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Safety and Efficacy of Bronchitol in Bronchiectasis

Primary Purpose

Bronchiectasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mannitol
placebo
Sponsored by
Pharmaxis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Mannitol

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Canberra Hospital
  • Royal Prince Alfred Hospital
  • St George Hospital
  • John Hunter Hospital
  • Royal North Shore Hospital
  • Bankstown Hospital
  • Mater Adult Hospital
  • Cairns Base Hospital
  • Repatriation General Hospital
  • Royal Adelaide Hospital
  • Burnside War Memorial Hospital
  • Peninsula Health Frankston Hospital
  • The Alfred Hospital
  • AARI Sir Charles Gairdner Hospital
  • Royal Perth Hospital
  • Greenlane Hospital
  • Middlemore Hospital
  • Belfast City Hospital
  • Papworth Hospital
  • Glenfield Hospital
  • North West Lung Centre, Wythshawe Hospital
  • Norfolk and Norwich University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

24 hour sputum clearance
Quality of Life SGRQ

Secondary Outcome Measures

bronchiectasis symptoms
cough severity
exercise capacity
lung function, including gas transfer
antibiotic use
bronchial wall thickening and inflammation
adverse events
haematology, biochemistry,
sputum microbiology quantitative and qualitative

Full Information

First Posted
January 13, 2006
Last Updated
August 27, 2008
Sponsor
Pharmaxis
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1. Study Identification

Unique Protocol Identification Number
NCT00277537
Brief Title
Safety and Efficacy of Bronchitol in Bronchiectasis
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pharmaxis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Mannitol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
354 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Mannitol
Intervention Description
320mg BD 12 weeks followed by 40 weeks open label
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
BD for 12 weeks
Primary Outcome Measure Information:
Title
24 hour sputum clearance
Time Frame
24 hours / 12 weeks
Title
Quality of Life SGRQ
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
bronchiectasis symptoms
Time Frame
12 weeks
Title
cough severity
Time Frame
12 weeks
Title
exercise capacity
Time Frame
12 weeks
Title
lung function, including gas transfer
Time Frame
12 weeks
Title
antibiotic use
Time Frame
12 weeks
Title
bronchial wall thickening and inflammation
Time Frame
12 weeks
Title
adverse events
Time Frame
12 weeks / 12 months
Title
haematology, biochemistry,
Time Frame
12 weeks / 12 months
Title
sputum microbiology quantitative and qualitative
Time Frame
12 weeks / 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett Charlton
Organizational Affiliation
Pharmaxis Ltd Australia
Official's Role
Study Director
Facility Information:
Facility Name
Canberra Hospital
City
Canberra
State/Province
Australian Capital Territory
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown Sydney
State/Province
New South Wales
Country
Australia
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
Country
Australia
Facility Name
John Hunter Hospital
City
Newcastle
State/Province
New South Wales
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
Country
Australia
Facility Name
Bankstown Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Mater Adult Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Cairns Base Hospital
City
Cairns
State/Province
Queensland
Country
Australia
Facility Name
Repatriation General Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Burnside War Memorial Hospital
City
Toorak Gardens, Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Peninsula Health Frankston Hospital
City
Frankston
State/Province
Victoria
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
AARI Sir Charles Gairdner Hospital
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Greenlane Hospital
City
Auckland
Country
New Zealand
Facility Name
Middlemore Hospital
City
Auckland
Country
New Zealand
Facility Name
Belfast City Hospital
City
Belfast
State/Province
Northern Ireland
Country
United Kingdom
Facility Name
Papworth Hospital
City
Cambridge
Country
United Kingdom
Facility Name
Glenfield Hospital
City
Leicester
Country
United Kingdom
Facility Name
North West Lung Centre, Wythshawe Hospital
City
Manchester
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23429964
Citation
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.
Results Reference
derived

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Safety and Efficacy of Bronchitol in Bronchiectasis

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