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 adverse events 12 weeks / 12 months haematology, biochemistry, 12 weeks / 12 months sputum microbiology quantitative and qualitative 12 weeks / 12 months
Trial Locations
- Locations (22)
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Belfast City Hospital
🇬🇧Belfast, Northern Ireland, United Kingdom
St George Hospital
🇦🇺Kogarah, New South Wales, Australia
Royal Prince Alfred Hospital
🇦🇺Camperdown Sydney, New South Wales, Australia
Cairns Base Hospital
🇦🇺Cairns, Queensland, Australia
Greenlane Hospital
🇳🇿Auckland, New Zealand
Burnside War Memorial Hospital
🇦🇺Toorak Gardens, Adelaide, South Australia, Australia
Repatriation General Hospital
🇦🇺Adelaide, South Australia, Australia
Norfolk and Norwich University Hospital
🇬🇧Norwich, United Kingdom
Middlemore Hospital
🇳🇿Auckland, New Zealand
AARI Sir Charles Gairdner Hospital
🇦🇺Perth, Western Australia, Australia
Peninsula Health Frankston Hospital
🇦🇺Frankston, Victoria, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Papworth Hospital
🇬🇧Cambridge, United Kingdom
Canberra Hospital
🇦🇺Canberra, Australian Capital Territory, Australia
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
Mater Adult Hospital
🇦🇺Brisbane, Queensland, Australia
Bankstown Hospital
🇦🇺Sydney, New South Wales, Australia
John Hunter Hospital
🇦🇺Newcastle, New South Wales, Australia
Glenfield Hospital
🇬🇧Leicester, United Kingdom
North West Lung Centre, Wythshawe Hospital
🇬🇧Manchester, United Kingdom