Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study
Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine the efficacy and safety of chronic treatment with
inhaled dry powder mannitol in subjects with cystic fibrosis. Previous studies have
demonstrated an improvement in lung function related to small airways obstruction and a
significant improvement in respiratory symptoms and quality of life after a 2 week treatment
with mannitol. This current study seeks to support these early findings and to extend the
evidence to support its use as a mucoactive therapy in cystic fibrosis. In particular, the
hypothesis that enhanced mucus clearance will improve the lung function and clinical
presentation in this population, will be investigated. We also hypothesize that enhanced
mucociliary clearance will result in a sustained reduction in mucus load, thus providing less
opportunity for bacteria to proliferate, affording a reduction in antibiotic use and
hospitalizations. The initial 6 month blinded phase will be followed with an additional 6
months of open label treatment.