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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mannitol | Drug | 320mg BD 12 weeks followed by 40 weeks open label |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 24 hour sputum clearance | 24 hours / 12 weeks | |
| Quality of Life SGRQ | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| bronchiectasis symptoms | 12 weeks | |
| cough severity | 12 weeks | |
| exercise capacity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brett Charlton | Pharmaxis Ltd Australia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canberra Hospital | Canberra | Australian Capital Territory | Australia | |||
| Royal Prince Alfred Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23429964 | Derived | 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. |
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| placebo |
| Drug |
BD for 12 weeks |
|
| 12 weeks |
| lung function, including gas transfer | 12 weeks |
| antibiotic use | 12 weeks |
| bronchial wall thickening and inflammation | 12 weeks |
| adverse events | 12 weeks / 12 months |
| haematology, biochemistry, | 12 weeks / 12 months |
| sputum microbiology quantitative and qualitative | 12 weeks / 12 months |
| 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 |
| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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