Brief Title
Safety and Efficacy of Bronchitol in Bronchiectasis
Official Title
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.
Brief 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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
24 hour sputum clearance
Secondary Outcome
bronchiectasis symptoms
Condition
Bronchiectasis
Intervention
Mannitol
Study Arms / Comparison Groups
1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
354
Start Date
March 2006
Completion Date
July 2008
Primary Completion Date
July 2008
Eligibility Criteria
Inclusion Criteria:
- Non cystic fibrosis bronchiectasis
- Have FEV1 50% - 80% predicted and ≥1.0L
- Have chronic sputum production of >10 mL per day on the majority of days in the 3
months prior to study entry
Exclusion Criteria:
- Be using hypertonic saline or mucolytic pharmacological agents concurrently or in the
4 weeks prior to study entry
- Have airway hyperresponsiveness as defined by a positive Aridol challenge
Gender
All
Ages
15 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Brett Charlton, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00277537
Organization ID
DPM-B-301
Study Sponsor
Pharmaxis
Study Sponsor
Brett Charlton, Study Director, Pharmaxis Ltd Australia
Verification Date
August 2008