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

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

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
25 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-002579-16-SE26/08/201816/07/2018Measurement of the posaconazole concentration in exhaled breath in CF patients after a single dose posaconazole to correlate to the concentration in blood and saliva.Evaluation of the possible use of analysis of posaconazole in exhaled breath as a surrogate marker for the lung to monitor adequate dosages of posaconazole in CF patients treated for Aspergillus spp. related lung-disease. Part 1. Pharmacokinetic single center study. Cystic Fibrosis (CF) is the most common life–limiting autosomal recessive disease among people of European heritage. The condition is a result of a mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene on chromosome seven, which encodes a chloride channel. In the lung defective channel activity leads to thick, viscous secretion and impaired mucociliary clearance. This causes trapping of mucus, colonization with bacteria and fungi, and a persistent inflammatory response.
MedDRA version: 20.0Level: PTClassification code 10074549Term: Cystic fibrosis respiratory infection suppressionSystem Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Noxafil® Karolinska University Hospital, Stockholm CF centerNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2Sweden
2NCT03367494March 1, 201822/11/2017A New Optical Sweat Test Method Based on a Citric Acid-derived Multi-halide SensorA New Optical Sweat Test Method Based on a Citric Acid-derived Multi-halide SensorCystic FibrosisDiagnostic Test: Measurement of Sweat Chloride and Sweat BromideMilton S. Hershey Medical CenterNULLActive, not recruiting18 YearsN/AAll50N/AUnited States
3EUCTR2016-004033-25-ES19/06/201731/03/2017Randomized clinical trial to assess the effect of nebulizad bicarbonate on bacterial infections in patients with cystic fibrosisEfect of nebulized bicarbonate on bacterial infections in patients with cystic fibrosis. Randomized clinical trial Cystic Fibrosis
MedDRA version: 20.0Level: LLTClassification code 10074550Term: Preventive antimicrobial therapy in cystic fibrosisSystem Organ Class: 100000004865
MedDRA version: 20.0Level: LLTClassification code 10011764Term: Cystic fibrosis NOSSystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Sodium bicarbonate
INN or Proposed INN: Sodium Bicarbonate
Other descriptive name: SODIUM BICARBONATE BP
Product Name: sodium chloride
INN or Proposed INN: Sodium chloride
Other descriptive name: SODIUM CHLORIDE
Product Name: sodium chloride
INN or Proposed INN: Sodium chloride
Other descriptive name: SODIUM CHLORIDE
Product Name: Water for injections
INN or Proposed INN: water for injections
Other descriptive name: WATER FOR INJECTIONS, EP
Fundació Parc TaulíNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Spain
4EUCTR2015-004143-39-DK14/02/201725/10/2016Saline 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: 19.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem 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 MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Australia;Denmark;Netherlands
5EUCTR2015-004143-39-BE30/11/201613/10/2016Saline 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: 19.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 19.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2015-004143-39-NL09/08/201621/12/2015Saline 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: 20.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem 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
7NCT03312140November 6, 20144/10/2017Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic FibrosisExamination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic FibrosisCystic Fibrosis Liver DiseaseDrug: Choline ChlorideUniversity Hospital TuebingenNULLCompleted18 YearsN/AMale10N/ANULL
8NCT03391414August 201420/6/2012Effects of Inhaled Bicarbonate on Airway pH in Cystic FibrosisEffects of Inhaled Bicarbonate on Airway pH in Cystic FibrosisCystic FibrosisDrug: hypertonic bicarbonate;Drug: sodium chlorideJoseph PilewskiCystic Fibrosis Foundation TherapeuticsCompleted12 YearsN/AAll12Phase 1United States
9EUCTR2013-003774-27-GB20/01/201427/11/2013A study to investigate lung deposition of radiolabelled OligoG(v1.0)An open label, randomised, two-way crossover scintigraphic study to investigate lung deposition of radiolabelled OligoG delivered as a dry powder and as a nebulised solution in cystic fibrosis patients - A study to investigate lung deposition of radiolabelled OligoG (v1.0) Cystic fibrosis (CF) is an autosomal, recessive inheritable disease caused by a homozygote defect at the long arm of Chromosome 7. This mutation causes absence or defect of the cystic fibrosis transmembrane conductance regulator, an ion channel transporting chloride and bicarbonate ions across the cell membrane in exocrine glands. Decreased chloride transport leads to dehydration of the mucus layer, and decreased bicarbonate to increased mucus adhesion. Mucus stagnation results.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Radiolabelled OligoG CF-5/20 Dry Powder for Inhalation (DPI)
INN or Proposed INN: OligoG
Product Name: Radiolabelled OligoG CF-5/20 6% Solution for Nebulisation
INN or Proposed INN: OligoG
AlgiPharma ASNULLNot RecruitingFemale: yes
Male: yes
12Phase 2United Kingdom
10NCT01181622August 201012/8/2010A Safety and Tolerability Study of Denufosol in 2-4 Year OldsA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 7-Day Safety and Tolerability Study of Denufosol Tetrasodium Inhalation Solution Administered Via PARI LC® Star in Patients 2 to 4 Years of Age With Cystic FibrosisCystic FibrosisDrug: denufosol tetrasodium Inhalation Solution;Drug: 0.9% w/v sodium chloride solutionMerck Sharp & Dohme Corp.NULLCompleted2 Years4 YearsBoth25Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT01086839March 201012/3/2010Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic RhinosinusitisSino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis. A Multicenter, Randomized, Double-blind, Placebo-controlled, Prospective Clinical TrialCystic Fibrosis;RhinosinusitisDrug: sodium chloride 6%;Drug: sodium chloride 0,9%University of JenaNULLCompleted8 YearsN/ABoth69N/AGermany
12NCT01094704November 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
13EUCTR2006-006693-24-CZ16/07/200809/05/2007A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1Level: PTClassification code 10011763Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
INN or Proposed INN: Not available
Other descriptive name: 2622U90 Duramycin
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
14EUCTR2006-006693-24-DE29/08/200729/05/2007A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1Level: PTClassification code 10011763Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
INN or Proposed INN: Not available
Other descriptive name: 2622U90 Duramycin
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Phase 2;Phase 3France;Hungary;Czech Republic;Poland;Spain;Austria;Germany;Italy;Sweden
15EUCTR2006-006693-24-FR23/08/200716/05/2007A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In Cystic Fibrosis chloride transport accross the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli 1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.Product Name: Moli 1901 (2622U90, duramycin)
Product Code: Moli 1901
AOP Orphan Pharmaceuticals AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2006-006693-24-SE16/08/200702/07/2007A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1Level: PTClassification code 10011763Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
17EUCTR2006-006693-24-HU27/07/200718/06/2007A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1Level: PTClassification code 10011763Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
18NCT00425165July 200719/1/2007Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung DiseaseA Randomized, Double-Blind, Two Way Crossover Evaluation of the Effects of a Single Dose of Denufosol Tetrasodium (INS37217) Inhalation Solution Versus Placebo (0.9% Sodium Chloride Solution) on Mucociliary Clearance in Patients With Mild to Moderate Cystic Fibrosis Lung DiseaseCystic FibrosisDrug: denufosol tetrasodium (INS37217) Inhalation SolutionMerck Sharp & Dohme Corp.NULLTerminated10 YearsN/ABoth6Phase 2United States
19EUCTR2007-002707-40-BE28/06/200704/06/2007The 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: 9.1Level: LLTClassification code 10011763Term: 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
20EUCTR2006-006693-24-AT09/05/200711/01/2007A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1Level: PTClassification code 10011763Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT00357279July 200625/7/2006Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung DiseaseA Multi-Center, Double-Blind, Placebo-Controlled Randomized, Efficacy and Safety Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Mild Cystic Fibrosis Lung DiseaseCystic FibrosisDrug: denufosol tetrasodium (INS37217) Inhalation Solution;Drug: Placebo - 0.9% w/v sodium chloride solutionMerck Sharp & Dohme Corp.NULLCompleted5 YearsN/ABoth352Phase 3United States;Canada
22EUCTR2005-004344-30-HU10/05/200623/12/2005An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung DiseaseAn Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10,000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride ans water in the lungs thereby reducing the formation of mucus plugs and improving clearance.Product Name: Moli1901 (2622U90, duramycin)
Product Code: EU Orphan Designation Number EU/3/02/120
Other descriptive name: Duramycin, 2622U90
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
18Hungary
23NCT00308243March 200627/3/2006Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. A Phase I, Double Blind, Placebo Controlled, Safety Study. Stage 1)Cystic FibrosisDrug: Sodium Pyruvate in 0.9% Sodium Chloride SolutionEmphycorpCellular SciencesCompleted18 YearsN/ABoth15Phase 1United States
24EUCTR2005-004344-30-AT31/10/200526/09/2005An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung DiseaseAn Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10,000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride ans water in the lungs thereby reducing the formation of mucus plugs and improving clearance.Product Name: Moli1901 (2622U90, duramycin)
Product Code: EU Orphan Designation Number EU/3/02/120
Other descriptive name: Duramycin, 2622U90
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
18Hungary;Austria
25EUCTR2006-006693-24-PL11/10/2007A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1Level: PTClassification code 10011763Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
INN or Proposed INN: Not available
Other descriptive name: 2622U90 Duramycin
AOP Orphan Pharmaceuticals AGNULLNAFemale: yes
Male: yes
160Phase 2France;Hungary;Czech Republic;Spain;Poland;Austria;Germany;Italy;Sweden