299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,696 / 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
| 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 | NCT03502070 (ClinicalTrials.gov) | June 26, 2018 | 29/3/2018 | Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules | A Multicenter, Human Factors Validation Study in Cystic Fibrosis Patients Aged 6 Years and Older to Evaluate the User Interface of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo Capsules | Cystic Fibrosis | Drug: Placebo;Device: Tobi Podhaler | Mylan Inc. | NULL | Completed | 6 Years | N/A | All | 47 | Phase 4 | United States |
| 2 | 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 | ||
| 3 | NCT03066453 (ClinicalTrials.gov) | June 13, 2017 | 23/2/2017 | Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic Fibrosis | Evaluation of an Antibiotic Treatment With 14 Days of Intravenous Tobramycin Versus the Same Antibiotic Associated With 5 Days of Intravenous Tobramycin Followed by Tobramycin Aerosol for 9 Days in Cystic Fibrosis. | Cystic Fibrosis | Drug: Tobi Inhalant Product;Drug: Nebcin | University Hospital, Lille | NULL | Terminated | 8 Years | N/A | All | 23 | Phase 3 | France |
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | |
| 12 | 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 | Switzerland;United Kingdom;Germany;Ireland;Spain | ||
| 13 | 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 | |||
| 14 | 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 |
| 15 | NCT02178540 (ClinicalTrials.gov) | August 2014 | 24/6/2014 | 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 | Drug: Placebo;Device: Tobi Podhaler | Novartis Pharmaceuticals | NULL | Completed | 6 Years | N/A | All | 45 | Phase 4 | United States |
| 16 | EUCTR2013-004295-35-AT (EUCTR) | 30/04/2014 | 02/04/2014 | Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study | Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study - LCI-OUT | Chronic lung P. Aeruginosa Infection MedDRA version: 16.1;Level: PT;Classification code 10061229;Term: Lung infection;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler Product Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler INN or Proposed INN: aztreonam Other descriptive name: AZTREONAM LYSINE Trade Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel Product Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel INN or Proposed INN: COLISTIMETHATE SODIUM Trade Name: TOBI Product Name: Tobi INN or Proposed INN: TOBRAMYCIN SULFATE | Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III) | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 4 | Austria | ||
| 17 | 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 | |
| 18 | EUCTR2009-016590-15-PL (EUCTR) | 03/12/2013 | 11/10/2013 | A clinical trial to assess the treatment with nebulised tobramycin in terms of safety and ability to kill Pseudomonas bacteria in the lungs of cystic fibrosis patients aged 3 months to 6 years included | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacyand Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P.aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. | Lung colonisation 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 10068292;Term: Pseudomonas colonization;System Organ Class: 100000004862 MedDRA version: 14.1;Classification code 10068297;Term: Pseudomonas colonisation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI 300 mg / 5 mL nebuliser solution INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | United States;Greece;Russian Federation;Switzerland;Italy;France;Egypt;Hungary;Canada;Argentina;Poland;Romania;Germany | |||
| 19 | NCT01953367 (ClinicalTrials.gov) | September 2013 | 4/9/2013 | Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects | Bioequivalence and Safety Study of Vantobra and TOBI Nebulizer Solutions in Healthy Subjects | Cystic Fibrosis | Drug: Vantobra (tobramycin);Drug: TOBI (tobramycin) | Pari Pharma GmbH | NULL | Completed | 18 Years | 50 Years | Both | 72 | Phase 1 | Germany |
| 20 | 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 | ||
| 21 | 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 | ||
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | 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 | ||
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | EUCTR2011-000441-20-NL (EUCTR) | 11/09/2012 | 06/07/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany;United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom | |||
| 28 | EUCTR2011-000441-20-BG (EUCTR) | 13/06/2012 | 03/05/2012 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Serbia;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
| 29 | EUCTR2011-000441-20-IE (EUCTR) | 02/05/2012 | 26/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Code: TOBI INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 30 | EUCTR2011-000441-20-DK (EUCTR) | 29/03/2012 | 22/07/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
| 31 | EUCTR2011-000441-20-BE (EUCTR) | 30/01/2012 | 25/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) Product Code: N/A INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Name: TOBI Product Code: N/A INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany | ||
| 32 | 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 | ||
| 33 | 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 | ||
| 34 | 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 | ||
| 35 | EUCTR2011-000441-20-IT (EUCTR) | 01/10/2011 | 08/03/2012 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection/colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) Product Code: NA INN or Proposed INN: AMIKACIN SULFATE Trade Name: Tobi INN or Proposed INN: TOBRAMYCIN | INSMED INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Greece;Canada;Spain;Ireland;Denmark;Austria;Bulgaria;Netherlands;United Kingdom;Italy | |||
| 36 | EUCTR2011-000441-20-ES (EUCTR) | 21/09/2011 | 11/11/2011 | ESTUDIO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA | ESTUDIO ALEATORIZADO, ABIERTO, CONTROLADO CON MEDICAMENTO ACTIVO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA - TR02-108 | Infección pulmonar con Pseudomonas aeruginosa/ colonización en pacientes con fibrosis quística MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Amikacina liposomal (Arikace?) INN or Proposed INN: Sulfato de amikacina Trade Name: TOBI 300mg/ 5ml solución para inhalación con nebulizador INN or Proposed INN: tobramicina | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;Netherlands | ||
| 37 | EUCTR2011-000441-20-DE (EUCTR) | 19/09/2011 | 30/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Name: TOBI INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
| 38 | EUCTR2010-019634-26-GB (EUCTR) | 18/08/2011 | 07/02/2011 | Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients | A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution (TIS) in Stable Cystic Fibrosis Patients | Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders 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] | Product Name: Aeroquin Product Code: MP-376 INN or Proposed INN: levofloxacin Other descriptive name: levofloxacin hemihydrate Trade Name: Tobi 300 mg/5 ml Nebuliser Solution INN or Proposed INN: TOBRAMYCIN | Mpex Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Ireland;Israel;Germany;United Kingdom | ||
| 39 | EUCTR2011-000441-20-GB (EUCTR) | 03/08/2011 | 24/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 40 | 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 | ||
| 41 | EUCTR2011-000441-20-AT (EUCTR) | 19/07/2011 | 21/06/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 42 | EUCTR2011-000441-20-GR (EUCTR) | 15/07/2011 | 22/06/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 43 | EUCTR2011-000441-20-SK (EUCTR) | 04/07/2011 | 25/11/2014 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
| 44 | EUCTR2009-016590-15-IT (EUCTR) | 01/07/2011 | 14/03/2012 | Evaluation of the efficacy and safety of tobramycin for the treatment of early infections of P. aeruginosa in cystic fibrosis subjects aged from 3 months to less than 7 years. | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. | Lung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients. 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] | Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML INN or Proposed INN: TOBRAMYCIN Other descriptive name: NA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 72 | France;Hungary;Greece;Canada;Poland;Russian Federation;Germany;Switzerland;Italy | |||
| 45 | EUCTR2011-000441-20-HU (EUCTR) | 29/06/2011 | 20/04/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 46 | EUCTR2010-019634-26-DE (EUCTR) | 24/05/2011 | 25/01/2011 | Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients | A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution (TIS) in Stable Cystic Fibrosis Patients | Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders 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] | Product Name: Aeroquin Product Code: MP-376 INN or Proposed INN: levofloxacin Other descriptive name: levofloxacin hemihydrate Trade Name: TOBI 300 mg/5 ml Lösung für einen INN or Proposed INN: TOBRAMYCIN | Mpex Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | France;United States;Canada;Ireland;Israel;Germany;United Kingdom | ||
| 47 | EUCTR2010-019634-26-IE (EUCTR) | 03/05/2011 | 15/02/2011 | Trial of Aeroquin versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis Patients | A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy ofMP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis Patients | Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 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] - Bacterial Infections and Mycoses [C01] | Product Name: Aeroquin Product Code: MP-376 INN or Proposed INN: levofloxacin Other descriptive name: levofloxacin hemihydrate Trade Name: TOBI INN or Proposed INN: TOBRAMYCIN | Mpex Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | France;United States;Canada;Ireland;Israel;Germany;United Kingdom | ||
| 48 | NCT01337219 (ClinicalTrials.gov) | April 2011 | 13/4/2011 | Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic Fibrosis | Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaide® in Patients With Cystic Fibrosis. | Cystic Fibrosis | Drug: Tobramycin | Erempharma | University of Lyon;Epidemiologie Pharmacologie Investigation Clinique Information medicale Mere Enfant (EPICIME);Clininfo;Hospices Civils de Lyon | Recruiting | 16 Years | N/A | Both | 36 | Phase 1/Phase 2 | France |
| 49 | EUCTR2009-016590-15-DE (EUCTR) | 19/07/2010 | 15/04/2010 | A clinical trial to assess the treatment with nebulised tobramycin in terms of safety and ability to kill Pseudomonas bacteria in the lungs of cystic fibrosis patients aged 3 months to 6 years included | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacyand Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P.aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. | Lung colonisation 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 10068292;Term: Pseudomonas colonization;System Organ Class: 100000004862 MedDRA version: 14.1;Classification code 10068297;Term: Pseudomonas colonisation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI 300 mg/5 ml Lösung für einen Vernebler Product Name: TOBI Product Code: TBM100 INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | France;Egypt;Hungary;Greece;Canada;Argentina;Poland;Romania;Russian Federation;Germany;Switzerland;Italy | |||
| 50 | EUCTR2009-016590-15-GR (EUCTR) | 15/06/2010 | 31/12/2009 | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. | Lung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 12.0;Level: LLT;Classification code 10068297;Term: Pseudomonas colonisation MedDRA version: 12.0;Classification code 10068292;Term: Pseudomonas colonization | Trade Name: TOBI 300mg/5mL nebuliser solution Product Name: TOBI INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | France;Hungary;Greece;Poland;Germany;Italy | |||
| 51 | EUCTR2009-016590-15-FR (EUCTR) | 15/04/2010 | 14/12/2009 | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. | Lung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 12.0;Level: LLT;Classification code 10068297;Term: Pseudomonas colonisation MedDRA version: 12.0;Classification code 10068292;Term: Pseudomonas colonization | Trade Name: TOBI 300mg/5mL nebuliser solution Product Name: TOBI INN or Proposed INN: Tobramycin Trade Name: TOBI 300mg/5mL nebuliser solution Product Name: TOBI INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 3 | France;Hungary;Greece;Poland;Germany;Italy | ||
| 52 | NCT01082367 (ClinicalTrials.gov) | April 2010 | 5/3/2010 | Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years | Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients | Drug: TOBI;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 3 Months | 6 Years | All | 50 | Phase 3 | Canada;Egypt;France;Germany;Greece;Hungary;Italy;Romania;Russian Federation;Switzerland;Poland;United States |
| 53 | NCT01288170 (ClinicalTrials.gov) | February 2010 | 1/2/2011 | Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® | Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® | Cystic Fibrosis | Drug: Nebcinal Tobi;Drug: Tobi Nebcinal | Erempharma | Hopitaux de Lyon;University of Lyon | Recruiting | 6 Years | N/A | Both | 12 | N/A | France |
| 54 | EUCTR2007-004277-26-AT (EUCTR) | 21/01/2010 | 21/04/2009 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Cayston Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 55 | EUCTR2009-016590-15-HU (EUCTR) | 29/12/2009 | 25/11/2009 | A clinical trial to assess the treatment with nebulised tobramycin in terms of safety and ability to kill Pseudomonas bacteria in the lungs of cystic fibrosis patients aged 3 months to 6 years included | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacyand Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P.aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. | Lung colonisation 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 10068292;Term: Pseudomonas colonization;System Organ Class: 100000004862 MedDRA version: 14.1;Classification code 10068297;Term: Pseudomonas colonisation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI 300 mg / 5 mL nebuliser solution Product Name: TOBI Product Code: TBM100 INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | France;Hungary;Greece;Canada;Poland;Russian Federation;Germany;Italy;Switzerland | |||
| 56 | EUCTR2006-006215-68-FR (EUCTR) | 21/09/2009 | 06/08/2009 | A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA | A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA | cystic fibrosis and P. aeruginosa chronic infection MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Bramitob Product Name: Tobrineb/Bramitob INN or Proposed INN: tobramycin Trade Name: Tobi 300mg/5ml Nebuliser solution. Product Name: Tobi INN or Proposed INN: tobramycin | Chiesi Farmaceutici S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 3 | France;Hungary;Czech Republic;Spain;Germany | ||
| 57 | EUCTR2009-013660-39-FR (EUCTR) | 10/09/2009 | 27/11/2009 | Etude pharmacocinétique de l’équivalence de la biodisponibilité entre Nebcinal® 150mg/3ml administré par Aeroneb® Idehaler® et Tobi® 300mg/5ml administré par Pari LC Plus ® | Etude pharmacocinétique de l’équivalence de la biodisponibilité entre Nebcinal® 150mg/3ml administré par Aeroneb® Idehaler® et Tobi® 300mg/5ml administré par Pari LC Plus ® | Mucoviscidose MedDRA version: 12.0;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Nebcinal INN or Proposed INN: tobramycine Trade Name: Tobi Product Name: Tobi INN or Proposed INN: tobramycine | Erempharma SAS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 58 | NCT01111383 (ClinicalTrials.gov) | September 2009 | 13/4/2010 | A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI® | A Single Arm 48-Week Follow-on Safety Study to the Core Study (A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa) | Cystic Fibrosis | Drug: tobramycin | Chiesi Farmaceutici S.p.A. | NULL | Completed | 6 Years | N/A | All | 209 | Phase 3 | France;Poland;Ukraine |
| 59 | NCT00885365 (ClinicalTrials.gov) | April 2009 | 20/4/2009 | A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI® | A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: tobramycin / Bramitob;Drug: tobramycin / TOBI | Chiesi Farmaceutici S.p.A. | NULL | Completed | 6 Years | N/A | All | 324 | Phase 3 | Czechia;France;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine;Czech Republic |
| 60 | EUCTR2007-004277-26-GB (EUCTR) | 12/03/2009 | 08/02/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Cayston Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 61 | EUCTR2007-004277-26-PT (EUCTR) | 12/12/2008 | 17/10/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 62 | EUCTR2007-004277-26-DE (EUCTR) | 14/10/2008 | 29/05/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Cayston Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 63 | EUCTR2007-004277-26-ES (EUCTR) | 25/08/2008 | 24/01/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. Pacientes adultos y pediátricos con fibrosis quística (FQ) con infección pulmonar por Pseudomonas aeruginosa (PA). MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;France;Belgium;Spain;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 64 | EUCTR2006-006215-68-ES (EUCTR) | 22/08/2008 | 27/06/2008 | ENSAYO CLÍNICO MULTICÉNTRICO, MULTINACIONAL, ABIERTO, ALEATORIZADO, CON GRUPOS PARALELOS DE TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMICINA SOLUCIÓN PARA NEBULIZACIÓN, 300 mg DOS VECES AL DÍA EN VIALES UNIDOSIS DE 4 ML) EN COMPARACIÓN CON TOBI® EN EL TRATAMIENTO DE PACIENTES CON FIBROSIS QUÍSTICA E INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA | ENSAYO CLÍNICO MULTICÉNTRICO, MULTINACIONAL, ABIERTO, ALEATORIZADO, CON GRUPOS PARALELOS DE TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMICINA SOLUCIÓN PARA NEBULIZACIÓN, 300 mg DOS VECES AL DÍA EN VIALES UNIDOSIS DE 4 ML) EN COMPARACIÓN CON TOBI® EN EL TRATAMIENTO DE PACIENTES CON FIBROSIS QUÍSTICA E INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA | Infección pulmonar crónica por P. aeruginosa en pacientes con fibrosis quística MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Bramitob Product Name: Tobrineb/Bramitob INN or Proposed INN: tobramicina Trade Name: Tobi 300mg/5ml Solución para inhalación por nebulizador. Product Name: Tobi INN or Proposed INN: tobramycin | Chiesi Farmaceutici S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 3 | France;Hungary;Czech Republic;Spain;Germany | ||
| 65 | EUCTR2007-004507-36-DE (EUCTR) | 19/08/2008 | 19/10/2007 | A multicenter, open label, 2 period cross-over study to evaluate the Pharmacokinetics of an 8 week continuous treatment with 1x300mg/d and 2x300mg/d TOBI® inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) Subjects. | A multicenter, open label, 2 period cross-over study to evaluate the Pharmacokinetics of an 8 week continuous treatment with 1x300mg/d and 2x300mg/d TOBI® inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) Subjects. | patients with cystic fibrosis and chronical infection with Pseudomonas aeruginosa MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Tobi Product Name: Tobi Product Code: TBM100 INN or Proposed INN: Tobramycin Trade Name: Tobi Product Name: Tobi Product Code: TBM100 INN or Proposed INN: Tobramycin Trade Name: Tobi Product Name: Tobi Product Code: TBM100 INN or Proposed INN: Tobramycin Trade Name: Tobi Product Name: Tobi Product Code: TBM100 INN or Proposed INN: Tobramycin | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 66 | EUCTR2006-006215-68-DE (EUCTR) | 14/08/2008 | 18/12/2008 | A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA | A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA | cystic fibrosis and P. aeruginosa chronic infection MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Bramitob Product Name: Tobrineb/Bramitob INN or Proposed INN: tobramycin Trade Name: Tobi 300mg/5ml Nebuliser solution. Product Name: Tobi INN or Proposed INN: tobramycin | Chiesi Farmaceutici S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 320 | France;Hungary;Czech Republic;Spain;Germany | |||
| 67 | EUCTR2006-006215-68-HU (EUCTR) | 13/08/2008 | 25/06/2008 | A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA | A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA | cystic fibrosis and P. aeruginosa chronic infection MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Bramitob Product Name: Tobrineb/Bramitob INN or Proposed INN: tobramycin Trade Name: Tobi 300mg/5ml Nebuliser solution. Product Name: Tobi INN or Proposed INN: tobramycin | Chiesi Farmaceutici S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Germany;Czech Republic;France;Spain | |||
| 68 | EUCTR2006-006215-68-CZ (EUCTR) | 29/07/2008 | 16/06/2008 | A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA | A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA | cystic fibrosis and P. aeruginosa chronic infection MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Bramitob Product Name: Tobrineb/Bramitob INN or Proposed INN: tobramycin Trade Name: Tobi 300mg/5ml Nebuliser solution. Product Name: Tobi INN or Proposed INN: tobramycin | Chiesi Farmaceutici S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 3 | France;Hungary;Czech Republic;Spain;Germany | ||
| 69 | EUCTR2007-004277-26-IE (EUCTR) | 19/06/2008 | 27/02/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 70 | EUCTR2007-004277-26-NL (EUCTR) | 10/06/2008 | 29/05/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open-Label, Single Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open-Label, Single Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 71 | 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 | ||
| 72 | EUCTR2007-004277-26-FR (EUCTR) | 30/04/2008 | 21/01/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 73 | EUCTR2007-004277-26-BE (EUCTR) | 29/04/2008 | 20/12/2007 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 74 | EUCTR2007-004277-26-IT (EUCTR) | 23/04/2008 | 17/06/2008 | An open-label, randomised, phase 3 trial to evaluate the efficacy and safety of Aztreonan LYsine for inhalation versus Tobramycin nebuliser solution in an intermittent aerosolized antibiotic regimen in patients with cystic fibrosis. - ND | An open-label, randomised, phase 3 trial to evaluate the efficacy and safety of Aztreonan LYsine for inhalation versus Tobramycin nebuliser solution in an intermittent aerosolized antibiotic regimen in patients with cystic fibrosis. - ND | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: aztreonan lysine Product Code: AZLI INN or Proposed INN: Aztreonam Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML INN or Proposed INN: Tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 75 | EUCTR2008-006502-42-IT (EUCTR) | 22/04/2008 | 07/04/2010 | Early antibiotic treatment in pseudomonas aeruginosa eradication in cystic fibrosis patients: a randomised policentric study on two different protocols - #FFC17/2007 | Early antibiotic treatment in pseudomonas aeruginosa eradication in cystic fibrosis patients: a randomised policentric study on two different protocols - #FFC17/2007 | Cystic fibrosis MedDRA version: 9.1;Level: SOC;Classification code 10038738 | Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML INN or Proposed INN: Tobramycin INN or Proposed INN: Colistin INN or Proposed INN: Ciprofloxacin | AZIENDA OSPEDALIERA MEYER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 76 | EUCTR2007-004277-26-DK (EUCTR) | 16/04/2008 | 12/03/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 77 | EUCTR2007-005346-20-GB (EUCTR) | 04/12/2007 | 28/11/2007 | Does nebulised tobramycin (TOBI) via e-flow delivery systems cause a raised peak serum tobramycin level in children with Cystic Fibrosis? - TOBICF | Does nebulised tobramycin (TOBI) via e-flow delivery systems cause a raised peak serum tobramycin level in children with Cystic Fibrosis? - TOBICF | Children with cystic fibrosis | Trade Name: Tobi 300 mg/5 ml Nebuliser Solution Product Name: TOBI INN or Proposed INN: tobramycin | Leeds Teaching Hospitals NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 30 | United Kingdom | |||
| 78 | 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 | ||
| 79 | EUCTR2007-000959-33-DE (EUCTR) | 16/08/2007 | 04/04/2007 | Randomized, open labelled, cross over deposition study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS® in subjects with CF | Randomized, open labelled, cross over deposition study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS® in subjects with CF | Cystic Fibrosis with Pseudomonas aeruginosa infection | Product Name: Tobramycin 100 PARI Product Code: T100 PARI INN or Proposed INN: Tobramycin Trade Name: TOBI® INN or Proposed INN: Tobramycin | PARI GmbH | NULL | Not Recruiting | Female: yes Male: yes | 25 | Germany | |||
| 80 | EUCTR2005-004103-10-DE (EUCTR) | 03/05/2006 | 30/01/2006 | Randomized, open labeled, multi center, active controlled, parallel 28 days safety and bioavailability study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS in cystic fibrosis patients with Pseudomonas Aeruginosa infections | Randomized, open labeled, multi center, active controlled, parallel 28 days safety and bioavailability study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS in cystic fibrosis patients with Pseudomonas Aeruginosa infections | Cystic Fibrosis with Pseudomoas aeuriginosa infection MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Tobramycin 100 PARI Product Code: T100 PARI INN or Proposed INN: Tobramycin Trade Name: Tobi Product Name: TOBI® INN or Proposed INN: Tobramycin | PARI Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Germany | |||
| 81 | 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 | ||
| 82 | 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 | ||
| 83 | 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 | ||
| 84 | EUCTR2004-003675-36-BE (EUCTR) | 27/10/2005 | 13/10/2005 | A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection | A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection | Pseudomonas aeruginosa (PA) infection in patients with cystic fibrosis. | Product Name: Colobreathe INN or Proposed INN: Colistimethate sodium Other descriptive name: Colomycin Trade Name: TOBI 300 mg/5 ml Nebuliser Solution Product Name: TOBI® INN or Proposed INN: Tobramycin Other descriptive name: TOBI® | Forest Laboratories UK Ltd | NULL | Not Recruiting | Female: yes Male: yes | 360 | Denmark;Belgium | |||
| 85 | EUCTR2004-003675-36-DK (EUCTR) | 28/04/2005 | 06/12/2004 | A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection | A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection | Pseudomonas aeruginosa (PA) infection in patients with cystic fibrosis. | Product Name: Colobreathe INN or Proposed INN: Colistimethate sodium Other descriptive name: Colomycin Product Name: TOBI® INN or Proposed INN: Tobramycin Other descriptive name: TOBI® | Forest Laboratories UK Ltd | NULL | Not Recruiting | Female: yes Male: yes | 360 | Belgium;Denmark | |||
| 86 | EUCTR2004-003675-36-AT (EUCTR) | 19/04/2005 | 15/03/2005 | A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection | A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection | Pseudomonas aeruginosa (PA) infection in patients with cystic fibrosis. | Product Name: Colobreathe INN or Proposed INN: Colistimethate sodium Other descriptive name: Colomycin Trade Name: TOBI 300 mg/5 ml Nebuliser Solution Product Name: TOBI® INN or Proposed INN: Tobramycin Other descriptive name: TOBI® | Forest Laboratories UK Ltd | NULL | Not Recruiting | Female: yes Male: yes | 360 | Belgium;Denmark;Austria | |||
| 87 | NCT00097773 (ClinicalTrials.gov) | September 2004 | 30/11/2004 | Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis | Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas Aeruginosa Airway Infection in Young Patients With Cystic Fibrosis | Cystic Fibrosis;Pulmonary Disease, Chronic Obstructive | Drug: Tobramycin solution for inhalation (TOBI);Drug: Oral placebo;Drug: Oral ciprofloxacin | Seattle Children's Hospital | National Heart, Lung, and Blood Institute (NHLBI);Cystic Fibrosis Foundation Therapeutics;CF Therapeutics Development Network Coordinating Center | Completed | 1 Year | 12 Years | All | 304 | Phase 2 | United States |
| 88 | NCT01400750 (ClinicalTrials.gov) | August 2001 | 18/7/2011 | Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis | Prospective Randomized Trial Comparing Oral Ciproxin Plus Inhaled Colistin With Tobramycin for Inhalation for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis. | Cystic Fibrosis | Drug: oral ciprofloxacin plus inhaled colistin;Drug: TOBI | Universitaire Ziekenhuizen Leuven | NULL | Completed | N/A | 18 Years | Both | 61 | Phase 4 | Belgium |
| 89 | EUCTR2005-004103-10-PL (EUCTR) | 26/09/2007 | Randomized, open labeled, multi center, active controlled, parallel 28 days safety and bioavailability study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS® in cystic fibrosis patients with Pseudomonas Aeruginosa infections | Randomized, open labeled, multi center, active controlled, parallel 28 days safety and bioavailability study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS® in cystic fibrosis patients with Pseudomonas Aeruginosa infections | Cystic Fibrosis with Pseudomonas aeruginosa infections MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Tobramycin 100 PARI Product Code: T 100 PARI Other descriptive name: tobramycinum Trade Name: TOBI Other descriptive name: tobramycinum | PARI GmbH | NULL | NA | Female: yes Male: yes | 60 | Phase 1 | Poland;Germany | |||
| 90 | 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 | |||
| 91 | 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 | |||
| 92 | EUCTR2007-004277-26-Outside-EU/EEA (EUCTR) | 02/02/2015 | A Clinical Trial to Evaluate the Efficacy and Safety of the drug Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) in comparison to the drug Tobramycin Nebulizer Solution (TNS) in patients with Cystic Fibrosis. | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension. | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston INN or Proposed INN: AZTREONAM Trade Name: TOBI INN or Proposed INN: TOBRAMYCIN Other descriptive name: TOBRAMYCIN | Gilead Sciences Inc | NULL | NA | Female: yes Male: yes | 268 | Phase 3 | United States | |||
| 93 | EUCTR2010-019634-26-FR (EUCTR) | 08/02/2011 | A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy ofMP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis Patients | A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy ofMP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis Patients | Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: Aeroquin Product Code: MP-376 INN or Proposed INN: levofloxacin Other descriptive name: levofloxacin hemihydrate Trade Name: TOBI 300 mg/5 ml, solution pour inhalation par nébuliseur INN or Proposed INN: TOBRAMYCIN | Mpex Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 330 | Phase 3 | France;Ireland;Germany;United Kingdom | |||
| 94 | EUCTR2010-023533-34-FR (EUCTR) | 14/12/2010 | Etude pharmacocinétique de l’équivalence de la biodisponibilité entre Nebcinal® 150mg/3ml administré par Aeroneb® Idehaler® et Tobi® 300mg/5ml administré par Pari LC Plus ® /Pulmoaid ® chez des patients atteints de mucoviscidose. | Etude pharmacocinétique de l’équivalence de la biodisponibilité entre Nebcinal® 150mg/3ml administré par Aeroneb® Idehaler® et Tobi® 300mg/5ml administré par Pari LC Plus ® /Pulmoaid ® chez des patients atteints de mucoviscidose. | Mucoviscidose MedDRA version: 12.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Nebcinal Product Code: Nebcinal Trade Name: Tobi Product Name: Tobi | EREMPHARMA SAS | NULL | NA | Female: yes Male: yes | Phase 1 | France | ||||
| 95 | EUCTR2014-003882-10-FR (EUCTR) | 29/07/2015 | Evaluation of the efficacy of antibiotic treatments associated with the Nebcine® as intravenous injection only and / or monitoring of aerosols of Tobi® in order to optimize the therapeutic management of exacerbations in patients with cystic fibrosis . | Evaluation of the effectiveness of a treatment involving one (or several ) antibiotic (s) with 14-day tobramycin ( Nebcine® ) by intravenous injection versus the same antibiotic treatment (s ) associated with only 5 days of tobramycin ( Nebcine® ) by intravenous injection followed tobramycin aerosol ( Tobi® ) for 9 days in the context of cystic fibrosis | mucoviscidosis or cystic fibrosis MedDRA version: 18.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: NEBCINE Product Name: NEBCINE Other descriptive name: TOBRAMYCIN Trade Name: NEBCINE Product Name: NEBCINE Other descriptive name: TOBRAMYCIN Trade Name: NEBCINE Product Name: NEBCINE Other descriptive name: TOBRAMYCIN Trade Name: NEBCINE Product Name: NEBCINE Other descriptive name: TOBRAMYCIN Trade Name: TOBI Product Name: TOBI Other descriptive name: TOBRAMYCIN | CHRU de Lille | NULL | NA | Female: yes Male: yes | Phase 2 | France | ||||
| 96 | EUCTR2010-023235-41-PL (EUCTR) | 28/01/2011 | A comparative, randomised, two period, multi-center, cross-over 14 weeksbioequivalence study of Tobramycin PARI (T100) versus TOBI® (Novartis) incystic fibrosis patients with bronchopulmonary chronic Pseudomonasaeruginosa infection - T-100 BE | A comparative, randomised, two period, multi-center, cross-over 14 weeksbioequivalence study of Tobramycin PARI (T100) versus TOBI® (Novartis) incystic fibrosis patients with bronchopulmonary chronic Pseudomonasaeruginosa infection - T-100 BE | Cystic fibrosis with bronchopulmonary chronic Pseudomonas aeruginosa infection MedDRA version: 12.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Tobramycin Product Code: T100 INN or Proposed INN: Tobramycin Other descriptive name: Tobramycinum Trade Name: TOBI® INN or Proposed INN: TOBRAMYCIN | PARI Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 1 | Poland | |||
| 97 | 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 | |||
| 98 | EUCTR2015-000398-11-Outside-EU/EEA (EUCTR) | 03/02/2015 | A Clinical Trial to Assess the Safety and Efficacy of an Alternating Therapy of Antibiotics with the Drug Aztreonam for Inhalation Solution (AZLI) for the Treatment of Lung Infection by the bacteria Pseudomonas aeruginosa in Patients with Cystic Fibrosis. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas aeruginosa Infection in Subjects with Cystic Fibrosis | Cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston INN or Proposed INN: AZTREONAM Trade Name: TOBI® INN or Proposed INN: TOBRAMYCIN Other descriptive name: TOBRAMYCIN | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 250 | Phase 3 | United States | |||
| 99 | 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 |