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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 ]
  • Quality of Life SGRQ [ Time Frame: 12 weeks ]
  • 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 ]
  • cough severity [ Time Frame: 12 weeks ]
  • exercise capacity [ Time Frame: 12 weeks ]
  • lung function, including gas transfer [ Time Frame: 12 weeks ]
  • antibiotic use [ Time Frame: 12 weeks ]
  • bronchial wall thickening and inflammation [ Time Frame: 12 weeks ]
  • adverse events [ Time Frame: 12 weeks / 12 months ]
  • haematology, biochemistry, [ Time Frame: 12 weeks / 12 months ]
  • sputum microbiology quantitative and qualitative [ Time Frame: 12 weeks / 12 months ]
  • 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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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
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.

*   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
Sexes Eligible for Study: All
15 Years to 80 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   New Zealand,   United Kingdom
 
 
NCT00277537
DPM-B-301
Yes
Not Provided
Not Provided
Not Provided
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