Does Extra-fine Hydrofluoroalkane-beclomethasone Dipropionate (HFA-BDP) Suppress Small Airways Inflammation in Chronic Obstructive Pulmonary Disease (COPD)?
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|ClinicalTrials.gov Identifier: NCT00921921|
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : June 12, 2012
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 become inflamed which can cause coughing and make the airways tighten. This 'inflammation' is the root of the problem in COPD.
The airways of the lung start in the windpipe and branch like the branches of a tree, getting smaller and smaller. In COPD the inflammation is deep in the lungs, out to the very small airways.
Different inhalers make the medicines into different sized particles. Most steroid inhalers used for COPD make the medicine into particles which are too big to get into the very small airways ('coarse particles'). Other inhalers make a mist, with much smaller particles ('fine particles'). These are as small as the smallest airways in the lungs.
Doctors have recently found a way to measure the inflammation in the small airways that are affected in COPD. The investigators want to find out if taking one of these 'fine-particle' steroid inhalers can treat that inflammation.
|Condition or disease||Intervention/treatment||Phase|
|COPD||Drug: HFA-BDP Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Does Extra-fine HFA-BDP Suppress Small Airways Inflammation in COPD?|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
|Experimental: Extra-fine particle steroid inhaler||
HFA-BDP 100 mcg bid for 3 weeks, then 400 mcg bid for 3 weeks
Other Name: Qvar
|Placebo Comparator: Placebo control||
1 puff bid for 3 weeks, then 1 puff bid for 3 weeks
- Alveolar Nitric Oxide [ Time Frame: 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921921
|Asthma and Allergy Research Group, University of Dundee|
|Dundee, Tayside, United Kingdom, DD1 9SY|