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A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects

Inhaled mannitol · ANZCTR · Phase 3

Registry ID
NCT02134353
Phase
Phase 3
Status
Completed
Drug / intervention
Inhaled mannitol
Mechanism
ANZCTR
Sponsor
Syntara
Start
2014-09
Enrollment
423
Locations
100

About this trial

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

View NCT02134353 on ClinicalTrials.gov →

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Medical disclaimer. This page summarizes public trial data for NCT02134353 for information only. It is not medical advice, an endorsement, or an offer to enroll. Confirm details on ClinicalTrials.gov and with a qualified physician.