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Safety and Efficacy of Bronchitol in Bronchiectasis

This study has been completed.
Sponsor:
Information provided by:
Pharmaxis
ClinicalTrials.gov Identifier:
NCT00277537
First received: January 13, 2006
Last updated: August 27, 2008
Last verified: August 2008

January 13, 2006
August 27, 2008
March 2006
July 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • 24 hour sputum clearance
  • Quality of Life SGRQ
Complete list of historical versions of study NCT00277537 on ClinicalTrials.gov Archive Site
  • 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 ]
  • bronchiectasis symptoms
  • cough severity
  • exercise capacity
  • lung function, including gas transfer
  • antibiotic use
  • bronchial wall thickening and inflammation
  • peripheral airway function
  • adverse events
  • haematology, biochemistry,
  • sputum microbiology
Not Provided
Not Provided
 
Safety and Efficacy of Bronchitol in Bronchiectasis
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bronchiectasis
  • Drug: Mannitol
    320mg BD 12 weeks followed by 40 weeks open label
  • Drug: placebo
    BD for 12 weeks
  • Experimental: 1
    Intervention: Drug: Mannitol
  • 2
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
354
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
15 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   New Zealand,   United Kingdom
 
NCT00277537
DPM-B-301
Yes
Dr Brett Charlton, Pharmaxis Ltd
Pharmaxis
Not Provided
Study Director: Brett Charlton Pharmaxis Ltd Australia
Pharmaxis
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP