299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
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 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 |
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 |
| 11 | 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 |
| 12 | 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 |
| 13 | 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 |
| 14 | 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 |
| 15 | 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 |
| 16 | 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 |
| 17 | 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 |
| 18 | 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 |
| 19 | 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 |
| 20 | 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 |
| 21 | 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 |
| 22 | 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 |
| 23 | 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 |
| 24 | 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 | |
| 25 | 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 |
| 26 | 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 |
| 27 | 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 |
| 28 | 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 |
| 29 | 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 | |||
| 30 | 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 |
| 31 | 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 |
| 32 | 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 |
| 33 | 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 |
| 34 | 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 |
| 35 | 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 | |||
| 36 | 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 |