Safety and Efficacy of Bronchitol in Bronchiectasis

Phase 3 Completed 354 enrolled Syntara

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Study will assess the safety and effectiveness of 12 week treatment with the study medication, Bronchitol, in subjects with bronchiectasis (a lung disease where patients have trapped, and often infected, thick, sticky mucus). Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology (making it less thick and sticky), thereby enhancing the shift of stagnant mucus from the lungs. On completion of the double blind phase, subjects will have the opportunity to participate in a 52 week open label phase.

Timeline

Start: 2006-03
Primary completion: 2008-07
Completion: 2008-07

Outcome

Mixed primary results

paper There was a significant difference of 4.3 g in terms of change in sputum weight over 12 weeks (95% CI, 1.64-7.00; P=.002) between mannitol and placebo; PMID 23429964 ↗

paper this was largely driven by a decrease in sputum weight in the placebo group. PMID 23429964 ↗

paper There was no statistical difference between the groups (P=.304) in total SGRQ score PMID 23429964 ↗

Publications

Bilton D, Daviskas E, Anderson SD, Kolbe J, King G, Stirling RG, Thompson BR, Milne D, Charlton B; B301 Investigators. Phase 3 randomized study of the efficacy and safety of inhaled dry powder mannitol for the symptomatic treatment of non-cystic fibrosis bronchiectasis. Chest. 2013 Jul;144(1):215-225. doi: 10.1378/chest.12-1763.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mannitol	Diagnostic / imaging agent	320 mg	Inhaled