Safety and Efficacy of Bronchitol in Bronchiectasis
- Registration Number
- NCT00277537
- Lead Sponsor
- Syntara
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 354
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 placebo - 1 Mannitol -
- Primary Outcome Measures
Name Time Method 24 hour sputum clearance 24 hours / 12 weeks Quality of Life SGRQ 12 weeks
- Secondary Outcome Measures
Name Time Method cough severity 12 weeks bronchial wall thickening and inflammation 12 weeks bronchiectasis symptoms 12 weeks exercise capacity 12 weeks lung function, including gas transfer 12 weeks antibiotic use 12 weeks haematology, biochemistry, 12 weeks / 12 months sputum microbiology quantitative and qualitative 12 weeks / 12 months adverse events 12 weeks / 12 months
Trial Locations
- Locations (22)
Canberra Hospital
🇦🇺Canberra, Australian Capital Territory, Australia
Royal Prince Alfred Hospital
🇦🇺Camperdown Sydney, New South Wales, Australia
St George Hospital
🇦🇺Kogarah, New South Wales, Australia
John Hunter Hospital
🇦🇺Newcastle, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
Bankstown Hospital
🇦🇺Sydney, New South Wales, Australia
Mater Adult Hospital
🇦🇺Brisbane, Queensland, Australia
Cairns Base Hospital
🇦🇺Cairns, Queensland, Australia
Repatriation General Hospital
🇦🇺Adelaide, South Australia, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
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