Status:
COMPLETED
Safety and Efficacy of Bronchitol in Bronchiectasis
Lead Sponsor:
Syntara
Conditions:
Bronchiectasis
Eligibility:
All Genders
15-80 years
Phase:
PHASE3
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 infect...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT00277537
Start Date
March 1 2006
End Date
July 1 2008
Last Update
August 29 2008
Active Locations (22)
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1
Canberra Hospital
Canberra, Australian Capital Territory, Australia
2
Royal Prince Alfred Hospital
Camperdown Sydney, New South Wales, Australia
3
St George Hospital
Kogarah, New South Wales, Australia
4
John Hunter Hospital
Newcastle, New South Wales, Australia