Tobi 300 mg/5 ml, solution pour inhalation par nébuliseur (DrugBank: -)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 299 | Cystic fibrosis | 1 |
| 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 | EUCTR2010-019634-26-FR (EUCTR) | 08/02/2011 | A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy ofMP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis Patients | A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy ofMP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis Patients | Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: Aeroquin Product Code: MP-376 INN or Proposed INN: levofloxacin Other descriptive name: levofloxacin hemihydrate Trade Name: TOBI 300 mg/5 ml, solution pour inhalation par nébuliseur INN or Proposed INN: TOBRAMYCIN | Mpex Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 330 | Phase 3 | France;Ireland;Germany;United Kingdom |