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


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170

  
7 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2019-000261-21-GB
(EUCTR)
05/11/201905/06/2019A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler - BALANCE - CF(TM) 1A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis - BALANCE - CF(TM) 1 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 Name: BI 1265162 10 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 25 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 50 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 100 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
98Phase 2Sweden;United Kingdom;Germany;Ireland;Belgium;Spain;Canada;France;United States
2EUCTR2019-000261-21-BE
(EUCTR)
07/10/201929/05/2019A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler – BALANCE – CF(TM)1A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis – BALANCE – CF(TM)1 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 Name: BI 1265162 10 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 25 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 50 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 100 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
98Phase 2United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden
3NCT04059094
(ClinicalTrials.gov)
September 16, 201915/8/2019A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat® Inhaler - BALANCE - CF™1A Randomised, Double-blind, Placebo-controlled and Parallel Group Trial to Evaluate Efficacy and Safety of Twice Daily Inhaled Doses of BI 1265162 Delivered by Respimat® Inhaler as add-on Therapy to Standard of Care Over 4 Weeks in Patients With Cystic Fibrosis - BALANCE - CF™ 1Cystic FibrosisDrug: BI 1265162;Drug: PlaceboBoehringer IngelheimNULLTerminated12 YearsN/AAll52Phase 2United States;Belgium;Canada;France;Germany;Spain;Sweden;United Kingdom
4EUCTR2019-000261-21-IE
(EUCTR)
26/07/201930/05/2019A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler - BALANCE - CF(TM)1A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis - BALANCE - CF(TM)1 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 Name: BI 1265162 10 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 25 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 50 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 100 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Boehringer Ingelheim LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
98 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Ireland;Germany;United Kingdom;Sweden
5NCT03902236
(ClinicalTrials.gov)
March 1, 20191/4/2019Reaction Time and Postural Control in Individuals With Cystic Fibrosis and BronchiectasisEvaluation of Reaction Time and Postural Control in Individuals With Cystic Fibrosis and BronchiectasisCystic Fibrosis;BronchiectasisOther: Reaction Time and Postural Control;Other: Muscle oxygenation;Other: Exercise capacity;Other: BalanceHacettepe UniversityNULLRecruiting6 Years18 YearsAll60Turkey
6NCT01759342
(ClinicalTrials.gov)
April 200821/12/2012Comprehensive Exercise Training Program During Hospitalization for an Acute CF ExacerbationThe Efficacy of a Standardized Exercise Protocol in Inpatient Care of Patients With Cystic FibrosisCystic FibrosisBehavioral: Aerobic exercise;Behavioral: Resistance exercise;Behavioral: Flexibility and postural exercise;Behavioral: Balance exerciseUniversity of Alabama at BirminghamNULLCompleted6 Years21 YearsBoth23N/AUnited States
7NCT00023465
(ClinicalTrials.gov)
June 20016/9/2001Quantification of Pulmonary Neutrophil Activity in Cystic Fibrosis Using Radiolabeled Fluorodeoxyglucose and PET ImagingQuantification of Pulmonary Neutrophil Activity in Cystic Fibrosis Using Radiolabeled Fluorodeoxyglucose and PET ImagingCystic FibrosisProcedure: FDG-PET;Procedure: spirometry;Procedure: bronchoscopy with BALNational Center for Research Resources (NCRR)NULLRecruiting18 YearsN/AFemale10N/AUnited States