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

  
6 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2011-000192-13-PL
(EUCTR)
08/07/201131/05/2011A study to investigate the drug levels of colistimethate sodium after inhalation of Colobreathe® in subjects with cystic fibrosisA 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study systemic exposure of colobreathe in cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa
MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 13.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Colobreathe
Product Code: N/A
INN or Proposed INN: Colistimethate sodium
Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate
Forest Laboratories UK Ltd.NULLNot RecruitingFemale: yes
Male: yes
28Poland;Ukraine;Germany;United Kingdom
2EUCTR2011-000192-13-DE
(EUCTR)
05/05/201105/04/2011A study to investigate the drug levels of colistimethate sodium after inhalation of Colobreathe® in subjects with cystic fibrosisA 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study systemic exposure of colobreathe in cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa
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;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Colobreathe
Product Code: N/A
INN or Proposed INN: Colistimethate sodium
Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate
Forest Laboratories UK Ltd.NULLNot RecruitingFemale: yes
Male: yes
40Poland;Ukraine;Germany;United Kingdom
3EUCTR2011-000192-13-GB
(EUCTR)
28/04/201117/03/2011A 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) studyA 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa
MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 13.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Name: Colobreathe
Product Code: N/A
INN or Proposed INN: Colistimethate sodium
Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate
Forest Laboratories UK Ltd.NULLNot RecruitingFemale: yes
Male: yes
28Germany;United Kingdom;Poland
4EUCTR2004-003675-36-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
5EUCTR2004-003675-36-DK
(EUCTR)
28/04/200506/12/2004A 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
Product Name: TOBI®
INN or Proposed INN: Tobramycin
Other descriptive name: TOBI®
Forest Laboratories UK LtdNULLNot RecruitingFemale: yes
Male: yes
360Belgium;Denmark
6EUCTR2004-003675-36-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