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.

Trial Profile

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.

Completed
Phase of Trial: Phase I

Latest Information Update: 22 Mar 2014

At a glance

  • Drugs Colistimethate sodium (Primary)
  • Indications Pseudomonal infections
  • Focus Pharmacokinetics
  • Acronyms COSY
  • Sponsors Forest Laboratories
  • Most Recent Events

    • 02 Jun 2012 Planned number of patients changed from 28 to 40 and additional locations (Germany, Poland) added as reported by European Clinical Trials Database record.
    • 02 Jun 2012 Planned end date changed from 17 Sep 2011 to 28 Oct 2011 as reported by European Clinical Trials Database record.
    • 02 Jun 2012 Actual initiation date changed from 17 Mar 2011 to 28 Apr 2011 as reported by European Clinical Trials Database record.
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