Safety and Efficacy of Bronchitol in Bronchiectasis

Bronchiectasis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00277537
• Other study ID #: DPM-B-301
• Status: Completed
• Phase: Phase 3
• First received: January 13, 2006
• Last updated: August 27, 2008
• Start date: March 2006
• Est. completion date: July 2008

Study information

• Verified date: August 2008
• Source: Pharmaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyNew Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Drug:
• Mannitol
320mg BD 12 weeks followed by 40 weeks open label
• placebo
BD for 12 weeks

Locations

Country	Name	City	State
Australia	Repatriation General Hospital	Adelaide	South Australia
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Mater Adult Hospital	Brisbane	Queensland
Australia	Cairns Base Hospital	Cairns	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown Sydney	New South Wales
Australia	Canberra Hospital	Canberra	Australian Capital Territory
Australia	Peninsula Health Frankston Hospital	Frankston	Victoria
Australia	St George Hospital	Kogarah	New South Wales
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	John Hunter Hospital	Newcastle	New South Wales
Australia	AARI Sir Charles Gairdner Hospital	Perth	Western Australia
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Australia	Bankstown Hospital	Sydney	New South Wales
Australia	Burnside War Memorial Hospital	Toorak Gardens, Adelaide	South Australia
New Zealand	Greenlane Hospital	Auckland
New Zealand	Middlemore Hospital	Auckland
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Pharmaxis

Countries where clinical trial is conducted

Australia,  New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour sputum clearance		24 hours / 12 weeks	No
Primary	Quality of Life SGRQ		12 weeks	No
Secondary	bronchiectasis symptoms		12 weeks	No
Secondary	cough severity		12 weeks	No
Secondary	exercise capacity		12 weeks	No
Secondary	lung function, including gas transfer		12 weeks	No
Secondary	antibiotic use		12 weeks	No
Secondary	bronchial wall thickening and inflammation		12 weeks	No
Secondary	adverse events		12 weeks / 12 months	Yes
Secondary	haematology, biochemistry,		12 weeks / 12 months	Yes
Secondary	sputum microbiology quantitative and qualitative		12 weeks / 12 months	Yes