Promixin, 1 million international units (iu) powder for nebuliser solution (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 299 | 嚢胞性線維症 | 5 |
| 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Portugal;United States;France;Greece;Canada;Argentina;Poland;Germany | ||
| 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 | United States;France;Portugal;Greece;Canada;Argentina;Poland | ||
| 3 | EUCTR2016-004558-13-GR (EUCTR) | 07/07/2020 | 14/05/2020 | Treatment for bronchiectasis not due to cystic fibrosis. | 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;France;Canada;Greece;Argentina;Poland | ||
| 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;France;Canada;Argentina;Poland | ||
| 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 264 | Phase 3 | United States;France;Canada;Poland |