Status:
COMPLETED
Does Extra-fine Hydrofluoroalkane-beclomethasone Dipropionate (HFA-BDP) Suppress Small Airways Inflammation in Chronic Obstructive Pulmonary Disease (COPD)?
Lead Sponsor:
University of Dundee
Conditions:
COPD
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
Chronic obstructive pulmonary disease or 'COPD' is a chronic disease, which means that it cannot be cured, but that inhalers and tablets can be used to control the symptoms. In COPD, the airways becom...
Eligibility Criteria
Inclusion
- Current or ex-smokers
- \> 40 years of age with a greater than 15 pack year history of smoking
- post-bronchodilator FEV1/FVC ratio \< 0.7
- FEV1 \< 80% predicted
- CANO \> 3 ppb at screening
- Informed consent and ability to perform exhaled nitric oxide assessment
Exclusion
- Oral steroid use or exacerbation within 6 weeks
- Greater than 2 exacerbations requiring treatment in the previous 6 months
- Requirement for domiciliary oxygen
- Pregnancy or lactation
- Known or suspected contra-indication to any of the IMP's
- Diagnosis of asthma
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00921921
Start Date
June 1 2009
End Date
October 1 2011
Last Update
April 12 2019
Active Locations (1)
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1
Asthma and Allergy Research Group, University of Dundee
Dundee, Tayside, United Kingdom, DD1 9SY