Does Extra-fine Hydrofluoroalkane-beclomethasone Dipropionate (HFA-BDP) Suppress Small Airways Inflammation in Chronic Obstructive Pulmonary Disease (COPD)?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00921921
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : June 12, 2012
Information provided by (Responsible Party):
Brian J Lipworth, University of Dundee

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 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Extra-fine particle steroid inhaler Drug: HFA-BDP
HFA-BDP 100 mcg bid for 3 weeks, then 400 mcg bid for 3 weeks
Other Name: Qvar
Placebo Comparator: Placebo control Drug: Placebo
1 puff bid for 3 weeks, then 1 puff bid for 3 weeks

Primary Outcome Measures :
  1. Alveolar Nitric Oxide [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00921921

United Kingdom
Asthma and Allergy Research Group, University of Dundee
Dundee, Tayside, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Brian J Lipworth, Professor, University of Dundee Identifier: NCT00921921     History of Changes
Other Study ID Numbers: PAW002
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: June 12, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Pathologic Processes
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents