299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174

  
4 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2010-019634-26-GB
(EUCTR)
18/08/201107/02/2011Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) PatientsA 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.NULLNot 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): noFrance;United States;Canada;Ireland;Israel;Germany;United Kingdom
2EUCTR2007-005346-20-GB
(EUCTR)
04/12/200728/11/2007Does nebulised tobramycin (TOBI) via e-flow delivery systems cause a raised peak serum tobramycin level in children with Cystic Fibrosis? - TOBICFDoes nebulised tobramycin (TOBI) via e-flow delivery systems cause a raised peak serum tobramycin level in children with Cystic Fibrosis? - TOBICF Children with cystic fibrosisTrade Name: Tobi 300 mg/5 ml Nebuliser Solution
Product Name: TOBI
INN or Proposed INN: tobramycin
Leeds Teaching Hospitals NHS TrustNULLNot RecruitingFemale: yes
Male: yes
30United Kingdom
3EUCTR2004-003675-36-BE
(EUCTR)
27/10/200513/10/2005A 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 infectionA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
360Denmark;Belgium
4EUCTR2004-003675-36-AT
(EUCTR)
19/04/200515/03/2005A 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 infectionA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
360Belgium;Denmark;Austria