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OpenTrials
Completed

NCT Number: NCT00277537

Safety and Efficacy of Bronchitol in 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.

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Canberra Hospital, Canberra, Australian Capital Territory, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mannitol

Drug

320mg BD 12 weeks followed by 40 weeks open label

Placebo

Drug

BD for 12 weeks

Primary outcomes

  1. 24 hour sputum clearance

    Time frame: 24 hours / 12 weeks

  2. Quality of Life SGRQ

    Time frame: 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Syntara

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 16, 2006
Registry last updated
Aug 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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