Colistin Systemic Exposure (COSY) study

• Research type

  Research Study

• Full title

  A 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.

• IRAS ID

  73472

• Contact name

  James Greenwood

• Sponsor organisation

  Forest Laboratories UK Ltd.

• Eudract number

  2011-000192-13

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of this study is to investigate how much colistimethate (Colobreathe©) is absorbed systemically into the body (i.e. can be found in the blood and urine) when multiple doses over the period of one week have been taken as a dry powder inhaled into the lungs. The target population for the drug are Cystic Fibrosis patients, with chronic pulmonary (lung) infection (with Pseudomonas aeruginosa [PA]).N.B. The study protocol also covers the study being done in children and adolescents, but ONLY THE ADULT ARM of the study is being conducted in the UK, as children very rarely suffer from chronic PA infection in the UK.

• REC name

  HSC REC B

• REC reference

  11/NI/0031

• Date of REC Opinion

  28 Apr 2011

• REC opinion

  Further Information Favourable Opinion