Conditions: Cystic Fibrosis
Keywords: cystic fibrosis mannitol mucoactive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 318
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: active treatment arm 2: None

Interventions: intervention 1: inhaled mannitol intervention 2: Placebo comparator
Intervention descriptions: intervention 1: 400 mg BD for 26 + 26 weeks intervention 2: BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase

Protocol document: