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

  
12 trials found
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PhaseCountries
1NCT02677701
(ClinicalTrials.gov)
October 21, 201629/1/2016Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic Fibrosis (CF)TEACH Trial: Testing the Effect of Adding CHronic Azithromycin to Inhaled Tobramycin. A Randomized, Placebo-controlled, Double-blinded Trial of Azithromycin 500mg Thrice Weekly in Combination With Inhaled TobramycinCystic FibrosisDrug: azithromycin;Drug: placebo (for azithromycin);Drug: inhaled tobramycinSeattle Children's HospitalNational Heart, Lung, and Blood Institute (NHLBI);Cystic Fibrosis Foundation;CF Therapeutics Development Network Coordinating CenterCompleted12 YearsN/AAll119Phase 4United States
2EUCTR2009-016590-15-PL
(EUCTR)
03/12/201311/10/2013A 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 includedA 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 AGNULLNot RecruitingFemale: yes
Male: yes
50United States;Greece;Russian Federation;Switzerland;Italy;France;Egypt;Hungary;Canada;Argentina;Poland;Romania;Germany
3EUCTR2009-016590-15-IT
(EUCTR)
01/07/201114/03/2012Evaluation 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 FARMANULLNot RecruitingFemale: yes
Male: yes
72France;Hungary;Greece;Canada;Poland;Russian Federation;Germany;Switzerland;Italy
4EUCTR2009-016590-15-DE
(EUCTR)
19/07/201015/04/2010A 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 includedA 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 AGNULLNot RecruitingFemale: yes
Male: yes
50France;Egypt;Hungary;Greece;Canada;Argentina;Poland;Romania;Russian Federation;Germany;Switzerland;Italy
5EUCTR2009-016590-15-GR
(EUCTR)
15/06/201031/12/2009A 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 AGNULLNot RecruitingFemale: yes
Male: yes
72France;Hungary;Greece;Poland;Germany;Italy
6EUCTR2009-016590-15-FR
(EUCTR)
15/04/201014/12/2009A 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 AGNULLNot RecruitingFemale: yes
Male: yes
72Phase 3France;Hungary;Greece;Poland;Germany;Italy
7NCT01082367
(ClinicalTrials.gov)
April 20105/3/2010Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 YearsA 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 YearsTreatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis PatientsDrug: TOBI;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted3 Months6 YearsAll50Phase 3Canada;Egypt;France;Germany;Greece;Hungary;Italy;Romania;Russian Federation;Switzerland;Poland;United States
8EUCTR2009-016590-15-HU
(EUCTR)
29/12/200925/11/2009A 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 includedA 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 AGNULLNot RecruitingFemale: yes
Male: yes
50France;Hungary;Greece;Canada;Poland;Russian Federation;Germany;Italy;Switzerland
9EUCTR2007-003868-22-FR
(EUCTR)
19/03/200820/12/2007ASSESMENT OG EFFICACY AND TOLERABILITY OF INHABLED TOBRAMYCIN VS PLACEBO IN CYSTIC FIBROSIS PATIENTS REVEIVING ANTIBIOTHERAPY FOR 28 DAYS FOR PSEUDOMONAS AERUGINOSA PRIMO COLONISATION. - NEBCINAL 01-07ASSESMENT OG EFFICACY AND TOLERABILITY OF INHABLED TOBRAMYCIN VS PLACEBO IN CYSTIC FIBROSIS PATIENTS REVEIVING ANTIBIOTHERAPY FOR 28 DAYS FOR PSEUDOMONAS AERUGINOSA PRIMO COLONISATION. - NEBCINAL 01-07 Assessment of microbiological efficacy and tolerability of inhaled tobramycin vs placebo in cystic fibrosis patients, primo colonised by Pseudomonas aeruginosa justified inhaled antiobiotherapeutical treatment during 28 days. Product Code: NEB/01-07Laboratoire ErempharmaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
10NCT00634192
(ClinicalTrials.gov)
February 20084/3/2008Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled TobramycinA Multicenter, Open Label, 2 Period Cross-over Study to Evaluate the PK of a 8 Week Continuous Treatment With 1x300mg/d and 2x300mg/d Tobramycin Inhaled With a 'Soft Mist' Nebulizer in Cystic Fibrosis (CF) SubjectsPseudomonas InfectionsDrug: tobramycinNovartisNULLCompleted6 YearsN/AAll50Phase 3Germany
11NCT00823238
(ClinicalTrials.gov)
July 200429/12/2008Comparison of Antibiotics for Pseudomonas in Early CFComparison of Antibiotics for Pseudomonas in Early CFCystic FibrosisDrug: ceftazidime and tobramycin;Drug: inhaled tobramycinUniversity of North Carolina, Chapel HillCystic Fibrosis Foundation TherapeuticsCompleted3 Months16 YearsBoth21Phase 1United States
12NCT00391976
(ClinicalTrials.gov)
November 200319/10/2006Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic FibrosisThe Microbiologic Efficacy and Safety of Two Treatment Regimens of Inhaled Tobramycin Nebuliser Solution (TNS) for the Treatment of Early Onset Pseudomonas Aeruginosa Lower Respiratory Tract Infection in Subjects With Cystic FibrosisCystic FibrosisDrug: Tobramycin solution for inhalation 300 mgNovartisNULLCompleted6 MonthsN/AAll123Phase 3NULL