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 | EUCTR2011-002000-32-HU (EUCTR) | 25/11/2011 | 05/09/2011 | A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | A single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler 28 mg inhalációs por, kemény kapszula Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | France;United States;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy | ||
| 2 | EUCTR2011-002000-32-ES (EUCTR) | 17/11/2011 | 28/09/2011 | A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | A single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis - not available | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI PODHALER Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Farmaceutica S. A | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;France;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy | ||
| 3 | EUCTR2009-016734-26-BG (EUCTR) | 01/07/2010 | 15/06/2010 | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Estonia;Lithuania;Bulgaria;Latvia | ||
| 4 | EUCTR2009-016734-26-LT (EUCTR) | 23/03/2010 | 20/01/2010 | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Estonia;Lithuania;Bulgaria;Latvia | ||
| 5 | EUCTR2009-016734-26-LV (EUCTR) | 17/02/2010 | 11/01/2010 | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania | ||
| 6 | EUCTR2009-016734-26-EE (EUCTR) | 08/01/2010 | 15/12/2009 | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Estonia;Lithuania;Bulgaria;Latvia | ||
| 7 | EUCTR2008-002318-22-LT (EUCTR) | 07/09/2009 | 22/01/2009 | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin Other descriptive name: TBM100C | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania | ||
| 8 | EUCTR2008-004764-39-LT (EUCTR) | 07/09/2009 | 22/01/2009 | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 13.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania | ||
| 9 | EUCTR2008-004764-39-BG (EUCTR) | 20/08/2009 | 28/08/2009 | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 12.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Estonia;Bulgaria;Latvia;Lithuania | ||
| 10 | EUCTR2008-002318-22-BG (EUCTR) | 20/08/2009 | 28/08/2009 | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Estonia;Bulgaria;Latvia;Lithuania | ||
| 11 | EUCTR2008-004764-39-EE (EUCTR) | 30/07/2009 | 23/07/2009 | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania | ||
| 12 | EUCTR2008-004764-39-LV (EUCTR) | 19/06/2009 | 08/05/2009 | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania | ||
| 13 | EUCTR2008-002318-22-LV (EUCTR) | 13/05/2009 | 28/01/2009 | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania | ||
| 14 | EUCTR2008-002318-22-EE (EUCTR) | 06/05/2009 | 27/02/2009 | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania | ||
| 15 | EUCTR2011-002000-32-FR (EUCTR) | 22/09/2011 | A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | A single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100 INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | NA | Female: yes Male: yes | 150 | Phase 4 | United States;France;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy |