Long Term Administration of Inhaled Mannitol in Cystic Fibrosis
Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with
inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated
improvements in lung function, mucociliary clearance, changes in physical properties of
mucus, 24 hour sputum weight and quality of life. The results of this study are to further
investigate and confirm these findings in addition to examine the effect on antibiotic use
and chest infections. It is hypothesised that inhaled mannitol will have beneficial effects
compared to a control treatment. An open label phase of 26 weeks duration will follow the
blinded 26 week phase. During the open label phase all subjects will receive active
treatment.
Phase:
Phase 3
Details
Lead Sponsor:
Pharmaxis
Collaborators:
Argentina: Resolution Latin America; Buenos Aires, Argentina ethica Clinical Research Inc. Europe: KasaConsult bvba, Hoegaarden, Belgium