Saline ( DrugBank: - )
6 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 6 | パーキンソン病 | 15 |
| 13 | 多発性硬化症／視神経脊髄炎 | 9 |
| 53 | シェーグレン症候群 | 4 |
| 67 | 多発性嚢胞腎 | 3 |
| 168 | エーラス・ダンロス症候群 | 1 |
| 299 | 嚢胞性線維症 | 53 |
6. パーキンソン病
臨床試験数 : 2,307 / 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
| 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 | NCT05435755 (ClinicalTrials.gov) | December 2, 2022 | 15/3/2022 | Precise Transplantation of hAESCs Into the Ventricle for Parkinson's Disease. | The Precise Transplantation of Human Amniotic Epithelial Stem Cells Into the Ventricle Through Surgical Robot in the Treatment of Parkinson's Disease. | Parkinson's Disease | Biological: hAESCs treatment;Biological: placebo (saline) | Shanghai East Hospital | Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China | Not yet recruiting | 30 Years | 70 Years | All | 12 | Early Phase 1 | China |
| 2 | NCT05197439 (ClinicalTrials.gov) | December 1, 2022 | 5/1/2022 | Dexmedetomidine Prevents Postoperative Delirium After Deep Brain Stimulation in Patients With Parkinson's Disease | Effect of Dexmedetomidine on Postoperative Delirium in Elderly Patients With Parkinson's Disease Undergoing Deep Brain Stimulation: a Randomized Controlled Trial | Dexmedetomidine;Postoperative Delirium;Deep Brain Stimulation | Drug: Dexmedetomidine;Drug: 0.9% saline | Beijing Tiantan Hospital | NULL | Not yet recruiting | 60 Years | N/A | All | 192 | N/A | China |
| 3 | NCT04944017 (ClinicalTrials.gov) | November 23, 2021 | 22/6/2021 | Ketamine for the Treatment of Depression in Parkinson's Disease | Ketamine for the Treatment of Depression in Parkinson's Disease (KET-PD) | Parkinson's Disease;Depression | Drug: Ketamine Infusion;Other: Placebo - Saline Infusion | Yale University | Fox (Michael J.) Foundation for Parkinson's Research | Recruiting | 40 Years | 80 Years | All | 56 | Phase 2 | United States |
| 4 | NCT04687878 (ClinicalTrials.gov) | January 1, 2020 | 28/12/2020 | The Effect of Intranasal Insulin on Motor and Non-motor Symptoms in Parkinson's Disease Patients | Evaluating the Effect of Intranasal Insulin Administration on Motor and Non-motor Symptoms in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical Trial | Parkinson Disease | Drug: Insulin;Drug: Normal saline | dr.dargahi | NULL | Recruiting | 17 Years | N/A | All | 40 | Phase 2 | Iran, Islamic Republic of |
| 5 | NCT04202757 (ClinicalTrials.gov) | September 14, 2018 | 21/9/2018 | Intravenous Plasma Treatment for Parkinson's Disease | Intravenous Young Fresh Frozen Plasma (yFFP) Investigational Treatment for Parkinson's Disease - Randomized Controlled Study | Idiopathic Parkinson Disease | Biological: [21CFR640.30] Plasma from 18 - 25 year old volunteer donors;Other: Saline | The Neurology Center | Carolina Longevity Institute | Completed | 45 Years | 90 Years | All | 18 | Phase 4 | United States |
| 6 | ChiCTR2000037957 | 2016-12-01 | 2020-09-07 | Clinical study of dexmedetomidine on deep brain stimulation in middle-aged and elderly patients with Parkinson's disease | Clinical study of dexmedetomidine on deep brain stimulation in middle-aged and elderly patients with Parkinson's disease | Deep brain stimulation in patients with Parkinson's disease | Experimental group:conscious sedation with dexmedetomidine;control group:Pump in normal saline; | Shanghai Jing'an District Central Hospital | NULL | Completed | 45 | 75 | Both | Experimental group:27;control group:9; | China | |
| 7 | NCT02018406 (ClinicalTrials.gov) | December 2013 | 30/10/2013 | Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain Injury | Neurological Diseases;Ischemic Stroke;Hemorrhagic Stroke;Cerebral Palsy;Atypical Parkinson Disease | Drug: Combination injection of EPO and G-CSF;Drug: Injection of normal saline | Yonsei University | NULL | Active, not recruiting | 20 Years | N/A | All | 16 | Phase 1/Phase 2 | Korea, Republic of | |
| 8 | JPRN-UMIN000017695 | 2013/01/01 | 27/05/2015 | Oxybuprocaine for apraxia of lid opening in Parkinson's disease | Oxybuprocaine for apraxia of lid opening in Parkinson's disease - Oxybuprocain for ALO | apraxia of lid opening in Parkinson's disease | Arm 1 intervention consisted of 4%oxybuprocaine eye drop treatment, washout for 24 hours or more, and a saline eye drop treatment Arm 2 intervention consisted of saline eye drop treatment, a washout period, and an oxybuprocaine treatment | Utano National Hospital, National Hospital Organization | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 10 | Not selected | Japan |
| 9 | JPRN-UMIN000009099 | 2012/10/01 | 12/10/2012 | The effect of lidocaine injection into the external oblique in Parkinson's disease patients with upper camptorcormia | The effect of lidocaine injection into the external oblique in Parkinson's disease patients with upper camptorcormia - The effect of lidocaine injection in Parkinson's disease patients with camptorcormia | Parkinson's disease | lidocaine injection into the external oblique normal saline injection into the external oblique | Parkinson's disease and Movement Disorder Center | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 10 | Not applicable | Japan |
| 10 | NCT02419313 (ClinicalTrials.gov) | August 2012 | 27/1/2014 | Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Tremor: A Customized Approach | Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Disease Tremor: A Customized Approach | Parkinson;Tremor | Drug: incobotulinumtoxinA;Drug: Saline | Yale University | NULL | Completed | 18 Years | N/A | All | 33 | Phase 2 | United States |
| 11 | NCT01398748 (ClinicalTrials.gov) | July 2012 | 19/7/2011 | Intranasal Glutathione in Parkinson's Disease | A Phase 1 Study of Intranasal Reduced Glutathione in Parkinson's Disease | Parkinson's Disease (PD) | Drug: Intranasal glutathione - (in)GSH;Drug: Saline Intranasal Delivery | Bastyr University | National Center for Complementary and Integrative Health (NCCIH) | Completed | 21 Years | 100 Years | All | 34 | Phase 1 | United States |
| 12 | NCT01313819 (ClinicalTrials.gov) | April 2011 | 10/3/2011 | The Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy | A Double Blind, Placebo-controlled Study for the Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy | Parkinson`s Disease;Freezing of Gait | Drug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj | Seoul National University Hospital | NULL | Recruiting | 30 Years | 80 Years | Both | 20 | Phase 4 | Korea, Republic of |
| 13 | NCT01229332 (ClinicalTrials.gov) | January 2011 | 3/10/2010 | A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients | A Phase I/II, Single-center, Randomized, Cross-over, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Administration of Subcutaneous Continuously-delivered Carbidopa Solution (ND0611) on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: Saline;Drug: Carbidopa | NeuroDerm Ltd. | NULL | Completed | 30 Years | N/A | Both | 24 | Phase 1/Phase 2 | Israel |
| 14 | NCT00608231 (ClinicalTrials.gov) | January 2008 | 7/1/2008 | Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation | Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation | Parkinson's Disease;Essential Tremor;Dystonia | Drug: Dexmedetomidine Hydrochloride Infusion;Drug: Normal Saline | Vanderbilt University | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 2/Phase 3 | United States |
| 15 | NCT00623363 (ClinicalTrials.gov) | April 2007 | 2/1/2008 | Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease | Parkinson's Disease | Drug: piclozotan;Drug: 0.9% sodium chloride (normal saline) | Asubio Pharmaceuticals, Inc. | NULL | Completed | 40 Years | 85 Years | Both | 27 | Phase 2 | United States;Guatemala;Romania |
13. 多発性硬化症／視神経脊髄炎
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| 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 | NCT04979650 (ClinicalTrials.gov) | May 22, 2021 | 2/7/2021 | Corticosteroid Effects on Asymptomatic Gadolinium-enhancing Lesions in Multiple Sclerosis | Corticosteroid Pulse Therapy Effects on MRI Asymptomatic Gadolinium-enhancing Lesions Conversion to a Non-enhancing Black Hole With or Without Treatment in MS Clinic of Booalisina Hospital Sari 2021-2023 | Multiple Sclerosis, Relapsing-Remitting;Magnetic Resonance Imaging;Methylprednisolone | Drug: Methylprednisolone succinate;Drug: Normal saline | Mazandaran University of Medical Sciences | NULL | Enrolling by invitation | 18 Years | 55 Years | All | 104 | Phase 2 | Iran, Islamic Republic of |
| 2 | NCT03355365 (ClinicalTrials.gov) | September 21, 2018 | 14/11/2017 | Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis | Autologous, Bone Marrow-Derived Mesenchymal Stem Cell-Derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo; Administered Intrathecally | Multiple Sclerosis | Biological: Intrathecal MSC-NP injection;Other: Intrathecal saline injection | Tisch Multiple Sclerosis Research Center of New York | NULL | Active, not recruiting | 18 Years | 65 Years | All | 50 | Phase 2 | United States |
| 3 | NCT02228213 (ClinicalTrials.gov) | October 2014 | 21/8/2014 | Safety and Efficacy Study of MIS416 to Treat Secondary Progressive Multiple Sclerosis | A Phase 2B Randomised, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of MIS416 in the Treatment of Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Biological: MIS416;Drug: Saline | Innate Immunotherapeutics | INC Research | Completed | 18 Years | 70 Years | All | 93 | Phase 2 | Australia;New Zealand |
| 4 | NCT01911377 (ClinicalTrials.gov) | October 2013 | 25/7/2013 | Botulinum Toxin Type A for Treating Allodynic Pain in SCI and MS | The Efficacy of Botulinum Toxin Type A in the Treatment of Allodynic-Type Neuropathic Pain in People With Spinal Cord Injury or Multiple Sclerosis | Neuropathic Pain;Allodynia | Drug: Botulinum Toxin Type A;Drug: Normal Saline for Injection | University of Manitoba | Allergan | Terminated | 18 Years | 70 Years | Both | 12 | Phase 2 | Canada |
| 5 | NCT01600716 (ClinicalTrials.gov) | June 13, 2012 | 15/5/2012 | Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS) | Urinary Incontinence;Multiple Sclerosis;Neurogenic Bladder | Biological: OnabotulinumtoxinA;Drug: Placebo (Normal Saline) | Allergan | NULL | Completed | 18 Years | N/A | All | 144 | Phase 3 | United States;Belgium;Canada;Czechia;France;Poland;Portugal;Russian Federation;Czech Republic | |
| 6 | NCT01435993 (ClinicalTrials.gov) | September 8, 2011 | 25/8/2011 | Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis | A Randomized, Single Blind, Placebo-controlled, Single Ascending Dose/Repeat Dose Cohort Study to Assess Safety, Tolerability, Pharmacokinetics and Immunogenicity of GSK1223249 in Patients With Relapsing Forms of Multiple Sclerosis. | Multiple Sclerosis, Relapsing-Remitting | Drug: GSK1223249;Other: Saline placebo | GlaxoSmithKline | NULL | Terminated | 18 Years | 60 Years | All | 3 | Phase 1 | Italy;Norway;Germany |
| 7 | NCT01212094 (ClinicalTrials.gov) | September 2010 | 29/9/2010 | Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe) | Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe) | Multiple Sclerosis | Drug: Rituximab;Other: normal saline | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Terminated | 18 Years | 65 Years | All | 44 | Phase 1/Phase 2 | United States |
| 8 | NCT00986960 (ClinicalTrials.gov) | December 2009 | 29/9/2009 | Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS) | Effect of Pulsed ACTH add-on Therapy to Weekly Avonex on Remyelination and Neuroregeneration in Patients With Relapsing Remitting Multiple Sclerosis. A 1-year Placebo-controlled, Double-blinded, Randomized Follow-up Study | Multiple Sclerosis | Drug: repository corticotropin injection;Drug: Saline | University at Buffalo | NULL | Terminated | 18 Years | 65 Years | All | 3 | Phase 2 | United States |
| 9 | NCT01091727 (ClinicalTrials.gov) | October 2006 | 22/3/2010 | Intravesical Injection of Botulinum Toxin A Versus Saline for Neurogenic Detrusor Overactivity | Prospective Randomized Double-blind Trial of Intravesical Injection of Botulinum Toxin A Versus Saline for Neurogenic Detrusor Overactivity and Urinary Incontinence Related to Spinal Cord Injury or Multiple Sclerosis | Neurogenic Detrusor Overactivity | Drug: Botulinum toxin A | Sunnybrook Health Sciences Centre | ethica Clinical Research Inc. | Completed | 18 Years | 75 Years | Both | 57 | Phase 3 | Canada |
53. シェーグレン症候群
臨床試験数 : 305 / 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188
| 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 | ChiCTR2100052314 | 2021-11-01 | 2021-10-24 | Effect of triamcinolone acetonide for parotid gland lavage on the salivary secretion of patients with Sjogren's syndrome | Effect of triamcinolone acetonide irrigation through parotid duct for parotid gland salivary secretion of patients with Sjogren's syndrome | Sjogren syndrome | Experimental Group:Perfusing parotid gland with triamcinolone acetonide injection through parotid duct;Control Group:The parotid gland was perfused with normal saline through parotid duct; | Affiliated Stomatological Hospital of Nanjing Medical University | NULL | Pending | 20 | 80 | Both | Experimental Group:27;Control Group:27; | Phase 4 | China |
| 2 | NCT02112019 (ClinicalTrials.gov) | June 2014 | 8/4/2014 | Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome | Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome; A Randomised Controlled Pilot Study | Sjögren's Syndrome | Procedure: Sialoendoscopy;Drug: saline;Drug: hydrocortisone | Derk Jan Jager | NULL | Active, not recruiting | 18 Years | 70 Years | All | 50 | N/A | Netherlands |
| 3 | NCT01357447 (ClinicalTrials.gov) | May 2011 | 18/5/2011 | Pulmozyme for Sjogren's Associated Cough | A Double-blind, Placebo-controlled Cross-over Trial of Pulmozyme for Sjogren's Associated Cough | Sjogren's Syndrome;Cough | Drug: Dornase alfa;Drug: Saline | UConn Health | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 1 | United States |
| 4 | EUCTR2007-001708-19-FR (EUCTR) | 23/08/2007 | 06/08/2007 | A 3-month study of the efficacy and safety of SVS20 in patients with bilateral moderate dry eye syndrome : A prospective, double-masked, randomised, controlled, parallel-group, 3-arm, multicentre, phase III trial. | A 3-month study of the efficacy and safety of SVS20 in patients with bilateral moderate dry eye syndrome : A prospective, double-masked, randomised, controlled, parallel-group, 3-arm, multicentre, phase III trial. | treatment on bilateral moderate dry eye syndrome due to Sjögren's syndrome or diagnosed as a primary syndrome MedDRA version: 9.1;Level: LLT;Classification code 10013774;Term: Dry eye | Product Name: SVS20 Product Code: SVS20 INN or Proposed INN: sodium hyaluronate Trade Name: Lacryvisc INN or Proposed INN: carbomer 974P Product Name: SALINE INN or Proposed INN: sodium chloride | TRB CHEMEDICA INTERNATIONAL SA | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United Kingdom |
67. 多発性嚢胞腎
臨床試験数 : 221 / 薬物数 : 212 - (DrugBank : 55) / 標的遺伝子数 : 40 - 標的パスウェイ数 : 151
| 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 | NCT02127437 (ClinicalTrials.gov) | September 19, 2014 | 2/4/2014 | Lanreotide In Polycystic Kidney Disease Study | Lanreotide In Polycystic Kidney Disease Study | Autosomal Dominant Polycystic Kidney Disease (ADPKD | Drug: Lanreotide;Drug: saline | Assistance Publique - Hôpitaux de Paris | IPSEN pharmaceutical company, Boulogne-Billancourt, France | Completed | 18 Years | N/A | All | 159 | Phase 3 | France |
| 2 | NCT01377246 (ClinicalTrials.gov) | May 2011 | 20/6/2011 | Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe Renal Insufficiency | A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED CLINICAL TRIAL TO ASSESS THE EFFECTS OF LONG-ACTING SOMATOSTATIN (OCTREOTIDE LAR) THERAPY ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE TO SEVERE RENAL INSUFFICIENCY | Autosomal Dominant Polycystic Kidney Disease | Drug: Octreotide-LAR;Other: Saline solution. | Mario Negri Institute for Pharmacological Research | NULL | Completed | 18 Years | 75 Years | All | 100 | Phase 3 | Italy |
| 3 | NCT00309283 (ClinicalTrials.gov) | April 2006 | 30/3/2006 | Somatostatin in Polycystic Kidney: a Long-term Three Year Follow up Study | Effect of a Long-acting Somatostatin on Disease Progression in Nephropathy Due to Autosomal Dominant Polycystic Kidney Disease: a Long-term Three Year Follow up Study | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Drug: Long-acting somatostatin;Other: Saline solution | Mario Negri Institute for Pharmacological Research | NULL | Completed | 18 Years | 75 Years | Both | 78 | Phase 3 | Italy |
168. エーラス・ダンロス症候群
臨床試験数 : 13 / 薬物数 : 21 - (DrugBank : 11) / 標的遺伝子数 : 11 - 標的パスウェイ数 : 103
| 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 | NCT01446783 (ClinicalTrials.gov) | September 2011 | 27/9/2011 | IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients | IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients | Ehlers-Danlos Syndrome, Classic | Drug: mecasermin;Drug: Saline | Bispebjerg Hospital | NULL | Completed | 18 Years | N/A | Both | 15 | N/A | Denmark |
299. 嚢胞性線維症
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
| 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 | EUCTR2015-004143-39-IT (EUCTR) | 19/12/2018 | 20/09/2018 | Saline hypertonic in preschoolers and lung structure as measured by computed tomography. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;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] | Product Name: Hypertonic saline INN or Proposed INN: SODIUM CHLORIDE 7% Other descriptive name: SODIUM CHLORIDE 7% Product Name: Isotonic saline INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% | Erasmus MC | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Spain;Belgium;Denmark;Australia;Netherlands;Italy | ||
| 2 | NCT03375047 (ClinicalTrials.gov) | May 10, 2018 | 7/9/2017 | Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis | A Phase 1/2, Randomized, Double-Blinded, Placebo-Controlled, Combined Single and Multiple Ascending Dose Study Evaluating the Safety, Tolerability, and Biological Activity of MRT5005 Administered by Nebulization to Adult Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: MRT5005;Drug: Normal saline | Translate Bio, Inc. | NULL | Recruiting | 18 Years | N/A | All | 40 | Phase 1/Phase 2 | United States |
| 3 | NCT03460704 (ClinicalTrials.gov) | January 29, 2018 | 14/2/2018 | Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium (PROMIS II) | A Double-blind, Placebo-controlled, Multi-centre, Clinical Trial to Investigate the Efficacy and Safety of 12 Months of Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With Pseudomonas Aeruginosa (P. Aeruginosa) | Non Cystic Fibrosis Bronchiectasis | Drug: Colistimethate sodium;Drug: Saline Solution | Zambon SpA | NULL | Completed | 18 Years | 90 Years | All | 287 | Phase 3 | United States;Argentina;Australia;Canada;France;Germany;Greece;Israel;Italy;New Zealand;Poland;Portugal |
| 4 | NCT03078088 (ClinicalTrials.gov) | June 15, 2017 | 1/3/2017 | Airway Alkalinization and Nasal Colonization | Airway Alkalinization and Nasal Colonization | Healthy Subjects;Cystic Fibrosis | Drug: Tham;Drug: Saline | Lakshmi Durairaj | NULL | Completed | 16 Years | N/A | All | 32 | Phase 1 | United States |
| 5 | NCT03093974 (ClinicalTrials.gov) | June 6, 2017 | 9/3/2017 | Long Term Efficacy and Safety of Inhaled Colistimethate Sodium in Bronchiectasis Subjects With Chronic Pseudomonas Aeruginosa Infection. | A Double-blind, Placebo-controlled, Multi-centre, Clinical Trial to Investigate the Efficacy and Safety of 12 Months of Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With Pseudomonas Aeruginosa (P. Aeruginosa) | Non Cystic Fibrosis Bronchiectasis | Drug: Colistimethate Sodium;Drug: Saline Solution | Zambon SpA | NULL | Completed | 18 Years | N/A | All | 377 | Phase 3 | Australia;Belgium;Germany;Greece;Israel;Italy;Netherlands;New Zealand;Portugal;Spain;Switzerland;United Kingdom |
| 6 | EUCTR2015-004143-39-ES (EUCTR) | 19/04/2017 | 31/03/2017 | Saline hypertonic in preschoolers and lung structure as measured by computed tomography. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study | Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 19.1;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] | Product Name: Hypertonic saline INN or Proposed INN: HYPERTONIC SALINE Other descriptive name: SALINE Product Name: Isotonic saline INN or Proposed INN: ISOTONIC SALINE Other descriptive name: STERILE PYROGEN-FREE ISOTONIC NACL SOLUTE (0.9% W / V) | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Spain;Denmark;Australia;Netherlands | ||
| 7 | EUCTR2015-004143-39-DK (EUCTR) | 14/02/2017 | 25/10/2016 | Saline Hypertonic in Preschoolers with cystic fibrosis and lung structure asmeasured by computedtomography (CT). SHIP-CT study. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7%hypertonic saline versus0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6years of age inparallel with the North American SHIP clinical trial - Ship-CT study | Cystic fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Hypertonic saline INN or Proposed INN: sodium chloride 7% Other descriptive name: SODIUM CHLORIDE 7% Product Name: Isotonic saline 0.9% INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% | Erasmus MC | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Spain;Belgium;Australia;Denmark;Netherlands;Italy | ||
| 8 | EUCTR2015-004841-13-CZ (EUCTR) | 04/01/2017 | 10/08/2016 | A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi | 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] - Respiratory Tract Diseases [C08] | Product Code: VX-371 in hypertonic saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Ivacaftor INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic saline INN or Proposed INN: 4.2% NaCl/inhalation solution | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | France;United States;Czech Republic;Ireland;United Kingdom | ||
| 9 | NCT02947126 (ClinicalTrials.gov) | January 2017 | 25/10/2016 | Multilevel Models of Therapeutic Response in the Lungs | Multilevel Models of Therapeutic Response in the Lungs | Cystic Fibrosis | Drug: Hypertonic Saline;Drug: Isotonic Saline;Drug: Indium-DTPA;Drug: Technetium Sulfur Colloid | Tim Corcoran | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 12 Years | N/A | All | 56 | Phase 1 | United States |
| 10 | EUCTR2015-004143-39-BE (EUCTR) | 30/11/2016 | 13/10/2016 | Saline hypertonic in preschoolers and lung structure as measured by computed tomography. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 19.0;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] | Product Name: Hypertonic saline INN or Proposed INN: SODIUM CHLORIDE 7% Other descriptive name: SODIUM CHLORIDE 7% Product Name: Isotonic saline INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Spain;Belgium;Denmark;Australia;Netherlands | ||
| 11 | NCT02657473 (ClinicalTrials.gov) | August 13, 2016 | 13/1/2016 | Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis | Long-term Inhaled Nebulized Tobramycin in Patients With Non-cystic Fibrosis Bronchiectasis. A Randomized Placebo Controlled Trial. The BATTLE Study Bronchiectasis And Tobramycin SoluTion InhaLation ThErapy. | Non-CF Bronchiectasis | Drug: tobramycin inhalation solution;Drug: Saline 0.9% inhalation solution | Medical Center Alkmaar | NULL | Completed | 18 Years | N/A | All | 58 | Phase 2/Phase 3 | Netherlands |
| 12 | EUCTR2015-004143-39-NL (EUCTR) | 09/08/2016 | 21/12/2015 | Saline hypertonic in preschoolers and lung structure as measured by computed tomography. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;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] | Product Name: Hypertonic saline INN or Proposed INN: SODIUM CHLORIDE 7% Other descriptive name: SODIUM CHLORIDE 7% Product Name: Isotonic saline INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% | Erasmus MC | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Spain;Belgium;Denmark;Australia;Netherlands;Italy | ||
| 13 | EUCTR2015-004841-13-IE (EUCTR) | 08/08/2016 | 07/06/2016 | A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi | 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] - Respiratory Tract Diseases [C08] | Product Code: VX-371 in hypertonic saline INN or Proposed INN: not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic Saline INN or Proposed INN: 4.2% NaCl/Inhalation solution | Vertex Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | France;United States;Czech Republic;Ireland;United Kingdom | ||
| 14 | EUCTR2015-004841-13-GB (EUCTR) | 20/07/2016 | 09/06/2016 | A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi | 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] - Respiratory Tract Diseases [C08] | Product Code: VX-371 in hypertonic saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic saline INN or Proposed INN: 4.2% NaCl/Inhalation solution | Vertex Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Czech Republic;Ireland;United Kingdom | ||
| 15 | NCT02354859 (ClinicalTrials.gov) | March 2016 | 30/7/2014 | A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study) | A Phase 2, Multi-Center, Randomized, Placebo-Controlled Study of IV Gallium Nitrate in Patients With Cystic Fibrosis (IGNITE Study) | Cystic Fibrosis | Drug: Gallium nitrate;Drug: Normal Saline | University of Washington | Cystic Fibrosis Foundation | Completed | 18 Years | N/A | All | 119 | Phase 2 | United States |
| 16 | NCT02709109 (ClinicalTrials.gov) | February 2016 | 29/2/2016 | A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi | Cystic Fibrosis | Drug: VX-371;Drug: Saline;Drug: Placebo;Drug: Orkambi | Parion Sciences | Vertex Pharmaceuticals Incorporated | Completed | 12 Years | N/A | All | 142 | Phase 2 | United States;France;Ireland;United Kingdom |
| 17 | NCT02343445 (ClinicalTrials.gov) | April 2015 | 13/1/2015 | Clearing Lungs With Epithelial Sodium Channel (ENaC) Inhibition in Cystic Fibrosis (CF) | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of P-1037 Solution for Inhalation in Patients With Cystic Fibrosis (CF) | Cystic Fibrosis | Drug: P-1037;Drug: Hypertonic Saline;Drug: Saline | Parion Sciences | Vertex Pharmaceuticals Incorporated | Completed | 12 Years | 80 Years | All | 142 | Phase 2 | United States |
| 18 | NCT02950883 (ClinicalTrials.gov) | March 24, 2015 | 27/10/2016 | Saline Hypertonic in Preschoolers + CT | Saline Hypertonic in Preschoolers With Cystic Fibrosis and Lung Structure as Measured by Computed Tomography (CT) | Cystic Fibrosis | Drug: Active Treatment Group 7% Hypertonic Saline;Drug: Control Group 0.9% Isotonic Saline | University of Washington, the Collaborative Health Studies Coordinating Center | Cystic Fibrosis Foundation | Completed | 3 Years | 5 Years | All | 116 | Phase 2/Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Italy;Netherlands;Spain |
| 19 | NCT02378467 (ClinicalTrials.gov) | March 1, 2015 | 27/2/2015 | Saline Hypertonic in Preschoolers | Saline Hypertonic in Preschoolers | Cystic Fibrosis | Drug: 7% Hypertonic Saline (HS);Drug: 0.9% Isotonic Saline (IS) | University of Washington, the Collaborative Health Studies Coordinating Center | Cystic Fibrosis Foundation | Completed | 3 Years | 5 Years | All | 150 | N/A | United States;Canada |
| 20 | NCT02141191 (ClinicalTrials.gov) | June 2014 | 12/5/2014 | A Study of Lung Clearance After Hypertonic Saline Delivery Using the tPAD Device | A Randomized Crossover Mucociliary Clearance Study of Aerosolized 7% NaCl Solution Administered Overnight by the tPAD Device to Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: inhaled hypertonic saline (7%) | University of Pittsburgh | Parion Sciences | Completed | 18 Years | N/A | All | 12 | Phase 1 | United States |
| 21 | NCT02081963 (ClinicalTrials.gov) | March 2014 | 6/3/2014 | Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis | A Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis | Non-Cystic Fibrosis Bronchiectasis | Drug: Amikacin;Drug: Normal saline | Qilu Hospital of Shandong University | NULL | Completed | 18 Years | 80 Years | All | 178 | Phase 4 | China |
| 22 | NCT01746784 (ClinicalTrials.gov) | February 2014 | 6/12/2012 | Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation | A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of N6022 to Evaluate Safety and Pharmacokinetics in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation (SNO1) | Cystic Fibrosis | Drug: N6022;Drug: Normal saline | Nivalis Therapeutics, Inc. | NULL | Completed | 18 Years | N/A | All | 66 | Phase 1 | United States |
| 23 | NCT01887197 (ClinicalTrials.gov) | June 2013 | 24/6/2013 | Repeatability and Response Study of Absorptive Clearance Scans | Repeatability and Response Study of Absorptive Clearance Scans | Cystic Fibrosis | Other: Absorptive clearance scan;Drug: inhaled hypertonic saline (7%);Drug: mannitol inhalation powder | Tim Corcoran | NULL | Completed | 18 Years | N/A | All | 24 | Phase 1 | United States |
| 24 | NCT00928135 (ClinicalTrials.gov) | January 22, 2013 | 18/6/2009 | Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Cystic Fibrosis (CF) Subjects | Randomized Controlled Study of Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Hospitalized Patients With Exacerbation of Cystic Fibrosis | Cystic Fibrosis | Drug: Xylitol;Drug: Saline | Joseph Zabner | NULL | Completed | 12 Years | N/A | All | 63 | Phase 1/Phase 2 | United States |
| 25 | NCT01619657 (ClinicalTrials.gov) | June 2012 | 12/6/2012 | Preventive Inhalation of Hypertonic Saline in Infants With Cystic Fibrosis | Randomized, Double-blind, Controlled Pilot Study on Safety of Hypertonic Saline as Preventive Inhalation Therapy in Newborns and Infants With Cystic Fibrosis | Cystic Fibrosis Lung Disease | Drug: 6% Hypertonic Saline (HS), 4mL;Drug: 0.9% Isotonic Saline (IS), 4mL | Heidelberg University | German Center for Lung Research | Completed | N/A | 4 Months | All | 42 | Phase 2 | Germany |
| 26 | NCT02276898 (ClinicalTrials.gov) | November 2011 | 22/10/2014 | A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index | A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index as a Short-term Pharmacodynamic Biomarker in Patients With Cystic Fibrosis. | Cystic Fibrosis | Drug: Hypertonic Saline 7%;Drug: Isotonic Saline 0.9% (Placebo) | The Hospital for Sick Children | NULL | Completed | 6 Years | 18 Years | Both | 24 | Phase 2 | Canada |
| 27 | NCT01355796 (ClinicalTrials.gov) | May 2011 | 16/5/2011 | Inhaled Xylitol Versus Saline in Stable Subjects With Cystic Fibrosis | Randomized Cross Over Study of Inhaled Hypertonic Xylitol Versus Hypertonic Saline in Stable Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: Xylitol;Drug: Hypertonic saline | Joseph Zabner | Ann & Robert H Lurie Children's Hospital of Chicago;Northwestern University | Completed | 16 Years | N/A | All | 30 | Phase 1/Phase 2 | United States |
| 28 | NCT01465529 (ClinicalTrials.gov) | May 2011 | 31/10/2011 | A Cross-over Study of OligoG in Subjects With Cystic Fibrosis. Fibrosis | A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: OligoG CF-5/20;Drug: Saline | AlgiPharma AS | NULL | Completed | 18 Years | N/A | Both | 26 | Phase 1/Phase 2 | Ireland;United Kingdom |
| 29 | NCT01223183 (ClinicalTrials.gov) | September 2010 | 14/10/2010 | Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis | Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis | Cystic Fibrosis | Drug: hypertonic saline (7%);Drug: isotonic saline | University of Pittsburgh | NULL | Completed | 18 Years | N/A | All | 20 | Phase 1 | United States |
| 30 | NCT00996424 (ClinicalTrials.gov) | January 2010 | 15/10/2009 | The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function | The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function. | Cystic Fibrosis | Drug: Acetylcysteine;Drug: normal saline | University Hospital, Ghent | BVSM | Terminated | 6 Years | 64 Years | Both | 19 | Phase 4 | Belgium |
| 31 | EUCTR2008-008317-20-BE (EUCTR) | 13/11/2009 | 21/09/2009 | The effect of inhaled N-Acetylcysteine compared to normal saline on sputum rheology and lung function | The effect of inhaled N-Acetylcysteine compared to normal saline on sputum rheology and lung function | Cystic Fibrosis MedDRA version: 12.0;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Lysomucil 10 % Product Name: N-acetylcysteine INN or Proposed INN: Acetylcysteine | University Hospital Ghent | NULL | Not Recruiting | Female: yes Male: yes | Belgium | ||||
| 32 | NCT01094704 (ClinicalTrials.gov) | November 2009 | 19/3/2010 | Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic Fibrosis | Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic Fibrosis | Cystic Fibrosis | Drug: sodium chloride (7%) | University of North Carolina, Chapel Hill | Johns Hopkins University;Novartis Pharmaceuticals | Completed | 18 Years | N/A | All | 16 | Phase 1 | United States |
| 33 | NCT01031706 (ClinicalTrials.gov) | September 2009 | 11/12/2009 | Effect of Hypertonic Saline on Mucus Clearance in Children Ages 5-12 With Cystic Fibrosis | Sustained Impact of Hypertonic Saline on Mucociliary Clearance in Young Children With Cystic Fibrosis | Cystic Fibrosis | Drug: Hypertonic Saline;Drug: Placebo | University of North Carolina, Chapel Hill | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 5 Years | 12 Years | All | 23 | N/A | United States |
| 34 | NCT01880723 (ClinicalTrials.gov) | May 2009 | 15/6/2013 | Utilizing Exhaled Breathe Condensate Collection to Study Ion Regulation in Cystic Fibrosis | Modifying Genes in Cystic Fibrosis: The Beta-2 Adrenergic Receptors and Epithelial Na+ Channels | Cystic Fibrosis;Healthy | Drug: Albuterol;Drug: Placebo saline | University of Arizona | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 15 Years | 55 Years | All | 32 | N/A | United States |
| 35 | NCT00709280 (ClinicalTrials.gov) | April 2009 | 1/7/2008 | Infant Study of Inhaled Saline in Cystic Fibrosis | Infant Study of Inhaled Saline in Cystic Fibrosis | Cystic Fibrosis | Drug: 7% Hypertonic Saline (HS);Drug: 0.9% Isotonic Saline (IS) | CF Therapeutics Development Network Coordinating Center | Cystic Fibrosis Foundation Therapeutics;National Heart, Lung, and Blood Institute (NHLBI) | Completed | 4 Months | 59 Months | Both | 321 | N/A | United States;Canada |
| 36 | NCT01377792 (ClinicalTrials.gov) | March 2009 | 9/5/2011 | Study of Long-term Treatment With Hypertonic Saline in Patients With Cystic Fibrosis | Phase 4 Study of the Efficacy of Long-term Treatment With Hypertonic Saline on Pulmonary Exacerbations in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Hypertonic saline | Adelaida Lamas Ferreiro | NULL | Completed | 6 Years | N/A | Both | 71 | Phase 4 | Spain |
| 37 | NCT00700050 (ClinicalTrials.gov) | April 2008 | 16/6/2008 | Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways | Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways - A Pilot Study | Cystic Fibrosis | Drug: Hypertonic saline | The Hospital for Sick Children | Unity Health Toronto | Active, not recruiting | 14 Years | 28 Years | All | 80 | Canada | |
| 38 | NCT00628134 (ClinicalTrials.gov) | March 2008 | 22/2/2008 | Self-dispersing Liquids as Aerosol Drug Carriers | Self-dispersing Liquids as Aerosol Drug Carriers | Cystic Fibrosis | Drug: calfactant;Drug: isotonic saline | University of Pittsburgh | Cystic Fibrosis Foundation Therapeutics | Completed | 18 Years | N/A | All | 8 | N/A | United States |
| 39 | NCT00635141 (ClinicalTrials.gov) | March 2008 | 4/3/2008 | The Effect of Hypertonic Saline on the Lung Clearance Index in Patients With Cystic Fibrosis | The Effect of Inhaled Hypertonic Saline (7%) Versus Normal Saline (0.9%) on the Lung Clearance Index in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: hypertonic saline (7 %) and isotonic saline (0.9%) | The Hospital for Sick Children | Canadian Cystic Fibrosis Foundation | Completed | 6 Years | 18 Years | Both | 20 | Phase 3 | Canada |
| 40 | NCT00484263 (ClinicalTrials.gov) | December 2007 | 7/6/2007 | The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non Cystic Fibrosis Bronchiectasis | The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non-cystic Fibrosis Bronchiectasis. | Bronchiectasis | Drug: Hypertonic saline 6% - | The Alfred | NULL | Completed | 18 Years | N/A | Both | 40 | Phase 3 | Australia |
| 41 | NCT00546663 (ClinicalTrials.gov) | September 2007 | 17/10/2007 | Tolerability of Inhaled Hypertonic Saline in Infants With Cystic Fibrosis | A Pilot Study to Evaluate the Tolerability of Inhaled 7% Hypertonic Saline in Infants With Cystic Fibrosis | Cystic Fibrosis | Drug: inhaled 7% hypertonic saline (HS) | CF Therapeutics Development Network Coordinating Center | Cystic Fibrosis Foundation Therapeutics | Completed | 12 Months | 30 Months | Both | 19 | N/A | United States;Canada |
| 42 | NCT00534079 (ClinicalTrials.gov) | September 2007 | 21/9/2007 | Nasal Inhalation of Pulmozyme in Patients With Cystic Fibrosis and Chronic Rhinosinusitis | Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis - a Double Blind Placebo-controlled Cross-over, Bicenter, Prospective Clinical Study | Cystic Fibrosis;Rhinosinusitis | Drug: Dornase alfa (Pulmozyme);Drug: isotonic saline | University of Jena | NULL | Completed | 5 Years | N/A | Both | 23 | Phase 3 | Germany |
| 43 | NCT00506688 (ClinicalTrials.gov) | July 2007 | 24/7/2007 | Efficacy and Safety Study of Inhaled Glutathione in Cystic Fibrosis Patients | Randomized, Placebo-controlled, Double-blinded Study to Investigate the Efficacy and Safety of a 24-week Inhalation Treatment With Glutathione in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: reduced glutathione sodium salt;Drug: 0.9% normal saline (control) | Mukoviszidose Institut gGmbH | Cystic Fibrosis Foundation Therapeutics | Completed | 8 Years | N/A | Both | 153 | Phase 2 | Germany |
| 44 | NCT01293084 (ClinicalTrials.gov) | July 2007 | 9/2/2011 | Hypertonic Saline and Mucociliary Clearance in Children | Acute Inhalation of Hypertonic Saline Does Not Improve Mucociliary Clearance in All Children With Cystic Fibrosis | Cystic Fibrosis | Drug: 0.12% saline;Drug: 7% saline | Johns Hopkins University | Cystic Fibrosis Foundation Therapeutics | Completed | 7 Years | 12 Years | All | 17 | Phase 2 | NULL |
| 45 | EUCTR2007-002707-40-BE (EUCTR) | 28/06/2007 | 04/06/2007 | The effect of inhalation with hypertonic saline (7%) on lung function and sputum rheology in Cystic Fibrosis patients | The effect of inhalation with hypertonic saline (7%) on lung function and sputum rheology in Cystic Fibrosis patients | Mucoviscidose MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Hypertonic saline solution INN or Proposed INN: Sodium Chloride Product Name: Normal saline solution INN or Proposed INN: Sodium Chloride | University Hospital Ghent | NULL | Not Recruiting | Female: yes Male: yes | 60 | Belgium | |||
| 46 | NCT00721071 (ClinicalTrials.gov) | December 2006 | 21/7/2008 | Utility of Induced Sputum Using Hypertonic Saline to Evaluate Infection and Inflammation in Cystic Fibrosis | Diagnostic Utility of Induced Sputum Using Hypertonic Saline to Evaluate Airway Infection and Inflammation in Cystic Fibrosis | Cystic Fibrosis | Drug: Hypertonic Saline | The Hospital for Sick Children | NULL | Completed | 6 Years | 18 Years | Both | 95 | Phase 2 | Canada |
| 47 | NCT00671723 (ClinicalTrials.gov) | October 2006 | 30/4/2008 | Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis in Non-Cystic Fibrosis Patients | Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis | Atelectasis | Drug: Normal saline:;Drug: Hypertonic Saline;Drug: Dornase alpha | University of Oklahoma | NULL | Completed | 18 Years | 90 Years | All | 33 | N/A | United States |
| 48 | NCT00753987 (ClinicalTrials.gov) | March 2006 | 15/9/2008 | Tolerability of Hypertonic Saline in Infants With Cystic Fibrosis | Tolerability of Hypertonic Saline in Infants With Cystic Fibrosis | Cystic Fibrosis | Drug: Hypertonic Saline | The Hospital for Sick Children | NULL | Completed | 2 Months | 2 Years | Both | 13 | Phase 1 | Canada |
| 49 | NCT00163852 (ClinicalTrials.gov) | February 2004 | 12/9/2005 | Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis | Salt Replacement for Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis | Cystic Fibrosis | Drug: Normal saline IV, salt tablets | Bayside Health | National Health and Medical Research Council, Australia;Monash University;Cystic Fibrosis Australia | Recruiting | 18 Years | 75 Years | Both | 40 | Phase 2/Phase 3 | Australia |
| 50 | NCT00274391 (ClinicalTrials.gov) | July 2001 | 9/1/2006 | Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis | Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis | Cystic Fibrosis | Drug: 7% NaCl;Drug: Amiloride HCl | University of North Carolina | Cystic Fibrosis Foundation Therapeutics | Completed | 14 Years | N/A | Both | 24 | Phase 2 | United States |
| 51 | NCT00271310 (ClinicalTrials.gov) | September 2000 | 29/12/2005 | The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis | The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: hypertonic saline | Royal Prince Alfred Hospital, Sydney, Australia | Cystic Fibrosis Foundation Therapeutics;National Health and Medical Research Council, Australia;Cystic Fibrosis Trust | Completed | 6 Years | N/A | Both | 164 | Phase 3 | NULL |
| 52 | EUCTR2015-004841-13-FR (EUCTR) | 23/06/2016 | A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi | 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] | Product Code: VX-371 in hypertonic saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Ivacaftor INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic saline INN or Proposed INN: 4.2% NaCl/inhalation solution | Vertex Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Czech Republic;Ireland;United Kingdom | |||
| 53 | EUCTR2015-004143-39-FR (EUCTR) | 30/03/2017 | Saline hypertonic in preschoolers and lung structure as measured by computed tomography. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;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] | Product Name: Hypertonic saline 7% INN or Proposed INN: SODIUM CHLORIDE Other descriptive name: SODIUM CHLORIDE PH. EUR. Product Name: Isotonic saline 0.9% INN or Proposed INN: SODIUM CHLORIDE Other descriptive name: SODIUM CHLORIDE PH. EUR. | Erasmus MC | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | United States;France;Spain;Belgium;Denmark;Australia;Netherlands;Italy |