Tbm100c (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 | 27 |
| 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 | EUCTR2012-001565-33-IE (EUCTR) | 08/01/2015 | 11/09/2014 | An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistin | An open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis | Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 17.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Colistimethate Other descriptive name: COLISTIMETHATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 67 | Phase 4 | Spain;Ireland;Germany;United Kingdom;Switzerland | ||
| 2 | EUCTR2014-001204-21-DE (EUCTR) | 17/11/2014 | 22/08/2014 | An open-label clinical trial that evaluates the lung clearance index in cystic fibrosis patients = 6 years of age, chronically infected with Pseudomonas aeruginosa | An 8 week open-label interventional multicenter study to evaluate the lung clearance index as endpoint for clinical trials in cystic fibrosis patients = 6 years of age, chronically infected with Pseudomonas aeruginosa | Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 18.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Germany | |||
| 3 | EUCTR2012-001565-33-ES (EUCTR) | 04/07/2013 | 16/05/2013 | An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistin | An open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis | Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 16.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN Trade Name: TOBI 300 mg/5 ml solución para inhalación por nebulizador INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN Trade Name: Promixin,1 millón de Unidades Internacionales,polvo para solución para inhalación por nebulizador INN or Proposed INN: Colistimethate Other descriptive name: COLISTIMETHATE | Novartis Farmaceutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 67 | Phase 4 | Spain;Ireland;Germany;United Kingdom;Switzerland | ||
| 4 | EUCTR2012-003532-23-DE (EUCTR) | 20/06/2013 | 05/02/2013 | An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | A 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 15.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 15.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | France;United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy | ||
| 5 | EUCTR2012-001565-33-DE (EUCTR) | 05/06/2013 | 18/04/2013 | An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistin | An open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis | Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 18.1;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Colistimethate Other descriptive name: COLISTIMETHATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 67 | Phase 4 | Spain;Ireland;Germany;United Kingdom;Switzerland | ||
| 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 |
| 6 | EUCTR2012-003532-23-ES (EUCTR) | 29/01/2013 | 29/11/2012 | An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | A 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Farmaceutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | France;United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy | ||
| 7 | EUCTR2012-003532-23-HU (EUCTR) | 19/12/2012 | 31/10/2012 | An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | A 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | France;United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy | ||
| 8 | EUCTR2011-002000-32-IT (EUCTR) | 09/02/2012 | 06/03/2012 | 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 to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Tobramycin inhalation powder Product Code: TBM100C INN or Proposed INN: TOBRAMYCIN Other descriptive name: NA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Hungary;Mexico;Canada;Argentina;Spain;Brazil;Australia;Germany;Italy | ||
| 9 | EUCTR2011-002000-32-DE (EUCTR) | 13/12/2011 | 31/10/2011 | 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 Hartkapseln mit Pulver zur Inhalation Product Name: TOBI Podhaler 28 mg Hartkapseln mit Pulver zur Inhalation 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 | ||
| 10 | 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 | ||
| 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 |
| 11 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | Hungary;Germany;Canada;Mexico;Argentina;France;Spain;Italy;United States;Brazil;Australia | ||
| 12 | EUCTR2005-003772-37-IE (EUCTR) | 26/07/2011 | 08/07/2008 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003 | Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762 | Product Name: Tobramycin Inhalation Powder (TIP) Product Code: TBM100C INN or Proposed INN: Tobramycin Trade Name: TOBI Product Name: TOBI INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Greece;Spain;Ireland;Germany;Italy;United Kingdom | ||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 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 |
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 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 |
| 21 | 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 | ||
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | 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 | ||
| 25 | EUCTR2005-003772-37-GR (EUCTR) | 03/06/2008 | 21/01/2008 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - ASPIRE II | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - ASPIRE II | Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762 | Product Name: Tobramycin Inhalation Powder (TIP) Product Code: TBM100C INN or Proposed INN: Tobramycin Trade Name: TOBI Product Name: TOBI INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | Hungary;Germany;United Kingdom;Spain;Italy;Greece | ||
| 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 |
| 26 | EUCTR2005-003772-37-HU (EUCTR) | 08/11/2007 | 03/07/2007 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003 | Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762 | Product Name: Tobramycin Inhalation Powder (TIP) Product Code: TBM100C INN or Proposed INN: Tobramycin Trade Name: TOBI Product Name: TOBI INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Germany;United Kingdom;Spain;Italy;Greece | ||
| 27 | EUCTR2005-003772-37-GB (EUCTR) | 06/01/2006 | 09/11/2005 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003 | Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762 | Product Name: Tobramycin Inhalation Powder (TIP) Product Code: TBM100C INN or Proposed INN: Tobramycin Trade Name: TOBI Product Name: TOBI INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Greece;Spain;Germany;Italy;United Kingdom |