZ; TEZ/IVA; TEZACAFTOR; THA; TIOTROPIUM; TIOTROPIUM BROMIDE MONOHYDRATE; TIP; TIP (Tobramycin inhalation powder); TIS (Tobramycin Inhalation Solution); TIS or TIP; TMP; TNSE; TOBI; TOBI (tobramycin); TOBI 300 mg / 5 mL nebuliser solution; TOBI 300 mg/5 ml Lösung für einen; TOBI 300 mg/5 ml Lösung für einen Vernebler; TOBI 300 mg/5 ml Nebuliser Solution; TOBI 300 mg/5 ml solución para inhalación por nebulizador; TOBI 300 mg/5 ml, solution pour inhalation par nébuliseur; TOBI 300mg/ 5ml solución para inhalación con nebulizador; TOBI 300mg/5mL Nebuliser Solution; TOBI 300mg/5mL nebuliser solution; TOBI 300mg/5ml Nebuliser solution; TOBI PODHALER; TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE; TOBI PODHALER*448CPS 28MG+10IN; TOBI Podhaler; TOBI Podhaler 28 mg Hartkapseln mit Pulver zur Inhalation; TOBI Podhaler 28 mg inhalációs por, kemény kapszula; TOBI*NEBUL 56F 1D 300MG/5ML; TOBI®; TOBI™ Podhaler™ 112 mg inhaled twice daily; TOBRAMICINA; TOBRAMYCIN; TOBRAMYCIN SULFATE; TR02; TRIMETHOPRIM; Tacrolimus; Tacrolimus and MMF; Tacrolimus capsules; Tacrolimus prolonged-release hard capsules; Tad; Tadim; Tafluprost; Talniflumate; Tauroursodeoxycholic acid; Tazobactam; Technetium Sulfur Colloid; Tedizolid; Tedizolid IV; Tedizolid PO; Tefibazumab; Teicoplanin; Teicoplanin Sandoz 200 mg powder and solvent for solution for injection or infusion or oral solution.; Telavancin; Telavancin Injection; Tezacaftor; Tezacaftor (TEZ); Tezacaftor/Ivacaftor; Tezacaftor/Ivacaftor + Ivacaftor; Tezacaftor/Ivacaftor 100mg/150mg; Tezacaftor/Ivacaftor/100mg/150mg; Tezacaftor/ivacaftor; Tezacaftor/ivacaftor 100mg/150mg; Tham; The gut mycobiota and microbiota profile; The lung mycobiota and microbiota profile; Theophylline; Ticarcillin; Tigerase®; Tiotropium; Tiotropium Bromide (monohydrate); Tiotropium Respimat; Tiotropium Respimat 1.25 microgram solution for inhalation; Tiotropium Respimat 1.25 microgram, solution for inhalation; Tiotropium Respimat 1.25 micrograms solution for inhalation; Tiotropium Respimat® inhaler; Tiotropium bromide; Tiotropium bromide 5 mcg; Tiotropium bromide high; Tiotropium bromide low; Tiotropium bromide medium; Tiotropium bromide monohydrate; Tiotropium bromide-low dose-2.5mcg; Tobacco; Tobi; Tobi 300 mg/5 ml Nebuliser Solution; Tobi 300mg/5ml Nebuliser solution.; Tobi 300mg/5ml Solución para inhalación por nebulizador.; Tobi Inhalant Product; Tobi Nebcinal; Tobramcyin; Tobramicina; Tobramicina polvere inalatoria; Tobramycin; Tobramycin (Gernebcin®); Tobramycin / Bramitob; Tobramycin / TOBI; Tobramycin 100 PARI; Tobramycin Inhalation Powder; Tobramycin Inhalation Powder (TIP); Tobramycin Inhalation Powder TIP delivered by the T-326 Inhaler; Tobramycin Inhalation Solution (TIS); Tobramycin Powder; Tobramycin Solution for Inhalation; Tobramycin Steri-Neb 300 mg/5 ml, inhalation solution; Tobramycin dry powder; Tobramycin for Inhalation; Tobramycin inhalation powder; Tobramycin inhalation solution; Tobramycin inhalation solution using a PARI LC® Plus nebulizer.; Tobramycin injection 40mg/1ml; Tobramycin nebulized nasally; Tobramycin solution for inhalation; Tobramycin solution for inhalation (TOBI); Tobramycin solution for inhalation 300 mg; Tobramycine; Tobramycinum; Tobrineb/Bramitob; Tocotrienol; Treatment; Treatment with polyethylene glycol (Macrogol 4000); Trifakta; Trikafta; Trimethoprim; Trimethoprim Sulfamethoxazole (TMP/SMX); Trimethoprim and Sulfamethoxazole; Trimethoprim-sulfamethoxazole; Trimethoprim/Sulfamethoxazole; Trimethoprim/Sulfamethoxazole (TMP/SMX); Trimetoprim; Triple combination therapy; Turmeric; ULTRESA; Ultrase; Ultrase® MT12; Ultrase® MT20; Unconjugated Isoflavones 100 (PTI G-4660, 87% Genistein); Uridine; Urinary levels of PIIINP as a marker of changes in renal function; Ursodiol; V-Fend; VEDROP; VFEND 40 mg/ml powder for oral suspension; VITAMIN E - TGPS; VORICONAZOLE; VR496; VRT-813077; VRT-826809; VRT-893661; VRT-893661 VRT-0893661; VX-121; VX-152; VX-371; VX-371 in hypertonic saline; VX-371 in saline; VX-440; VX-445; VX-445 / TEZ / IVA; VX-445 / TEZ / IVA FDC; VX-445 /TEZ/IVA; VX-445/TEZ/IVA; VX-561; VX-561 (CTP-656); VX-659; VX-659/ TEZ/IVA; VX-659/TEZ/IVA; VX-659/Tezacaftor/Ivacaftor; VX-661; VX-661 / VX-770; VX-661 Plus Ivacaftor Combination; VX-661 plus ivacaftor combination; VX-661, VRT-893661; VX-661/Ivacaftor; VX-661/VX-770; VX-661/VX-770 (TEZ/IVA); VX-661/ivacaftor (VX-770) 100mg/150 mg; VX-661/ivacaftor 100 mg/ 150 mg; VX-661/ivacaftor 100mg/150 mg; VX-661/ivacaftor 100mg/150mg; VX-661/ivacaftor 50 mg/ 75 mg; VX-770; VX-770, VRT-8130077; VX-770, VRT-813077; VX-809; VX-809 & VX-770; VX-809 / VX-770; VX-809, VRT-826809; VX-809/VX-770; Vaccin grippal pandémique H1N1; Vaccination with vaccine against hepatitis A and B; Valganciclovir; Valganciclovir [Valcyte]; Vancomycin; Vancomycin hydrochloride inhalation powder; Vancomycin inhalation powder; Vantobra (tobramycin); Vardenafil; Vedrop; Vfend; Vitamin B12; Vitamin D; Vitamin D Oil; Vitamin D Powder; Vitamin D2; Vitamin D3; Vitamin E; Vitamin K; Vitamin K supplementation, dose #1; Vitamin K supplementation, dose #2; Vitamin: Choline Bitartrate (2-hydroxyethyl) trimethylammonium salt 1:1; Voriconazole; WATER FOR INJECTIONS, EP; Water; Water for injections; XOLAIR; Xenon; Xenon-129; Xolair; Xolair 150 mg Pulver und Injektionslösung zur Herstellung einer Injektionslösung; Xylitol; ZENPEP; ZITHOMAX 40 mg/ml ENFANTS; ZITHROMAX; ZITHROMAX 250 mg; Zavesca; Zenpep; Zinc; Zinc acetate; Zinc acetate (20mg/d); Zithromax; Zitromax; Zn; Zoledronic acid; [N/A]; [NA]; [SPX-101]; [na]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2016-001785-29-IE (EUCTR)	15/08/2016	10/05/2016	Study of the effects of combined treatment with the CFTR corrector ivacaftor and IV antibiotics on infection in CF.	Combined Effect of CFTR Modifiers and Intensive Antibiotic Treatment	Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Kalydeco INN or Proposed INN: IVACAFTOR Trade Name: Ciprofloxacin INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE Product Name: Flucloxicillin INN or Proposed INN: FLUCLOXACILLIN SODIUM Trade Name: Fortum INN or Proposed INN: CEFTAZIDIME Product Name: Tobramycin INN or Proposed INN: TOBRAMYCIN SULFATE Trade Name: Meropenem INN or Proposed INN: Meropenem Other descriptive name: MEROPENEM Trade Name: Colistin INN or Proposed INN: COLISTIMETHATE SODIUM	St. Vincent's University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Ireland
2	EUCTR2013-004295-35-AT (EUCTR)	30/04/2014	02/04/2014	Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study	Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study - LCI-OUT	Chronic lung P. Aeruginosa Infection MedDRA version: 16.1;Level: PT;Classification code 10061229;Term: Lung infection;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler Product Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler INN or Proposed INN: aztreonam Other descriptive name: AZTREONAM LYSINE Trade Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel Product Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel INN or Proposed INN: COLISTIMETHATE SODIUM Trade Name: TOBI Product Name: Tobi INN or Proposed INN: TOBRAMYCIN SULFATE	Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Austria
3	EUCTR2011-000443-24-NL (EUCTR)	25/04/2013	06/07/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250		United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
4	EUCTR2011-000443-24-DK (EUCTR)	14/12/2012	22/07/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
5	EUCTR2011-000441-20-NL (EUCTR)	11/09/2012	06/07/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany;United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2011-000441-20-BG (EUCTR)	13/06/2012	03/05/2012	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Serbia;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
7	EUCTR2011-000443-24-SE (EUCTR)	24/05/2012	07/06/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden
8	EUCTR2011-000441-20-IE (EUCTR)	02/05/2012	26/05/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Code: TOBI INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
9	EUCTR2011-000443-24-IT (EUCTR)	10/04/2012	19/03/2012	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin Product Code: NA INN or Proposed INN: AMIKACIN SULFATE	INSMED INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	250		Greece;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Canada;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
10	EUCTR2011-000441-20-DK (EUCTR)	29/03/2012	22/07/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2011-000441-20-BE (EUCTR)	30/01/2012	25/05/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) Product Code: N/A INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Name: TOBI Product Code: N/A INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany
12	EUCTR2011-000443-24-BE (EUCTR)	30/01/2012	25/05/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) Product Code: N/A INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
13	EUCTR2011-000443-24-PL (EUCTR)	20/01/2012	06/10/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
14	EUCTR2011-000443-24-DE (EUCTR)	11/10/2011	30/05/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
15	EUCTR2011-000442-38-BG (EUCTR)	03/10/2011	05/07/2011	Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa	Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	EUCTR2011-000443-24-BG (EUCTR)	03/10/2011	28/07/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
17	EUCTR2011-000441-20-IT (EUCTR)	01/10/2011	08/03/2012	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection/colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) Product Code: NA INN or Proposed INN: AMIKACIN SULFATE Trade Name: Tobi INN or Proposed INN: TOBRAMYCIN	INSMED INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	300		Hungary;Greece;Canada;Spain;Ireland;Denmark;Austria;Bulgaria;Netherlands;United Kingdom;Italy
18	EUCTR2011-000442-38-ES (EUCTR)	21/09/2011	11/11/2011	Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa	Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaESTUDIO ALEATORIZADO, CONTROLADO CON PLACEBO, DOBLE CIEGO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE™ EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Poland;Spain;Ukraine;Australia;Bulgaria;New Zealand;Sweden
19	EUCTR2011-000441-20-DE (EUCTR)	19/09/2011	30/05/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Name: TOBI INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
20	EUCTR2011-000443-24-GR (EUCTR)	09/08/2011	23/06/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	EUCTR2011-000443-24-IE (EUCTR)	05/08/2011	26/05/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
22	EUCTR2011-000441-20-GB (EUCTR)	03/08/2011	24/05/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
23	EUCTR2011-000443-24-GB (EUCTR)	03/08/2011	24/05/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
24	EUCTR2011-000443-24-FR (EUCTR)	28/07/2011	31/05/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) Product Code: NA INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 3	Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
25	EUCTR2011-000443-24-AT (EUCTR)	22/07/2011	27/06/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	EUCTR2011-000441-20-AT (EUCTR)	19/07/2011	21/06/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
27	EUCTR2011-000441-20-GR (EUCTR)	15/07/2011	22/06/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
28	EUCTR2011-000443-24-SK (EUCTR)	04/07/2011	20/02/2014	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	Germany;New Zealand;Sweden;United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands
29	EUCTR2011-000441-20-SK (EUCTR)	04/07/2011	25/11/2014	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
30	EUCTR2011-000443-24-HU (EUCTR)	29/06/2011	11/05/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	EUCTR2011-000441-20-HU (EUCTR)	29/06/2011	20/04/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
32	NCT01755455 (ClinicalTrials.gov)	June 2011	19/12/2012	Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis	Iron Supplementation for the Hypoferremic Anemia of Cystic Fibrosis	Cystic Fibrosis;Anemia, Iron-Deficiency	Drug: Ferrous sulfate 325mg;Drug: Placebo	Dartmouth-Hitchcock Medical Center	NULL	Completed	18 Years	70 Years	All	22	N/A	United States
33	EUCTR2006-006980-22-BE (EUCTR)	27/06/2007	19/07/2007	MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA	MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA	Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin sulfate	Transave, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60		Hungary;Belgium
34	EUCTR2011-000442-38-PL (EUCTR)		01/08/2011	Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa	Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden
35	EUCTR2006-006980-22-PL (EUCTR)		22/08/2007	MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA	MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA	Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Transave, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Hungary;Slovakia;Belgium;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-001785-29-IE
(EUCTR)

15/08/2016

10/05/2016

Study of the effects of combined treatment with the CFTR corrector ivacaftor and IV antibiotics on infection in CF.

Combined Effect of CFTR Modifiers and Intensive Antibiotic Treatment

Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Trade Name: Kalydeco
INN or Proposed INN: IVACAFTOR
Trade Name: Ciprofloxacin
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE
Product Name: Flucloxicillin
INN or Proposed INN: FLUCLOXACILLIN SODIUM
Trade Name: Fortum
INN or Proposed INN: CEFTAZIDIME
Product Name: Tobramycin
INN or Proposed INN: TOBRAMYCIN SULFATE
Trade Name: Meropenem
INN or Proposed INN: Meropenem
Other descriptive name: MEROPENEM
Trade Name: Colistin
INN or Proposed INN: COLISTIMETHATE SODIUM

St. Vincent's University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Ireland

EUCTR2013-004295-35-AT
(EUCTR)

30/04/2014

02/04/2014

Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study

Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study - LCI-OUT

Chronic lung P. Aeruginosa Infection
MedDRA version: 16.1;Level: PT;Classification code 10061229;Term: Lung infection;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Trade Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler
Product Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler
INN or Proposed INN: aztreonam
Other descriptive name: AZTREONAM LYSINE
Trade Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel
Product Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel
INN or Proposed INN: COLISTIMETHATE SODIUM
Trade Name: TOBI
Product Name: Tobi
INN or Proposed INN: TOBRAMYCIN SULFATE

Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Austria

EUCTR2011-000443-24-NL
(EUCTR)

25/04/2013

06/07/2011

Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE

Insmed Incorporated

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden

EUCTR2011-000443-24-DK
(EUCTR)

14/12/2012

22/07/2011

Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

250

United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden

EUCTR2011-000441-20-NL
(EUCTR)

11/09/2012

06/07/2011

Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa

Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa

Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

300

Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany;United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-000441-20-BG
(EUCTR)

13/06/2012

03/05/2012

Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa

Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

300

Serbia;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany

EUCTR2011-000443-24-SE
(EUCTR)

24/05/2012

07/06/2011

Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

250

United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden

EUCTR2011-000441-20-IE
(EUCTR)

02/05/2012

26/05/2011

Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa

Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
Product Code: TOBI
INN or Proposed INN: TOBRAMYCIN

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

300

Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands

EUCTR2011-000443-24-IT
(EUCTR)

10/04/2012

19/03/2012

Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Liposomal Amikacin
Product Code: NA
INN or Proposed INN: AMIKACIN SULFATE

INSMED INCORPORATED

NULL

Not Recruiting

Female: yes
Male: yes

250

Greece;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Canada;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden

EUCTR2011-000441-20-DK
(EUCTR)

29/03/2012

22/07/2011

Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa

Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

300

Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-000441-20-BE
(EUCTR)

30/01/2012

25/05/2011

Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa

Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Liposomal Amikacin (Arikace™)
Product Code: N/A
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
Product Name: TOBI
Product Code: N/A
INN or Proposed INN: TOBRAMYCIN

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany

EUCTR2011-000443-24-BE
(EUCTR)

30/01/2012

25/05/2011

Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Product Name: Liposomal Amikacin (Arikace™)
Product Code: N/A
INN or Proposed INN: AMIKACIN SULFATE

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 3

Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden

EUCTR2011-000443-24-PL
(EUCTR)

20/01/2012

06/10/2011

Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 3

United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden

EUCTR2011-000443-24-DE
(EUCTR)

11/10/2011

30/05/2011

Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

250

Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden

EUCTR2011-000442-38-BG
(EUCTR)

03/10/2011

05/07/2011

Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin Sulfate

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

300

France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-000443-24-BG
(EUCTR)

03/10/2011

28/07/2011

Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

250

Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden

EUCTR2011-000441-20-IT
(EUCTR)

01/10/2011

08/03/2012

Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa

Pseudomonas aeruginosa pulmonary infection/colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Liposomal Amikacin (Arikace™)
Product Code: NA
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: Tobi
INN or Proposed INN: TOBRAMYCIN

INSMED INCORPORATED

NULL

Not Recruiting

Female: yes
Male: yes

300

Hungary;Greece;Canada;Spain;Ireland;Denmark;Austria;Bulgaria;Netherlands;United Kingdom;Italy

EUCTR2011-000442-38-ES
(EUCTR)

21/09/2011

11/11/2011

Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa

Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaESTUDIO ALEATORIZADO, CONTROLADO CON PLACEBO, DOBLE CIEGO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE™ EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA

Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin Sulfate

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

300

France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Poland;Spain;Ukraine;Australia;Bulgaria;New Zealand;Sweden

EUCTR2011-000441-20-DE
(EUCTR)

19/09/2011

30/05/2011

Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa

Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
Product Name: TOBI
INN or Proposed INN: TOBRAMYCIN

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

300

Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany

EUCTR2011-000443-24-GR
(EUCTR)

09/08/2011

23/06/2011

Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

250

United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-000443-24-IE
(EUCTR)

05/08/2011

26/05/2011

Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

250

United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden

EUCTR2011-000441-20-GB
(EUCTR)

03/08/2011

24/05/2011

Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

300

Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands

EUCTR2011-000443-24-GB
(EUCTR)

03/08/2011

24/05/2011

Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 3

United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden

EUCTR2011-000443-24-FR
(EUCTR)

28/07/2011

31/05/2011

Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Liposomal Amikacin (Arikace™)
Product Code: NA
INN or Proposed INN: AMIKACIN SULFATE

Insmed Incorporated

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

Phase 3

Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden

EUCTR2011-000443-24-AT
(EUCTR)

22/07/2011

27/06/2011

Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

250

United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-000441-20-AT
(EUCTR)

19/07/2011

21/06/2011

Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa

Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

300

Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands

EUCTR2011-000441-20-GR
(EUCTR)

15/07/2011

22/06/2011

Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

300

United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands

EUCTR2011-000443-24-SK
(EUCTR)

04/07/2011

20/02/2014

Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 3

Germany;New Zealand;Sweden;United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands

EUCTR2011-000441-20-SK
(EUCTR)

04/07/2011

25/11/2014

Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

300

Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany

EUCTR2011-000443-24-HU
(EUCTR)

29/06/2011

11/05/2011

Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

250

United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-000441-20-HU
(EUCTR)

29/06/2011

20/04/2011

Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

300

Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands

NCT01755455
(ClinicalTrials.gov)

June 2011

19/12/2012

Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis

Iron Supplementation for the Hypoferremic Anemia of Cystic Fibrosis

Cystic Fibrosis;Anemia, Iron-Deficiency

Drug: Ferrous sulfate 325mg;Drug: Placebo

Dartmouth-Hitchcock Medical Center

NULL

Completed

18 Years

70 Years

All

N/A

United States

EUCTR2006-006980-22-BE
(EUCTR)

27/06/2007

19/07/2007

MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA

Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin sulfate

Transave, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Belgium

EUCTR2011-000442-38-PL
(EUCTR)

01/08/2011

Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa

Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin Sulfate

Insmed Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden

EUCTR2006-006980-22-PL
(EUCTR)

22/08/2007

MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA

Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis

Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE

Transave, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Slovakia;Belgium;Poland