TOBI*NEBUL 56F 1D 300MG/5ML ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
299嚢胞性線維症3

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-016590-15-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
2EUCTR2007-004277-26-IT
(EUCTR)
23/04/200817/06/2008An 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. - NDAn 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 IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
3EUCTR2008-006502-42-IT
(EUCTR)
22/04/200807/04/2010Early antibiotic treatment in pseudomonas aeruginosa eradication in cystic fibrosis patients: a randomised policentric study on two different protocols - #FFC17/2007Early 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 MEYERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy