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.
| 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 | NCT04553419 (ClinicalTrials.gov) | July 27, 2020 | 11/9/2020 | Antibiotic Treatment Of Staphylococcus Aureus In Stable People With CF | Antibiotic Treatment Of Staphylococcus Aureus In Stable People With CF (ASAP-CF) Clinical Research Protocol | Cystic Fibrosis | Drug: Cephalexin;Drug: Placebo | University of British Columbia | The Hospital for Sick Children | Recruiting | 3 Years | 16 Years | All | 86 | Phase 3 | Canada |
| 2 | EUCTR2019-000955-16-AT (EUCTR) | 28/01/2020 | 07/01/2020 | Characterization of lung concentrations of the antibiotics piperacillin/tazobactam and levofloxacin | Pulmonary pharmacokinetics of piperacillin/tazobactam and levofloxacin in patients with chronic obstructive pulmonary disease or cystic fibrosis: Comparison of epithelial lining fluid, in-vivo microdialysis and tissue biopsy | Pneumonia;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Piperacillin/Tazobactam Kabi - Fresenius Kabi Austria INN or Proposed INN: piperacillin Other descriptive name: PIPERACILLIN INN or Proposed INN: tazobactam Other descriptive name: TAZOBACTAM Trade Name: Levofloxacin Kabi INN or Proposed INN: levofloxacin Other descriptive name: LEVOFLOXACIN HEMIHYDRATE | Medical University of Vienna | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 18 | Phase 4 | Austria | ||
| 3 | NCT03309358 (ClinicalTrials.gov) | September 28, 2017 | 5/10/2017 | A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis | A Multiple-Site, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study to Assess the Safety and Tolerability of Inhaled SNSP113 in Healthy Male Subjects (Part A) and Subjects With Stable Cystic Fibrosis (Part B) | Lung Diseases;Pulmonary Disease;Cystic Fibrosis;Cystic Fibrosis Lung;Cystic Fibrosis Pulmonary Exacerbation;Cystic Fibrosis With Exacerbation;Respiratory Tract Disease;Pulmonary Inflammation;Multi-antibiotic Resistance;Antibiotic Resistant Infection;Lung Infection;Lung Infection Pseudomonal;Lung; Infection, Atypical Mycobacterium;Burkholderia Infections;Burkholderia Cepacia Infection;Lung Inflammation | Drug: Inhaled SNSP113;Drug: Inhaled Placebo | Synspira, Inc. | NULL | Terminated | 18 Years | 50 Years | All | 32 | Phase 1 | United Kingdom |
| 4 | NCT03066453 (ClinicalTrials.gov) | June 13, 2017 | 23/2/2017 | Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic Fibrosis | Evaluation of an Antibiotic Treatment With 14 Days of Intravenous Tobramycin Versus the Same Antibiotic Associated With 5 Days of Intravenous Tobramycin Followed by Tobramycin Aerosol for 9 Days in Cystic Fibrosis. | Cystic Fibrosis | Drug: Tobi Inhalant Product;Drug: Nebcin | University Hospital, Lille | NULL | Recruiting | 8 Years | N/A | All | 97 | Phase 3 | France |
| 5 | NCT02888730 (ClinicalTrials.gov) | February 16, 2017 | 22/6/2016 | Tobramycin Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis Patients | Efficacy of Antibiotic (Tobramycin) Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis Patients: A Multicenter Double-blind Randomized Controlled Trial | Cystic Fibrosis;Rhinosinusitis;Lung Diseases | Drug: Tobramycin nebulized nasally;Drug: Physiologic serum nebulized nasally | Virginie ESCABASSE | Henri Mondor University Hospital | Recruiting | 7 Years | N/A | All | 86 | Phase 3 | France |
| 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 | EUCTR2015-003399-58-DK (EUCTR) | 14/01/2017 | 07/01/2016 | Can antibiotic treatment improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma? | Target-ABC (Targeted AntiBiotics for Chronic pulmonary disease):Can targeted antibiotic therapy improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma? - Target-ABC (Targetted AntiBiotics for Chronic pulmonary disease) | Respiratory tract infection Bacterial infection with Pseudomonas aeruginosaChronic obstructive pulmonary disease (COPD)Non-cystic fibrosis bronchiectasisAsthma MedDRA version: 20.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Ciprofloxacin INN or Proposed INN: ciprofloxacin hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE Product Name: Piperacillin/Tazobactam INN or Proposed INN: piperacillin sodium , tazobactam sodium Other descriptive name: PIPERACILLIN SODIUM | COP:TRIN Region Hovedstaden (Gentofte hospital) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | Denmark | ||
| 7 | EUCTR2016-002832-34-GB (EUCTR) | 11/11/2016 | 03/10/2016 | The use of an inhaled antibiotic called Cayston to treat acute chest infections in people with CF | Aztreonam for inhalation for the treatment of acute exacerbations in cystic fibrosis. An open-label, randomised, cross-over pilot study of AZLI plus intravenous Colistin versus standard dual intravenous therapy. - AZTEC-CF | Cystic fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Cayston INN or Proposed INN: Aztreonam Other descriptive name: Cayston | Liverpool Heart & Chest Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 16 | Phase 4 | United Kingdom | ||
| 8 | EUCTR2016-002578-11-GB (EUCTR) | 16/09/2016 | 09/08/2016 | A trial to determine the safest and most effective antibiotic strategy for infants diagnosed with CF. | The cystic fibrosis (CF) anti-staphylococcal antibiotic prophylaxis trial (CF START); a randomised registry trial to assess the safety and efficacy of flucloxacillin as a longterm prophylaxis agent for infants with CF. - CF START | Cystic fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Flucloxacillin 250mg/5ml Sugar-Free Powder for Oral Solution Product Name: Flucloxacillin Product Code: na INN or Proposed INN: Flucloxacillin | Alder Hey Children's NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 480 | Phase 4 | United Kingdom | ||
| 9 | 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 | |||
| 10 | NCT02781610 (ClinicalTrials.gov) | June 2016 | 12/5/2016 | Standardized Treatment of Pulmonary Exacerbations II | Standardized Treatment of Pulmonary Exacerbations II (STOP2) | Pulmonary Cystic Fibrosis | Drug: Standard of care IV antibiotic(s) | Chris Goss | Cystic Fibrosis Foundation;CF Therapeutics Development Network Coordinating Center;Medical University of South Carolina;University of Washington | Completed | 18 Years | N/A | All | 1048 | Phase 4 | United States;Canada |
| 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 | EUCTR2015-003881-96-IT (EUCTR) | 17/05/2016 | 05/11/2020 | Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with cystic ¿brosis | Pseudomonas aeruginosa eradication in patients with cystic fibrosis: a randomised multicentre study comparing classic treatment protocols with classic treatment together with antibiotic treatment of upper airways. - Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with | cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: COLIMICINA - 1000000 U/4 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE1 FLACONCINO POLVERE + 1 FIALA SOLVENTE 4 ML Product Name: NA Product Code: [NA] INN or Proposed INN: COLISTIMETATO SODICO Other descriptive name: COLISTIN | AZIENDA OSPEDALIERO-UNIVERSITARIA MEYER | NULL | Not Recruiting | Female: yes Male: yes | 112 | Phase 3 | Italy | ||
| 12 | EUCTR2016-000398-19-BE (EUCTR) | 08/03/2016 | 09/02/2016 | Pilot study: pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem in blood and sputum of cystic fibrosis patients. | Pilot study: pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem in blood and sputum of cystic fibrosis patients. - pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem | Cystic fibrosis;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Meropenem Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie INN or Proposed INN: Meropenem Fresenius Kabi Other descriptive name: MEROPENEM TRIHYDRATE Trade Name: Ceftazidim Fresenius Kabi 2000 mg poeder voor oplossing voor injectie of infusie INN or Proposed INN: Ceftazidim Fresenius Kabi Other descriptive name: CEFTAZIDIME PENTAHYDRATE Trade Name: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie Other descriptive name: PIPERACILLIN SODIUM INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie Other descriptive name: TAZOBACTAM SODIUM Trade Name: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie Other descriptive name: PIPERACILLIN SODIUM INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie Other descriptive name: TAZOBACTAM SODIUM | Ghent University | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 4 | Belgium | ||
| 13 | NCT02840136 (ClinicalTrials.gov) | February 2016 | 18/7/2016 | LC-MS/MS Based Method Development for the Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients | Optimisation, Valorisation and Application of UPLC-MS/MS Based Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients - Part 3: Non-blank Sputum Samples for Method Optimisation and Validation | Cystic Fibrosis | Drug: Piperacillin-tazobactam combination product;Drug: Meropenem;Drug: Ceftazidime | University Ghent | King Baudouin Foundation;Belgische Vereniging voor Strijd tegen Mucoviscidose | Suspended | 12 Years | N/A | All | 40 | N/A | Belgium |
| 14 | NCT02489955 (ClinicalTrials.gov) | February 2015 | 18/5/2015 | Antibiotic Nephrotoxicity in Adult Patients With Cystic Fibrosis | Prospective Randomised Trial of 'Area Under the Curve' (AUC) Dosing Strategy for Intravenous Tobramycin Versus Standard Trough Dosing for Pulmonary Exacerbations in Adult Patients With Cystic Fibrosis (CF) | Cystic Fibrosis | Drug: Amikacin;Drug: Tobramycin;Drug: Colomycin | The Leeds Teaching Hospitals NHS Trust | NULL | Recruiting | 18 Years | N/A | Both | N/A | United Kingdom | |
| 15 | NCT02526004 (ClinicalTrials.gov) | January 2015 | 10/8/2015 | Cystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results Stratified | Cystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results Stratified | Cystic Fibrosis | Drug: Ceftazidime;Drug: Tobramycin | University College Cork | Queen's University, Belfast;Paris Descartes University;University of Dundee;University of Washington;University Hospital Heidelberg;Teagasc;Clininfo;GABO:mi;Papworth Hospital;Katholieke Universiteit Leuven;Assistance Publique - Hôpitaux de Paris;European Union | Recruiting | 16 Years | 80 Years | Both | 252 | N/A | Ireland |
| 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 | NCT02372383 (ClinicalTrials.gov) | October 2014 | 20/6/2014 | Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis | Pharmacokinetic Evaluation of Nontuberculous Mycobacterial Antibiotics in Cystic Fibrosis Versus Controls | Cystic Fibrosis | Drug: Ethambutol;Drug: Rifampin;Drug: Azithromycin;Drug: Pancrelipase | University of Colorado, Denver | Cystic Fibrosis Foundation Therapeutics;Colorado Clinical & Translational Sciences Institute | Completed | 16 Years | 45 Years | Both | 32 | N/A | United States |
| 17 | EUCTR2014-001401-41-NL (EUCTR) | 29/07/2014 | 15/05/2014 | Once daily deep inhalation of tobramycin with smart nebulizer more effective to treat small airways disease in cystic fibrosis? | Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis - TAPAS study in patients with CF | Cystic Fibrosis and chronic infection with Pseudomonas aeruginosa;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Bramitob 300mg/4ml Nebuliser Solution | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Netherlands | ||||
| 18 | NCT02113397 (ClinicalTrials.gov) | April 2014 | 9/4/2014 | Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis Lung | Comparative Evaluation of Bacterial Diversity and Richness in CF Lung in Patients Who Use Cycled Every Other Month Tobramycin Inhalation Powder (TOBI™ Podhaler™) Or Continuous Alternating Therapy With Tobramycin Inhalation Powder (TOBI™ Podhaler™) and Inhaled Colistimethate | Cystic Fibrosis | Drug: TOBI™ Podhaler™ 112 mg inhaled twice daily;Drug: Colistimethate 75 mg inhaled two times daily | Dartmouth-Hitchcock Medical Center | Novartis Pharmaceuticals | Terminated | 12 Years | 75 Years | All | 1 | United States | |
| 19 | EUCTR2013-004488-30-NL (EUCTR) | 31/01/2014 | 11/12/2013 | Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK) | Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK) - TAPAS-PK study in patients with CF | Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Bramitob INN or Proposed INN: TOBRAMYCIN Other descriptive name: TOBRAMYCIN | Haga Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 20 | NCT01695343 (ClinicalTrials.gov) | December 2012 | 25/9/2012 | Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment | A Phase 2, Randomized, Double-blind, Placebo-controlled, Repeat-dose Study of KB001-A in Subjects With Cystic Fibrosis Infected With Pseudomonas Aeruginosa | Cystic Fibrosis | Biological: KB001-A;Drug: Placebo Comparator | KaloBios Pharmaceuticals | NULL | Completed | 12 Years | 50 Years | Both | 182 | Phase 2 | United States;Australia;Israel;New Zealand |
| 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 | NCT01641822 (ClinicalTrials.gov) | December 2012 | 13/7/2012 | Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas Aeruginosa Infection in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: AZLI;Drug: Placebo to match AZLI;Drug: Tobramycin inhalation solution | Gilead Sciences | NULL | Completed | 6 Years | N/A | All | 107 | Phase 3 | United States |
| 22 | NCT01667094 (ClinicalTrials.gov) | September 2012 | 13/8/2012 | A Study Comparing Continuous Infusion Antibiotics to Standard Treatment for Lung Infections in Cystic Fibrosis | Continuous-infusion Anti-pseudomonal ß-lactams for the Treatment of Acute, Infective Pulmonary Exacerbations in Cystic Fibrosis | Cystic Fibrosis | Drug: Intermittent, short infusion Ceftazidime;Drug: Continuous infusion Ceftazidime;Drug: Intermittent, short infusion Meropenem;Drug: Continuous infusion Meropenem;Drug: Intermittent, short infusion Ticarcillin-clavulanate;Drug: Continuous infusion Ticarcillin-clavulanate;Drug: Intermittent, short infusion Cefepime;Drug: Continuous infusion Cefepime;Drug: Continuous infusion Piperacillin tazobactam;Drug: Intermittent, short infusion Piperacillin tazobactam | The Alfred | NULL | Active, not recruiting | 18 Years | N/A | All | 50 | Phase 4 | Australia |
| 23 | NCT02295566 (ClinicalTrials.gov) | May 2011 | 20/8/2014 | RATNO, Reducing Antibiotic Tolerance Using Nitric Oxide in CF - a Phase 2 Pilot Study | RATNO (Reducing Antibiotic Tolerance Using NO) Reducing Antibiotic Tolerance Using Low Dose Nitric Oxide in Cystic Fibrosis - a Phase 2 Pilot Study | Cystic Fibrosis | Drug: Nitric Oxide;Drug: Control | University Hospital Southampton NHS Foundation Trust. | University of Southampton | Completed | 12 Years | N/A | Both | 12 | Phase 2 | United Kingdom |
| 24 | NCT01314716 (ClinicalTrials.gov) | April 2011 | 11/3/2011 | Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis | A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2) | Bronchiectasis | Drug: AZLI;Drug: Placebo | Gilead Sciences | NULL | Completed | 18 Years | N/A | All | 274 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom |
| 25 | NCT01313624 (ClinicalTrials.gov) | April 2011 | 10/3/2011 | Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis | A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection | Bronchiectasis | Drug: AZLI;Drug: Placebo | Gilead Sciences | NULL | Completed | 18 Years | N/A | All | 266 | Phase 3 | United States;Australia;Canada |
| 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 | EUCTR2010-023529-39-GB (EUCTR) | 18/02/2011 | 31/12/2010 | Reducing antibiotic tolerance using low dose nitric oxide in cystic fibrosis – a phase 2 pilot study - RATNO (Reducing Antibiotic Tolerance using Nitric Oxide in CF) v 1.0 | Reducing antibiotic tolerance using low dose nitric oxide in cystic fibrosis – a phase 2 pilot study - RATNO (Reducing Antibiotic Tolerance using Nitric Oxide in CF) v 1.0 | Cystic Fibrosis | Trade Name: INOmax 400ppm mol/mol inhalation gas Product Name: Nitric Oxide Product Code: NO | Southampton University Hopsitals NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | United Kingdom | |||
| 27 | NCT01090908 (ClinicalTrials.gov) | September 2010 | 11/3/2010 | Evaluation of Ciprofloxacin for Inhalation to Cystic Fibrosis Patients With P. Aeruginosa | A Multi-Center, Open Label Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Ciprofloxacin For Inhalation (CFI) Given Daily For 14 Days To Stable Cystic Fibrosis Patients Ages 6 To 17 With Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: Antibiotic | Aradigm Corporation | NULL | Withdrawn | 6 Years | 18 Years | Both | 0 | N/A | NULL |
| 28 | EUCTR2007-004277-26-AT (EUCTR) | 21/01/2010 | 21/04/2009 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Cayston Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 29 | NCT01044719 (ClinicalTrials.gov) | January 2010 | 14/12/2009 | Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis | What Duration of Intravenous Antibiotic Therapy Should be Used in the Treatment of Infective Exacerbations of Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: Ceftazidime;Drug: Tobramycin;Drug: Meropenem | Imperial College London | NULL | Not yet recruiting | 16 Years | N/A | Both | 240 | Phase 4 | United Kingdom |
| 30 | EUCTR2009-014042-28-GB (EUCTR) | 16/10/2009 | 14/10/2010 | What duration of intravenous antibiotic therapy should be used in the treatment of infective exacerbations of cystic fibrosis in patients chronically colonised with Pseudomonas aeruginosa? - Duration of antibiotics in infective exacerbations of cystic fibrosis | What duration of intravenous antibiotic therapy should be used in the treatment of infective exacerbations of cystic fibrosis in patients chronically colonised with Pseudomonas aeruginosa? - Duration of antibiotics in infective exacerbations of cystic fibrosis | Cystic Fibrosis | Trade Name: Meropenem Product Name: Meropenem INN or Proposed INN: Meropenem Trade Name: Ceftazidime Product Name: Ceftazidime INN or Proposed INN: Ceftazidime Trade Name: Tobramycin Product Name: Tobramycin INN or Proposed INN: Tobramycin | Imperial College, London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | 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 |
| 31 | EUCTR2007-004277-26-GB (EUCTR) | 12/03/2009 | 08/02/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Cayston Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 32 | EUCTR2007-004277-26-PT (EUCTR) | 12/12/2008 | 17/10/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 33 | EUCTR2007-004277-26-DE (EUCTR) | 14/10/2008 | 29/05/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Cayston Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 34 | EUCTR2007-004277-26-ES (EUCTR) | 25/08/2008 | 24/01/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. Pacientes adultos y pediátricos con fibrosis quística (FQ) con infección pulmonar por Pseudomonas aeruginosa (PA). MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 35 | NCT00757237 (ClinicalTrials.gov) | August 2008 | 22/9/2008 | Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam for Inhalation Solution (AZLI) Versus Tobramycin Inhalation Solution (TIS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects With Cystic Fibrosis Followed by an Open-Label, Single Arm Extension (European Union [EU] Only) | Cystic Fibrosis | Drug: Aztreonam for Inhalation Solution (AZLI);Drug: Tobramycin Inhalation Solution (TIS) | Gilead Sciences | Chiltern International Inc.;ClinPhone, Inc.;Covance | Completed | 6 Years | N/A | All | 274 | Phase 3 | United States;Austria;Belgium;Denmark;France;Germany;Ireland;Italy;Netherlands;Portugal;Spain;Switzerland;United Kingdom;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 |
| 36 | EUCTR2007-004277-26-IE (EUCTR) | 19/06/2008 | 27/02/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 37 | EUCTR2007-004277-26-NL (EUCTR) | 10/06/2008 | 29/05/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open-Label, Single Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open-Label, Single Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 38 | EUCTR2007-004277-26-FR (EUCTR) | 30/04/2008 | 21/01/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 39 | EUCTR2007-004277-26-BE (EUCTR) | 29/04/2008 | 20/12/2007 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 273 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 40 | EUCTR2007-004277-26-IT (EUCTR) | 23/04/2008 | 17/06/2008 | An open-label, randomised, phase 3 trial to evaluate the efficacy and safety of Aztreonan LYsine for inhalation versus Tobramycin nebuliser solution in an intermittent aerosolized antibiotic regimen in patients with cystic fibrosis. - ND | An open-label, randomised, phase 3 trial to evaluate the efficacy and safety of Aztreonan LYsine for inhalation versus Tobramycin nebuliser solution in an intermittent aerosolized antibiotic regimen in patients with cystic fibrosis. - ND | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: aztreonan lysine Product Code: AZLI INN or Proposed INN: Aztreonam Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML INN or Proposed INN: Tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 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 |
| 41 | EUCTR2008-006502-42-IT (EUCTR) | 22/04/2008 | 07/04/2010 | Early antibiotic treatment in pseudomonas aeruginosa eradication in cystic fibrosis patients: a randomised policentric study on two different protocols - #FFC17/2007 | Early antibiotic treatment in pseudomonas aeruginosa eradication in cystic fibrosis patients: a randomised policentric study on two different protocols - #FFC17/2007 | Cystic fibrosis MedDRA version: 9.1;Level: SOC;Classification code 10038738 | Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML INN or Proposed INN: Tobramycin INN or Proposed INN: Colistin INN or Proposed INN: Ciprofloxacin | AZIENDA OSPEDALIERA MEYER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 42 | EUCTR2007-004277-26-DK (EUCTR) | 16/04/2008 | 12/03/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 43 | NCT00104520 (ClinicalTrials.gov) | February 2005 | 1/3/2005 | Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa | A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2) | Cystic Fibrosis | Drug: AZLI 75 mg two times a day (BID)/three times a day (TID);Drug: Placebo two times a day (BID)/three times a day (TID) | Gilead Sciences | NULL | Completed | 6 Years | N/A | All | 211 | Phase 3 | United States |
| 44 | NCT00823238 (ClinicalTrials.gov) | July 2004 | 29/12/2008 | Comparison of Antibiotics for Pseudomonas in Early CF | Comparison of Antibiotics for Pseudomonas in Early CF | Cystic Fibrosis | Drug: ceftazidime and tobramycin;Drug: inhaled tobramycin | University of North Carolina, Chapel Hill | Cystic Fibrosis Foundation Therapeutics | Completed | 3 Months | 16 Years | Both | 21 | Phase 1 | United States |
| 45 | NCT00205634 (ClinicalTrials.gov) | December 2000 | 12/9/2005 | Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis | Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Biaxin ( clarithromycin) | Wake Forest University | Abbott | Completed | 6 Years | 50 Years | All | 50 | Phase 2 | United States |
| 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 |
| 46 | EUCTR2007-004277-26-Outside-EU/EEA (EUCTR) | 02/02/2015 | A Clinical Trial to Evaluate the Efficacy and Safety of the drug Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) in comparison to the drug Tobramycin Nebulizer Solution (TNS) in patients with Cystic Fibrosis. | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension. | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston INN or Proposed INN: AZTREONAM Trade Name: TOBI INN or Proposed INN: TOBRAMYCIN Other descriptive name: TOBRAMYCIN | Gilead Sciences Inc | NULL | NA | Female: yes Male: yes | 268 | Phase 3 | United States | |||
| 47 | EUCTR2015-000398-11-Outside-EU/EEA (EUCTR) | 03/02/2015 | A Clinical Trial to Assess the Safety and Efficacy of an Alternating Therapy of Antibiotics with the Drug Aztreonam for Inhalation Solution (AZLI) for the Treatment of Lung Infection by the bacteria Pseudomonas aeruginosa in Patients with Cystic Fibrosis. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas aeruginosa Infection in Subjects with Cystic Fibrosis | Cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston INN or Proposed INN: AZTREONAM Trade Name: TOBI® INN or Proposed INN: TOBRAMYCIN Other descriptive name: TOBRAMYCIN | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 250 | Phase 3 | United States | |||
| 48 | EUCTR2014-003882-10-FR (EUCTR) | 29/07/2015 | Evaluation of the efficacy of antibiotic treatments associated with the Nebcine® as intravenous injection only and / or monitoring of aerosols of Tobi® in order to optimize the therapeutic management of exacerbations in patients with cystic fibrosis . | Evaluation of the effectiveness of a treatment involving one (or several ) antibiotic (s) with 14-day tobramycin ( Nebcine® ) by intravenous injection versus the same antibiotic treatment (s ) associated with only 5 days of tobramycin ( Nebcine® ) by intravenous injection followed tobramycin aerosol ( Tobi® ) for 9 days in the context of cystic fibrosis | mucoviscidosis or cystic fibrosis MedDRA version: 18.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: NEBCINE Product Name: NEBCINE Other descriptive name: TOBRAMYCIN Trade Name: NEBCINE Product Name: NEBCINE Other descriptive name: TOBRAMYCIN Trade Name: NEBCINE Product Name: NEBCINE Other descriptive name: TOBRAMYCIN Trade Name: NEBCINE Product Name: NEBCINE Other descriptive name: TOBRAMYCIN Trade Name: TOBI Product Name: TOBI Other descriptive name: TOBRAMYCIN | CHRU de Lille | NULL | NA | Female: yes Male: yes | Phase 2 | France |