Safety, efficacy and convenience of colistimethate sodium dry powder for inhalation (Colobreathe DPI) in patients with cystic fibrosis: a randomised study.

ABSTRACT:

Purpose

To assess efficacy and safety of a new dry powder formulation of inhaled colistimethate sodium in patients with cystic fibrosis (CF) aged ≥6 years with chronic Pseudomonas aeruginosa lung infection.

Study design and methods

A prospective, centrally randomised, phase III, open-label study in patients with stable CF aged ≥6 years with chronic P aeruginosa lung infection. Patients were randomised to Colobreathe dry powder for inhalation (CDPI, one capsule containing colistimethate sodium 1 662 500 IU, twice daily) or three 28-day cycles with twice-daily 300 mg/5 ml tobramycin inhaler solution (TIS). Study duration was 24 weeks.

Results

380 patients were randomised. After logarithmic transformation of data due to a non-normal distribution, adjusted mean difference

SUBMITTER: Schuster A 

PROVIDER: S-EPMC3595146 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature