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.

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.

Conditions

• Bronchiectasis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

• Primary Outcomes: 24 hour sputum clearance; Quality of Life SGRQ
• Secondary Outcomes: 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

Study Start

March 2006; Expected completion: May 2007

Eligibility & Criteria

• Ages Eligible for Study: 15 Years – 80 Years
• Genders Eligible for Study: Both

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

Total Enrolment

354 (expected)

Contact Details

Anna Lassig, BSc MPH 02 94547 218 anna.lassig@pharmaxis.com.au