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 | EUCTR2016-001440-18-NL (EUCTR) | 30/05/2018 | 16/01/2018 | The influence of cytochrome P450 3A4 inhibitors on serum levels of Ivacaftor in cystic fibrosis patients and healthy subjects. | Pharmacokinetic interactions between ivacaftor and cytochrome P450 3A4 inhibitors in cystic fibrosis patients and healthy controls - IACI | cystic fibrosis and healthy subjects;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Ivacaftor Trade Name: claritromycin 500mg film coated tablets Product Name: Claritromycin Trade Name: Azithromycin 500 mg film-coated tablet Product Name: azithromycin Trade Name: Norvir 100 mg film-coated tablets Product Name: Norvir | university medical center utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 4 | Netherlands | ||
| 2 | NCT02677701 (ClinicalTrials.gov) | October 21, 2016 | 29/1/2016 | Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic Fibrosis (CF) | TEACH Trial: Testing the Effect of Adding CHronic Azithromycin to Inhaled Tobramycin. A Randomized, Placebo-controlled, Double-blinded Trial of Azithromycin 500mg Thrice Weekly in Combination With Inhaled Tobramycin | Cystic Fibrosis | Drug: azithromycin;Drug: placebo (for azithromycin);Drug: inhaled tobramycin | Seattle Children's Hospital | National Heart, Lung, and Blood Institute (NHLBI);Cystic Fibrosis Foundation;CF Therapeutics Development Network Coordinating Center | Completed | 12 Years | N/A | All | 119 | Phase 4 | United States |
| 3 | NCT02531984 (ClinicalTrials.gov) | August 2015 | 21/8/2015 | The Efficacy of Azithromycin in Treating Children With Non Cystic Fibrosis Bronchiectasis | Open Trial With Randomized Withdrawal of Treatment, to Evaluate the Efficacy of Azithromycin in the Treatment of Children With Non Cystic Fibrosis Bronchiectasis ( AZI-STOP Study ) | Non Cystic Fibrosis Bronchiectasis in Children | Drug: Azithromycin | Assistance Publique Hopitaux De Marseille | NULL | Active, not recruiting | 3 Years | 17 Years | Both | 100 | Phase 3 | NULL |
| 4 | NCT02372383 (ClinicalTrials.gov) | October 2014 | 20/6/2014 | Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis | Pharmacokinetic Evaluation of Nontuberculous Mycobacterial Antibiotics in Cystic Fibrosis Versus Controls | Cystic Fibrosis | Drug: Ethambutol;Drug: Rifampin;Drug: Azithromycin;Drug: Pancrelipase | University of Colorado, Denver | Cystic Fibrosis Foundation Therapeutics;Colorado Clinical & Translational Sciences Institute | Completed | 16 Years | 45 Years | Both | 32 | N/A | United States |
| 5 | NCT02803944 (ClinicalTrials.gov) | September 2014 | 14/6/2016 | Continuous Azithromycin in Cystic Fibrosis Patients Beyond Two Years | Long Term Effects of Azithromycin in Patients With Cystic Fibrosis Using the National Database | Cystic Fibrosis | Drug: Azithromycin | Hospices Civils de Lyon | NULL | Completed | 7 Years | N/A | Both | 2055 | N/A | France |
| 6 | NCT02054156 (ClinicalTrials.gov) | June 2014 | 1/2/2014 | OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis | OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis: The OPTIMIZE Multicenter, Placebo-Controlled, Double-Blind, Randomized Trial | Cystic Fibrosis | Drug: azithromycin;Drug: placebo;Drug: Tobramycin solution for inhalation | Bonnie Ramsey | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 6 Months | 18 Years | All | 221 | Phase 3 | United States |
| 7 | NCT01270074 (ClinicalTrials.gov) | April 2012 | 23/12/2010 | Prevention of Bronchiectasis in Infants With Cystic Fibrosis | A Phase 3 Multi-centre Randomised Placebo-controlled Study of Azithromycin in the Primary Prevention of Radiologically-defined Bronchiectasis in Infants With Cystic Fibrosis. | Cystic Fibrosis;Bronchiectasis | Drug: Azithromycin;Drug: Placebo control | The University of Queensland | Telethon Kids Institute | Completed | 6 Weeks | 6 Months | All | 130 | Phase 3 | Australia;New Zealand |
| 8 | NCT03045198 (ClinicalTrials.gov) | March 2012 | 2/2/2017 | Effect of Azithromycin on Fatty Acids in CF | Effect of Azithromycin on Lipoproteins and Docosahexaenoic Acid in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Azithromycin | University Childrens' Hospital (Zentrum für Kinderheilkunde des Universitätsklinikum Bonn) | University of Bonn;University Hospital, Frankfurt | Unknown status | 10 Years | 60 Years | All | 20 | Phase 4 | NULL |
| 9 | EUCTR2006-003275-12-NO (EUCTR) | 03/06/2009 | 27/03/2009 | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Zitromax Product Name: Zitromax Product Code: Zitromax INN or Proposed INN: AZITHROMYCIN Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN | Copenhagen CF-centre | NULL | NA | Female: yes Male: yes | 250 | Phase 4 | Denmark;Norway;Sweden | ||
| 10 | NCT00411736 (ClinicalTrials.gov) | May 2008 | 14/12/2006 | Scandinavian Cystic Fibrosis Azithromycin Study | Supplementary Oral Azithromycin in Treatment of Intermittent Pseudomonas Aeruginosa Colonization in CF-patients With Inhaled Colistin and Oral Ciprofloxacin; Postponing Next Isolate of Pseudomonas and Prevention of Chronic Infection. A Prospective, Double-blinded, Placebo-controlled Scandinavian Multi-centre Study. | Cystic Fibrosis | Drug: Study medication, azithromycin or placebo;Drug: Azithromycin or placebo tablets | Rigshospitalet, Denmark | Cystic Fibrosis Foundation Therapeutics | Completed | 1 Year | N/A | Both | 45 | Phase 4 | Denmark;Norway;Sweden |
| 11 | EUCTR2006-003275-12-DK (EUCTR) | 23/05/2007 | 17/04/2007 | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN | Copenhagen CF-centre | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Denmark | ||
| 12 | NCT00431964 (ClinicalTrials.gov) | February 2007 | 2/2/2007 | Effect of Azithromycin on Lung Function in 6-18 Year-olds With Cystic Fibrosis (CF) Not Infected With P. Aeruginosa | Multi-center, Multi-national, Randomized, Placebo-Controlled Trial of Azithromycin in Subjects With Cystic Fibrosis 6-18 Years Old, Culture Negative for Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: azithromycin 250 mg tablets;Drug: placebo tablets | CF Therapeutics Development Network Coordinating Center | Cystic Fibrosis Foundation Therapeutics | Completed | 6 Years | 18 Years | All | 263 | Phase 4 | United States;Canada |
| 13 | NCT01463371 (ClinicalTrials.gov) | October 2006 | 28/10/2011 | Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With Bronchiectasis | Effects of Long-Term Azithromycin Treatment on Airway Oxidative Stress Markers in Patients With Stable Non-Cystic Fibrosis Bronchiectasis | Bronchiectasis | Drug: Azithromycin | Instituto de Investigacion Sanitaria La Fe | Sociedad Valenciana de Neumología | Completed | 16 Years | 80 Years | Both | 30 | N/A | Spain |
| 14 | NCT00298922 (ClinicalTrials.gov) | February 2006 | 2/3/2006 | Azithromycin in Patients With CF, Infected With Burkholderia Cepacia Complex | Phase II, Randomized, Double Blind, Placebo-Controlled Trial of Azithromycin in Patients With CF, Chronically Infected With Burkholderia Cepacia Complex | Cystic Fibrosis | Drug: Azithromycin;Drug: Placebo | St. Michael's Hospital, Toronto | Cystic Fibrosis Foundation Therapeutics;Pfizer | Active, not recruiting | 19 Years | N/A | Both | 45 | Phase 2 | Canada |
| 15 | NCT00153634 (ClinicalTrials.gov) | March 2004 | 8/9/2005 | Standard vs. Biofilm Susceptibility Testing in Cystic Fibrosis (CF) | Standard vs. Biofilm Susceptibility Testing in CF | Cystic Fibrosis;Chronic Bronchitis | Drug: IV amikacin;Drug: PO azithromycin;Drug: IV ceftazidime;Drug: PO ciprofloxacin;Drug: IV meropenem;Drug: IV piperacillin-tazobactam;Drug: IV ticarcillin-clavulanate;Drug: IV tobramycin | Seattle Children's Hospital | Cystic Fibrosis Foundation Therapeutics | Completed | 14 Years | N/A | Both | 75 | N/A | United States |
| 16 | EUCTR2006-003275-12-SE (EUCTR) | 07/07/2009 | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Trade Name: Azithromycin Product Name: azithromycin Product Code: azithromycin INN or Proposed INN: AZITHROMYCIN Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN | Copenhagen CF-centre | NULL | NA | Female: yes Male: yes | 250 | Phase 4 | Denmark;Norway;Sweden | |||
| 17 | EUCTR2014-003023-22-FR (EUCTR) | 22/06/2015 | Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study) | Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study) - AZI-STOP study | bronchiectasis excluding cystic fibrosis in children;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: ZITHOMAX 40 mg/ml ENFANTS Product Name: zithromax INN or Proposed INN: AZITHROMYCIN DIHYDRATE Trade Name: ZITHROMAX 250 mg Product Name: ZITHROMAX INN or Proposed INN: AZITHROMYCIN DIHYDRATE | ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | France |