Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
354 participants
INTERVENTIONAL
2006-03-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Mannitol
320mg BD 12 weeks followed by 40 weeks open label
2
placebo
BD for 12 weeks
Interventions
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Mannitol
320mg BD 12 weeks followed by 40 weeks open label
placebo
BD for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* Have airway hyperresponsiveness as defined by a positive Aridol challenge
15 Years
80 Years
ALL
No
Sponsors
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Syntara
INDUSTRY
Responsible Party
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Pharmaxis Ltd
Principal Investigators
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Brett Charlton
Role: STUDY_DIRECTOR
Pharmaxis Ltd Australia
Locations
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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
Burnside War Memorial Hospital
Toorak Gardens, Adelaide, South Australia, Australia
Peninsula Health Frankston Hospital
Frankston, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
AARI Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Greenlane Hospital
Auckland, , New Zealand
Middlemore Hospital
Auckland, , New Zealand
Belfast City Hospital
Belfast, Northern Ireland, United Kingdom
Papworth Hospital
Cambridge, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
North West Lung Centre, Wythshawe Hospital
Manchester, , United Kingdom
Norfolk and Norwich University Hospital
Norwich, , United Kingdom
Countries
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References
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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.
Other Identifiers
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DPM-B-301
Identifier Type: -
Identifier Source: org_study_id