TOBI 300 mg/5 ml solución para inhalación por nebulizador ( 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1

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
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
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PhaseCountries
1EUCTR2012-001565-33-ES
(EUCTR)
04/07/201316/05/2013An 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 colistinAn 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.NULLNot RecruitingFemale: yes
Male: yes
67Phase 4Spain;Ireland;Germany;United Kingdom;Switzerland