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 | EUCTR2015-003040-39-NL (EUCTR) | 28/08/2017 | 23/01/2017 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection | Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Belgium;Spain;Ireland;Germany;Netherlands;Italy;United Kingdom;Switzerland | ||
| 2 | NCT02712983 (ClinicalTrials.gov) | February 8, 2017 | 5/2/2016 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A Randomized, Blinded, Parallel Group, Multi-center Dose-finding Study, to Assess the Efficacy, Safety and Tolerability of Different Doses of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | Non-cystic Fibrosis Bronchiectasis | Drug: TIP;Drug: TIP and placebo;Drug: Placebo | Novartis Pharmaceuticals | Queen's University Belfast, UK;University Hospital Antwerp, BE;University of Milan, IT;Fundacion Clinic per a la Recerca Biomedica;Erasmus Medical Center;Papworth Hospital Cambridge, UK;Royal Brompton Hospital Trust, UK;University of Dundee;University of Edinburgh, UK | Completed | 18 Years | N/A | All | 107 | Phase 2 | Belgium;France;Germany;Italy;Spain;United Kingdom;Netherlands |
| 3 | EUCTR2015-003040-39-BE (EUCTR) | 27/12/2016 | 01/09/2016 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection | Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Spain;Belgium;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 4 | EUCTR2015-003040-39-DE (EUCTR) | 23/12/2016 | 11/10/2016 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection | Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 5 | EUCTR2015-003040-39-IE (EUCTR) | 16/12/2016 | 16/12/2016 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection | Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 6 | EUCTR2015-003040-39-FR (EUCTR) | 16/12/2016 | 21/09/2018 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection | Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 7 | EUCTR2015-003040-39-GB (EUCTR) | 18/10/2016 | 30/01/2017 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection | Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;Switzerland;United Kingdom | ||
| 8 | EUCTR2015-003040-39-ES (EUCTR) | 29/09/2016 | 30/08/2016 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection | Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.0;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 9 | EUCTR2015-003040-39-IT (EUCTR) | 14/09/2016 | 28/09/2018 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection - Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder i | Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.1;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: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE Product Name: Tobramicina polvere inalatoria Product Code: TBM100 INN or Proposed INN: TOBRAMICINA Other descriptive name: TOBRAMICINA Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE Product Name: Tobramicina polvere inalatoria Product Code: TBM100 INN or Proposed INN: TOBRAMICINA Other descriptive name: TOBRAMICINA Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE Product Name: Tobramicina polvere inalatoria Product Code: TBM100 INN or Proposed INN: TOBRAMICINA Other descriptive name: TOBRAMICINA | NOVARTIS PHARMA SERVICES AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 10 | NCT02449031 (ClinicalTrials.gov) | May 5, 2015 | 4/5/2015 | Observational Study in Cystic Fibrosis Patients Using TOBI® Podhaler™ or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs | A Prospective Observational Study in Cystic Fibrosis Patients With Chronic Respiratory Pseudomonas Aeruginosa Infection Treated With TOBI® Podhaler™ (Tobramycin Inhalation Powder) or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs | Pseudomonas Aeruginosa in Cystic Fibrosis | Drug: TOBI Podhaler;Drug: TOBI;Drug: Bethkis;Drug: Cayston | Mylan Inc. | Cystic Fibrosis Foundation | Active, not recruiting | 6 Years | N/A | All | 260 | United States | |
| 11 | 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 | ||
| 12 | NCT02212587 (ClinicalTrials.gov) | September 2014 | 6/8/2014 | Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex | Pilot Study of the in Vivo Efficacy of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex | Cystic Fibrosis;Burkholderia Cepacia Infection | Drug: TOBI | St. Michael's Hospital, Toronto | NULL | Completed | 6 Years | N/A | All | 10 | Phase 1 | Canada |
| 13 | NCT02113397 (ClinicalTrials.gov) | April 2014 | 9/4/2014 | Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis Lung | Comparative Evaluation of Bacterial Diversity and Richness in CF Lung in Patients Who Use Cycled Every Other Month Tobramycin Inhalation Powder (TOBI™ Podhaler™) Or Continuous Alternating Therapy With Tobramycin Inhalation Powder (TOBI™ Podhaler™) and Inhaled Colistimethate | Cystic Fibrosis | Drug: TOBI™ Podhaler™ 112 mg inhaled twice daily;Drug: Colistimethate 75 mg inhaled two times daily | Dartmouth-Hitchcock Medical Center | Novartis Pharmaceuticals | Terminated | 12 Years | 75 Years | All | 1 | United States | |
| 14 | NCT02015663 (ClinicalTrials.gov) | January 2014 | 13/12/2013 | Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles | A 24-week, Open-label, Parallel-group, Interventional Phase IV Study Comparing Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles for the Treatment of Pulmonary Pseudomonas Aeruginosa in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Tobramycin Inhalation Powder | Novartis Pharmaceuticals | NULL | Terminated | 6 Years | N/A | All | 32 | Phase 4 | United States |
| 15 | NCT01844778 (ClinicalTrials.gov) | August 2013 | 29/4/2013 | Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI) | An Open-label, Crossover, Interventional Phase IV Study to Compare the Ease of Use of TIP With Nebulized TIS and Nebulized COLI for the Treatment of Pulmonary Pseudomonas Aeruginosa (P.a) in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Tobramycin Inhalation Powder;Drug: Tobramycin inhalation solution;Drug: Colistimethate | Novartis Pharmaceuticals | NULL | Completed | 6 Years | N/A | All | 60 | Phase 4 | Germany;Ireland;Spain;Switzerland;United Kingdom |
| 16 | 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 | ||
| 17 | EUCTR2012-001565-33-GB (EUCTR) | 21/06/2013 | 16/04/2013 | 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: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 17.1;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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Spain;Ireland;Germany;Switzerland;United Kingdom | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | NCT01775137 (ClinicalTrials.gov) | February 2013 | 22/1/2013 | Ext. Long-term Safety Study in CF Patients: Single Arm TIP | A 48 Week Extension to CTBM100C2401, a Single Arm, Open-label, Multicenter, Phase IV Extension Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis Who Completed Participation in CTBM100C2401. | Long-term Safety of TIP | Drug: TBM100 | Novartis Pharmaceuticals | NULL | Completed | 6 Years | N/A | All | 45 | Phase 4 | United States;Argentina;Australia;Canada;Germany;Hungary;Italy;Mexico;Spain |
| 21 | 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 | ||
| 22 | EUCTR2012-003532-23-IT (EUCTR) | 18/01/2013 | 21/12/2012 | 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 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Classification code 10011762;Term: Cystic fibrosis;Level: HLT;Classification code 10037132;Term: Pseudomonal infections;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI PODHALER*448CPS 28MG+10IN INN or Proposed INN: Tobramycin | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy | ||
| 23 | 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 | ||
| 24 | 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 | ||
| 25 | NCT01519661 (ClinicalTrials.gov) | January 2012 | 24/1/2012 | Long Term Safety of Tobramycin Inhalation Powder 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 | Pulmonary Infections;Pseudomonas Aeruginosa in Cystic Fibrosis | Drug: TBM100 | Novartis Pharmaceuticals | NULL | Completed | 6 Years | N/A | All | 157 | Phase 4 | United States;Argentina;Australia;Canada;France;Germany;Hungary;Italy;Mexico;Spain;Brazil |
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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 | ||
| 30 | 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 | ||
| 31 | 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 | ||
| 32 | 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 | ||
| 33 | NCT01069705 (ClinicalTrials.gov) | February 2010 | 15/2/2010 | Second Open Label Extension to Bridging 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) Patients Who Completed Participation in Study CTBM100C2303E1. | Pulmonary Infections;Pseudomonas Aeruginosa | Drug: Tobramycin inhalation powder | Novartis Pharmaceuticals | NULL | Completed | 6 Years | 21 Years | All | 49 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania;Romania;Russian Federation;South Africa |
| 34 | 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 | ||
| 35 | 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 | ||
| 36 | 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 | ||
| 37 | 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 | ||
| 38 | 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 | ||
| 39 | NCT00982930 (ClinicalTrials.gov) | August 2009 | 21/9/2009 | Open Label Extension to Bridging 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;Cystic Fibrosis | Drug: Tobramycin inhalation powder | Novartis Pharmaceuticals | NULL | Completed | 6 Years | 21 Years | Both | 57 | Phase 3 | Estonia;Russian Federation |
| 40 | 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 | ||
| 41 | 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 | ||
| 42 | NCT00918957 (ClinicalTrials.gov) | June 2009 | 4/6/2009 | A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo | 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). | Cystic Fibrosis | Drug: Tobramycin Inhalation Powder;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 6 Years | 21 Years | All | 62 | Phase 3 | Bulgaria;Egypt;Estonia;India;Latvia;Lithuania;Romania;Russian Federation;South Africa |
| 43 | 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 | ||
| 44 | 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 | ||
| 45 | 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 | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Greece;Spain;Ireland;Germany;Italy;United Kingdom | ||
| 46 | 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 | ||
| 47 | EUCTR2005-003772-37-IT (EUCTR) | 28/02/2006 | 23/06/2006 | A randomized, open label, multicentre, phase 3 trial to assess the safety of Tobramycin Inhalation Powder compared to TOBI in cystic fibrosis subjects - TIP003 | A randomized, open label, multicentre, phase 3 trial to assess the safety of Tobramycin Inhalation Powder compared to TOBI in cystic fibrosis subjects - TIP003 | Cystic Fibrosis with presence of Pseudomonas aeruginosa infection MedDRA version: 6.1;Level: PT;Classification code 10011763 | INN or Proposed INN: Tobramycin Product Name: Tobramycin Inhalation Powder TIP delivered by the T-326 Inhaler Product Code: T-326 INN or Proposed INN: Tobramycin | CHIRON CORPORATION LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Germany;United Kingdom;Spain;Italy;Greece | ||
| 48 | EUCTR2005-003772-37-ES (EUCTR) | 09/02/2006 | 20/01/2006 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects Estudio aleatorizado, abierto, multicéntrico, fase III para evaluar la seguridad de Tobramicina polvo inhalatorio comparado con TOBI en pacientes con fibrosis quística. | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects Estudio aleatorizado, abierto, multicéntrico, fase III para evaluar la seguridad de Tobramicina polvo inhalatorio comparado con TOBI en pacientes con fibrosis quística. | Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762 | Product Name: Tobramycin Inhalation Powder Product Code: TIP INN or Proposed INN: Tobramycin Trade Name: TOBI 300mg/5mL Nebuliser Solution Product Name: TOBI INN or Proposed INN: Tobramycin | Chiron Corporation Ltd | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Greece;Spain;Germany;Italy;United Kingdom | ||
| 49 | NCT00388505 (ClinicalTrials.gov) | February 2006 | 16/10/2006 | Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis | A Randomized, Open-label Multicentre Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to Tobramycin Solution for Inhalation in Cystic Fibrosis Subjects | Cystic Fibrosis | Drug: Tobramycin Inhalation Powder;Drug: Tobramycin Solution for Inhalation | Novartis Pharmaceuticals | NULL | Completed | 6 Years | N/A | All | 517 | Phase 3 | United States;Australia;Canada;Chile;Colombia;France;Germany;Hungary;Israel;Italy;Mexico;Netherlands;Spain;United Kingdom |
| 50 | 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 | ||
| 51 | EUCTR2005-002035-28-LT (EUCTR) | 19/09/2005 | 24/08/2005 | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects | pulmonary P aeruginosa infection in patient with cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Tobramycin Inhalation Powder Product Code: TIP INN or Proposed INN: Tobramycine | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Lithuania | ||
| 52 | NCT00125346 (ClinicalTrials.gov) | September 2005 | 28/7/2005 | Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects | Cystic Fibrosis | Drug: Tobramycin Inhalation Powder | Novartis | NULL | Terminated | 6 Years | 21 Years | Both | 98 | Phase 3 | United States;Argentina;Brazil;Bulgaria;Canada;Chile;Lithuania;Mexico;Former Serbia and Montenegro |
| 53 | EUCTR2005-003772-37-DE (EUCTR) | 05/12/2005 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects | Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762 | Product Name: Tobramycin Inhalation Powder Product Code: TIP INN or Proposed INN: Tobramycin Product Name: TOBI INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;United Kingdom;Germany;Spain;Italy;Greece | |||
| 54 | 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 | |||
| 55 | EUCTR2016-004318-82-Outside-EU/EEA (EUCTR) | 15/05/2017 | A study comparing Tobramycin Inhalation Powder (TIP) administered once daily continuously versus TIP administered BID in 28 day on / 28 day off cycles for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis | Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: TOBI Podhaler INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharmaceuticals Corporation | NULL | NA | Female: yes Male: yes | 200 | Phase 4 | United States | |||
| 56 | EUCTR2016-001840-20-Outside-EU/EEA (EUCTR) | 18/05/2016 | Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients | A Multi-center, Human Factors Engineering (HFE) Usability Study in Cystic Fibrosis Patients to Validate the Approved Instructions for Use (IFU) of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo Capsules. | cystic fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler | Novartis Pharmaceuticals Corporation | NULL | NA | Female: yes Male: yes | 45 | Phase 4 | United States |