Safety and Efficacy of Bronchitol in Bronchiectasis

August 27, 2008 updated by: Pharmaxis

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

354

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia
        • Canberra Hospital
    • New South Wales
      • Camperdown Sydney, New South Wales, Australia
        • Royal Prince Alfred Hospital
      • Kogarah, New South Wales, Australia
        • St George Hospital
      • Newcastle, New South Wales, Australia
        • John Hunter Hospital
      • St Leonards, New South Wales, Australia
        • Royal North Shore Hospital
      • Sydney, New South Wales, Australia
        • Bankstown Hospital
    • Queensland
      • Brisbane, Queensland, Australia
        • Mater Adult Hospital
      • Cairns, Queensland, Australia
        • Cairns Base Hospital
    • South Australia
      • Adelaide, South Australia, Australia
        • Royal Adelaide Hospital
      • Adelaide, South Australia, Australia
        • Repatriation General Hospital
      • Toorak Gardens, Adelaide, South Australia, Australia
        • Burnside War Memorial Hospital
    • Victoria
      • Frankston, Victoria, Australia
        • Peninsula Health Frankston Hospital
      • Melbourne, Victoria, Australia
        • The Alfred Hospital
    • Western Australia
      • Perth, Western Australia, Australia
        • Royal Perth Hospital
      • Perth, Western Australia, Australia
        • AARI Sir Charles Gairdner Hospital
  • New Zealand
      • Auckland, New Zealand
        • Middlemore Hospital
      • Auckland, New Zealand
        • Greenlane Hospital
  • United Kingdom
      • Cambridge, United Kingdom
        • Papworth Hospital
      • Leicester, United Kingdom
        • Glenfield Hospital
      • Manchester, United Kingdom
        • North West Lung Centre, Wythshawe Hospital
      • Norwich, United Kingdom
        • Norfolk and Norwich University Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom
        • Belfast City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Mannitol
320mg BD 12 weeks followed by 40 weeks open label
Other: 2
Drug: placebo
BD for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24 hour sputum clearance
Time Frame: 24 hours / 12 weeks
24 hours / 12 weeks
Quality of Life SGRQ
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
bronchiectasis symptoms
Time Frame: 12 weeks
12 weeks
cough severity
Time Frame: 12 weeks
12 weeks
exercise capacity
Time Frame: 12 weeks
12 weeks
lung function, including gas transfer
Time Frame: 12 weeks
12 weeks
antibiotic use
Time Frame: 12 weeks
12 weeks
bronchial wall thickening and inflammation
Time Frame: 12 weeks
12 weeks
adverse events
Time Frame: 12 weeks / 12 months
12 weeks / 12 months
haematology, biochemistry,
Time Frame: 12 weeks / 12 months
12 weeks / 12 months
sputum microbiology quantitative and qualitative
Time Frame: 12 weeks / 12 months
12 weeks / 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmaxis

Investigators

  • Study Director: Brett Charlton, Pharmaxis Ltd Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

January 13, 2006

First Submitted That Met QC Criteria

January 13, 2006

First Posted (Estimate)

January 16, 2006

Study Record Updates

Last Update Posted (Estimate)

August 29, 2008

Last Update Submitted That Met QC Criteria

August 27, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPM-B-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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