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Safety and Efficacy of Bronchitol in Bronchiectasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00277537
Recruitment Status : Completed
First Posted : January 16, 2006
Last Update Posted : August 29, 2008
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Drug: Mannitol Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : March 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Mannitol

Arm Intervention/treatment
Experimental: 1 Drug: Mannitol
320mg BD 12 weeks followed by 40 weeks open label

2 Drug: placebo
BD for 12 weeks

Primary Outcome Measures :
  1. 24 hour sputum clearance [ Time Frame: 24 hours / 12 weeks ]
  2. Quality of Life SGRQ [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. bronchiectasis symptoms [ Time Frame: 12 weeks ]
  2. cough severity [ Time Frame: 12 weeks ]
  3. exercise capacity [ Time Frame: 12 weeks ]
  4. lung function, including gas transfer [ Time Frame: 12 weeks ]
  5. antibiotic use [ Time Frame: 12 weeks ]
  6. bronchial wall thickening and inflammation [ Time Frame: 12 weeks ]
  7. adverse events [ Time Frame: 12 weeks / 12 months ]
  8. haematology, biochemistry, [ Time Frame: 12 weeks / 12 months ]
  9. sputum microbiology quantitative and qualitative [ Time Frame: 12 weeks / 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00277537

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Sponsors and Collaborators
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Study Director: Brett Charlton Pharmaxis Ltd Australia
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr Brett Charlton, Pharmaxis Ltd Identifier: NCT00277537    
Other Study ID Numbers: DPM-B-301
First Posted: January 16, 2006    Key Record Dates
Last Update Posted: August 29, 2008
Last Verified: August 2008
Keywords provided by Pharmaxis:
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs