At a glance
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Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects
In Brief
A Phase 3 clinical trial evaluating Inhaled mannitol and Placebo Comparator: Arm B - Control for Cystic Fibrosis. Completed, enrolled 423 participants across 100 sites in 18 countries.
Detailed Summary
This trial aims to provide prospective evidence of the safety and efficacy of mannitol 400 mg b.i.d. in subjects aged 18 years and above. We hypothesize that inhaled mannitol 400 mg b.i.d. will increase the mean change from baseline FEV1 (mL) compared to control over the 26-week treatment period in adult subjects with cystic fibrosis. Any improvement in FEV1 is considered clinically meaningful, however, this trial has set a threshold of 80 mL for the purposes of determining an appropriate sample size for statistical power while retaining trial feasibility in an orphan disease population
Study Details
Timeline
Interventions
Inhaled mannitol 400 mg BD for 26 weeks
Placebo Comparator: Arm B - Control BD for 26 weeks