NCT00277537

Safety and Efficacy of Bronchitol in Bronchiectasis

A Phase III Multicenter, Randomised, Parallel, Placebo-Controlled, Double-Blind Study to Investigate the Safety and Efficacy of Treatment With Bronchitol (Dry Powder Mannitol) in the Symptomatic Treatment of Bronchiectasis.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 354 (estimated)
• Sponsor: Syntara · Industry
• Sex: All
• Age: 15 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
DRUG	Mannitol	320mg BD 12 weeks followed by 40 weeks open label
DRUG	placebo	BD for 12 weeks

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2006-01-16
• Last updated: 2008-08-29

Locations

22 sites across 3 countries: Australia, New Zealand, United Kingdom