A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects
Status:
Completed
Trial end date:
2017-02-01
Target enrollment:
Participant gender:
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