Safety and Efficacy of Bronchitol in Bronchiectasis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Bronchiectasis	Drug: Mannitol Drug: placebo	Phase 3

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

Resource links provided by NLM:

Drug Information available for: Mannitol

U.S. FDA Resources

Further study details as provided by Pharmaxis:

Primary Outcome Measures:

24 hour sputum clearance [ Time Frame: 24 hours / 12 weeks ] [ Designated as safety issue: No ]
Quality of Life SGRQ [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

bronchiectasis symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
cough severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
exercise capacity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
lung function, including gas transfer [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
antibiotic use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
bronchial wall thickening and inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
adverse events [ Time Frame: 12 weeks / 12 months ] [ Designated as safety issue: Yes ]
haematology, biochemistry, [ Time Frame: 12 weeks / 12 months ] [ Designated as safety issue: Yes ]
sputum microbiology quantitative and qualitative [ Time Frame: 12 weeks / 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	354
Study Start Date:	March 2006
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Mannitol 320mg BD 12 weeks followed by 40 weeks open label
2	Drug: placebo BD for 12 weeks

Eligibility

Ages Eligible for Study:	15 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277537

Locations

Australia, Australian Capital Territory
Canberra Hospital
Canberra, Australian Capital Territory, Australia
Australia, New South Wales
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
Australia, Queensland
Mater Adult Hospital
Brisbane, Queensland, Australia
Cairns Base Hospital
Cairns, Queensland, Australia
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Repatriation General Hospital
Adelaide, South Australia, Australia
Burnside War Memorial Hospital
Toorak Gardens, Adelaide, South Australia, Australia
Australia, Victoria
Peninsula Health Frankston Hospital
Frankston, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia
AARI Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
New Zealand
Greenlane Hospital
Auckland, New Zealand
Middlemore Hospital
Auckland, New Zealand
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, United Kingdom

Sponsors and Collaborators

Pharmaxis

Investigators

Study Director:

Brett Charlton

Pharmaxis Ltd Australia

More Information

No publications provided

Responsible Party:	Dr Brett Charlton, Pharmaxis Ltd
ClinicalTrials.gov Identifier:	NCT00277537 History of Changes
Other Study ID Numbers:	DPM-B-301
Study First Received:	January 13, 2006
Last Updated:	August 27, 2008
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency New Zealand: Health and Disability Ethics Committees

Keywords provided by Pharmaxis:

Mannitol

Additional relevant MeSH terms:

Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Mannitol
Diuretics, Osmotic
Diuretics

Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013