299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
| 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 | EUCTR2016-004558-13-DE (EUCTR) | 01/12/2020 | 09/04/2020 | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;France;United States;Greece;Canada;Argentina;Poland;Germany;Italy | ||
| 2 | EUCTR2016-004558-13-PT (EUCTR) | 27/07/2020 | 20/04/2020 | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | France;United States;Portugal;Greece;Canada;Argentina;Poland;Germany;Italy | ||
| 3 | EUCTR2016-004558-13-GR (EUCTR) | 07/07/2020 | 14/05/2020 | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;France;United States;Canada;Greece;Argentina;Poland;Australia;Israel;Germany;Italy;New Zealand | ||
| 4 | EUCTR2016-004558-13-PL (EUCTR) | 14/08/2017 | 30/06/2017 | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;France;Canada;Greece;Argentina;Poland;Australia;Israel;Germany;New Zealand;Italy | ||
| 5 | EUCTR2016-004558-13-FR (EUCTR) | 30/05/2017 | 20/03/2017 | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 19.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 3 | Portugal;United States;France;Greece;Canada;Poland;Germany;Italy |