299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details


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36 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2015-004143-39-IT
(EUCTR)
19/12/201820/09/2018Saline 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 MCNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Spain;Belgium;Denmark;Australia;Netherlands;Italy
2EUCTR2015-004143-39-ES
(EUCTR)
19/04/201731/03/2017Saline 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 MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Spain;Denmark;Australia;Netherlands
3EUCTR2015-004143-39-DK
(EUCTR)
14/02/201725/10/2016Saline 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 MCNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Spain;Belgium;Australia;Denmark;Netherlands;Italy
4EUCTR2015-004841-13-CZ
(EUCTR)
04/01/201710/08/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA 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 IncorporatedNULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Czech Republic;Ireland;United Kingdom
5NCT02947126
(ClinicalTrials.gov)
January 201725/10/2016Multilevel Models of Therapeutic Response in the LungsMultilevel Models of Therapeutic Response in the LungsCystic FibrosisDrug: Hypertonic Saline;Drug: Isotonic Saline;Drug: Indium-DTPA;Drug: Technetium Sulfur ColloidTim CorcoranNational Heart, Lung, and Blood Institute (NHLBI)Completed12 YearsN/AAll56Phase 1United States
6EUCTR2015-004143-39-BE
(EUCTR)
30/11/201613/10/2016Saline 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 MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Spain;Belgium;Denmark;Australia;Netherlands
7EUCTR2015-004143-39-NL
(EUCTR)
09/08/201621/12/2015Saline 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 MCNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Spain;Belgium;Denmark;Australia;Netherlands;Italy
8EUCTR2015-004841-13-IE
(EUCTR)
08/08/201607/06/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA 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.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Czech Republic;Ireland;United Kingdom
9EUCTR2015-004841-13-GB
(EUCTR)
20/07/201609/06/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA 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.NULLNot 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): noFrance;United States;Czech Republic;Ireland;United Kingdom
10NCT02343445
(ClinicalTrials.gov)
April 201513/1/2015Clearing 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 FibrosisDrug: P-1037;Drug: Hypertonic Saline;Drug: SalineParion SciencesVertex Pharmaceuticals IncorporatedCompleted12 Years80 YearsAll142Phase 2United States
11NCT02950883
(ClinicalTrials.gov)
March 24, 201527/10/2016Saline Hypertonic in Preschoolers + CTSaline Hypertonic in Preschoolers With Cystic Fibrosis and Lung Structure as Measured by Computed Tomography (CT)Cystic FibrosisDrug: Active Treatment Group 7% Hypertonic Saline;Drug: Control Group 0.9% Isotonic SalineUniversity of Washington, the Collaborative Health Studies Coordinating CenterCystic Fibrosis FoundationCompleted3 Years5 YearsAll116Phase 2/Phase 3United States;Australia;Belgium;Canada;Denmark;France;Italy;Netherlands;Spain
12NCT02378467
(ClinicalTrials.gov)
March 1, 201527/2/2015Saline Hypertonic in PreschoolersSaline Hypertonic in PreschoolersCystic FibrosisDrug: 7% Hypertonic Saline (HS);Drug: 0.9% Isotonic Saline (IS)University of Washington, the Collaborative Health Studies Coordinating CenterCystic Fibrosis FoundationCompleted3 Years5 YearsAll150N/AUnited States;Canada
13NCT02141191
(ClinicalTrials.gov)
June 201412/5/2014A Study of Lung Clearance After Hypertonic Saline Delivery Using the tPAD DeviceA Randomized Crossover Mucociliary Clearance Study of Aerosolized 7% NaCl Solution Administered Overnight by the tPAD Device to Subjects With Cystic FibrosisCystic FibrosisDrug: inhaled hypertonic saline (7%)University of PittsburghParion SciencesCompleted18 YearsN/AAll12Phase 1United States
14NCT01887197
(ClinicalTrials.gov)
June 201324/6/2013Repeatability and Response Study of Absorptive Clearance ScansRepeatability and Response Study of Absorptive Clearance ScansCystic FibrosisOther: Absorptive clearance scan;Drug: inhaled hypertonic saline (7%);Drug: mannitol inhalation powderTim CorcoranNULLCompleted18 YearsN/AAll24Phase 1United States
15NCT00928135
(ClinicalTrials.gov)
January 22, 201318/6/2009Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Cystic Fibrosis (CF) SubjectsRandomized Controlled Study of Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Hospitalized Patients With Exacerbation of Cystic FibrosisCystic FibrosisDrug: Xylitol;Drug: SalineJoseph ZabnerNULLCompleted12 YearsN/AAll63Phase 1/Phase 2United States
16NCT01619657
(ClinicalTrials.gov)
June 201212/6/2012Preventive Inhalation of Hypertonic Saline in Infants With Cystic FibrosisRandomized, Double-blind, Controlled Pilot Study on Safety of Hypertonic Saline as Preventive Inhalation Therapy in Newborns and Infants With Cystic FibrosisCystic Fibrosis Lung DiseaseDrug: 6% Hypertonic Saline (HS), 4mL;Drug: 0.9% Isotonic Saline (IS), 4mLHeidelberg UniversityGerman Center for Lung ResearchCompletedN/A4 MonthsAll42Phase 2Germany
17NCT02276898
(ClinicalTrials.gov)
November 201122/10/2014A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance IndexA 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 FibrosisDrug: Hypertonic Saline 7%;Drug: Isotonic Saline 0.9% (Placebo)The Hospital for Sick ChildrenNULLCompleted6 Years18 YearsBoth24Phase 2Canada
18NCT01355796
(ClinicalTrials.gov)
May 201116/5/2011Inhaled Xylitol Versus Saline in Stable Subjects With Cystic FibrosisRandomized Cross Over Study of Inhaled Hypertonic Xylitol Versus Hypertonic Saline in Stable Subjects With Cystic FibrosisCystic FibrosisDrug: Xylitol;Drug: Hypertonic salineJoseph ZabnerAnn & Robert H Lurie Children's Hospital of Chicago;Northwestern UniversityCompleted16 YearsN/AAll30Phase 1/Phase 2United States
19NCT01223183
(ClinicalTrials.gov)
September 201014/10/2010Absorptive Clearance After Inhaled Osmotics in Cystic FibrosisAbsorptive Clearance After Inhaled Osmotics in Cystic FibrosisCystic FibrosisDrug: hypertonic saline (7%);Drug: isotonic salineUniversity of PittsburghNULLCompleted18 YearsN/AAll20Phase 1United States
20NCT01094704
(ClinicalTrials.gov)
November 200919/3/2010Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic FibrosisDurability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic FibrosisCystic FibrosisDrug: sodium chloride (7%)University of North Carolina, Chapel HillJohns Hopkins University;Novartis PharmaceuticalsCompleted18 YearsN/AAll16Phase 1United States
21NCT01031706
(ClinicalTrials.gov)
September 200911/12/2009Effect of Hypertonic Saline on Mucus Clearance in Children Ages 5-12 With Cystic FibrosisSustained Impact of Hypertonic Saline on Mucociliary Clearance in Young Children With Cystic FibrosisCystic FibrosisDrug: Hypertonic Saline;Drug: PlaceboUniversity of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)Completed5 Years12 YearsAll23N/AUnited States
22NCT00709280
(ClinicalTrials.gov)
April 20091/7/2008Infant Study of Inhaled Saline in Cystic FibrosisInfant Study of Inhaled Saline in Cystic FibrosisCystic FibrosisDrug: 7% Hypertonic Saline (HS);Drug: 0.9% Isotonic Saline (IS)CF Therapeutics Development Network Coordinating CenterCystic Fibrosis Foundation Therapeutics;National Heart, Lung, and Blood Institute (NHLBI)Completed4 Months59 MonthsBoth321N/AUnited States;Canada
23NCT01377792
(ClinicalTrials.gov)
March 20099/5/2011Study of Long-term Treatment With Hypertonic Saline in Patients With Cystic FibrosisPhase 4 Study of the Efficacy of Long-term Treatment With Hypertonic Saline on Pulmonary Exacerbations in Patients With Cystic FibrosisCystic FibrosisDrug: Hypertonic salineAdelaida Lamas FerreiroNULLCompleted6 YearsN/ABoth71Phase 4Spain
24NCT00700050
(ClinicalTrials.gov)
April 200816/6/2008Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis AirwaysModulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways - A Pilot StudyCystic FibrosisDrug: Hypertonic salineThe Hospital for Sick ChildrenUnity Health TorontoActive, not recruiting14 Years28 YearsAll80Canada
25NCT00635141
(ClinicalTrials.gov)
March 20084/3/2008The Effect of Hypertonic Saline on the Lung Clearance Index in Patients With Cystic FibrosisThe Effect of Inhaled Hypertonic Saline (7%) Versus Normal Saline (0.9%) on the Lung Clearance Index in Patients With Cystic FibrosisCystic FibrosisDrug: hypertonic saline (7 %) and isotonic saline (0.9%)The Hospital for Sick ChildrenCanadian Cystic Fibrosis FoundationCompleted6 Years18 YearsBoth20Phase 3Canada
26NCT00484263
(ClinicalTrials.gov)
December 20077/6/2007The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non Cystic Fibrosis BronchiectasisThe Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non-cystic Fibrosis Bronchiectasis.BronchiectasisDrug: Hypertonic saline 6% -The AlfredNULLCompleted18 YearsN/ABoth40Phase 3Australia
27NCT00546663
(ClinicalTrials.gov)
September 200717/10/2007Tolerability of Inhaled Hypertonic Saline in Infants With Cystic FibrosisA Pilot Study to Evaluate the Tolerability of Inhaled 7% Hypertonic Saline in Infants With Cystic FibrosisCystic FibrosisDrug: inhaled 7% hypertonic saline (HS)CF Therapeutics Development Network Coordinating CenterCystic Fibrosis Foundation TherapeuticsCompleted12 Months30 MonthsBoth19N/AUnited States;Canada
28NCT01293084
(ClinicalTrials.gov)
July 20079/2/2011Hypertonic Saline and Mucociliary Clearance in ChildrenAcute Inhalation of Hypertonic Saline Does Not Improve Mucociliary Clearance in All Children With Cystic FibrosisCystic FibrosisDrug: 0.12% saline;Drug: 7% salineJohns Hopkins UniversityCystic Fibrosis Foundation TherapeuticsCompleted7 Years12 YearsAll17Phase 2NULL
29EUCTR2007-002707-40-BE
(EUCTR)
28/06/200704/06/2007The 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 GhentNULLNot RecruitingFemale: yes
Male: yes
60Belgium
30NCT00721071
(ClinicalTrials.gov)
December 200621/7/2008Utility of Induced Sputum Using Hypertonic Saline to Evaluate Infection and Inflammation in Cystic FibrosisDiagnostic Utility of Induced Sputum Using Hypertonic Saline to Evaluate Airway Infection and Inflammation in Cystic FibrosisCystic FibrosisDrug: Hypertonic SalineThe Hospital for Sick ChildrenNULLCompleted6 Years18 YearsBoth95Phase 2Canada
31NCT00671723
(ClinicalTrials.gov)
October 200630/4/2008Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis in Non-Cystic Fibrosis PatientsDornase Alpha Versus Hypertonic Saline for Lung AtelectasisAtelectasisDrug: Normal saline:;Drug: Hypertonic Saline;Drug: Dornase alphaUniversity of OklahomaNULLCompleted18 Years90 YearsAll33N/AUnited States
32NCT00753987
(ClinicalTrials.gov)
March 200615/9/2008Tolerability of Hypertonic Saline in Infants With Cystic FibrosisTolerability of Hypertonic Saline in Infants With Cystic FibrosisCystic FibrosisDrug: Hypertonic SalineThe Hospital for Sick ChildrenNULLCompleted2 Months2 YearsBoth13Phase 1Canada
33NCT00274391
(ClinicalTrials.gov)
July 20019/1/2006Efficacy of Amiloride and Hypertonic Saline in Cystic FibrosisEfficacy of Amiloride and Hypertonic Saline in Cystic FibrosisCystic FibrosisDrug: 7% NaCl;Drug: Amiloride HClUniversity of North CarolinaCystic Fibrosis Foundation TherapeuticsCompleted14 YearsN/ABoth24Phase 2United States
34NCT00271310
(ClinicalTrials.gov)
September 200029/12/2005The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic FibrosisThe Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic FibrosisCystic FibrosisDrug: hypertonic salineRoyal Prince Alfred Hospital, Sydney, AustraliaCystic Fibrosis Foundation Therapeutics;National Health and Medical Research Council, Australia;Cystic Fibrosis TrustCompleted6 YearsN/ABoth164Phase 3NULL
35EUCTR2015-004841-13-FR
(EUCTR)
23/06/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA 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.NULLNot 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): noUnited States;France;Czech Republic;Ireland;United Kingdom
36EUCTR2015-004143-39-FR
(EUCTR)
30/03/2017Saline 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 MCNULLNot RecruitingFemale: yes
Male: yes
120Phase 3United States;France;Spain;Belgium;Denmark;Australia;Netherlands;Italy