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
| 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 | EUCTR2019-000261-21-GB (EUCTR) | 05/11/2019 | 05/06/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler - BALANCE - CF(TM) 1 | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | Sweden;United Kingdom;Germany;Ireland;Belgium;Spain;Canada;France;United States | ||
| 2 | EUCTR2019-000261-21-BE (EUCTR) | 07/10/2019 | 29/05/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler – BALANCE – CF(TM)1 | A 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.V | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden | ||
| 3 | NCT04059094 (ClinicalTrials.gov) | September 16, 2019 | 15/8/2019 | A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat® Inhaler - BALANCE - CF™1 | A 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™ 1 | Cystic Fibrosis | Drug: BI 1265162;Drug: Placebo | Boehringer Ingelheim | NULL | Terminated | 12 Years | N/A | All | 52 | Phase 2 | United States;Belgium;Canada;France;Germany;Spain;Sweden;United Kingdom |
| 4 | EUCTR2019-000261-21-IE (EUCTR) | 26/07/2019 | 30/05/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler - BALANCE - CF(TM)1 | A 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 Limited | NULL | Authorised-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): no | France;United States;Canada;Belgium;Spain;Ireland;Germany;United Kingdom;Sweden | ||
| 5 | NCT03902236 (ClinicalTrials.gov) | March 1, 2019 | 1/4/2019 | Reaction Time and Postural Control in Individuals With Cystic Fibrosis and Bronchiectasis | Evaluation of Reaction Time and Postural Control in Individuals With Cystic Fibrosis and Bronchiectasis | Cystic Fibrosis;Bronchiectasis | Other: Reaction Time and Postural Control;Other: Muscle oxygenation;Other: Exercise capacity;Other: Balance | Hacettepe University | NULL | Recruiting | 6 Years | 18 Years | All | 60 | Turkey | |
| 6 | NCT01759342 (ClinicalTrials.gov) | April 2008 | 21/12/2012 | Comprehensive Exercise Training Program During Hospitalization for an Acute CF Exacerbation | The Efficacy of a Standardized Exercise Protocol in Inpatient Care of Patients With Cystic Fibrosis | Cystic Fibrosis | Behavioral: Aerobic exercise;Behavioral: Resistance exercise;Behavioral: Flexibility and postural exercise;Behavioral: Balance exercise | University of Alabama at Birmingham | NULL | Completed | 6 Years | 21 Years | Both | 23 | N/A | United States |
| 7 | NCT00023465 (ClinicalTrials.gov) | June 2001 | 6/9/2001 | Quantification of Pulmonary Neutrophil Activity in Cystic Fibrosis Using Radiolabeled Fluorodeoxyglucose and PET Imaging | Quantification of Pulmonary Neutrophil Activity in Cystic Fibrosis Using Radiolabeled Fluorodeoxyglucose and PET Imaging | Cystic Fibrosis | Procedure: FDG-PET;Procedure: spirometry;Procedure: bronchoscopy with BAL | National Center for Research Resources (NCRR) | NULL | Recruiting | 18 Years | N/A | Female | 10 | N/A | United States |