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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian J Lipworth, University of Dundee
ClinicalTrials.gov Identifier:
NCT00921921
First received: June 16, 2009
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
COPD
 Drug: HFA-BDP
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Extra-fine HFA-BDP Suppress Small Airways Inflammation in COPD?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • Alveolar Nitric Oxide [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: June 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921921

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

Additional Information:
Unit website  This link exits the ClinicalTrials.gov site

No publications provided by University of Dundee

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Brian J Lipworth, Professor, University of Dundee
ClinicalTrials.gov Identifier: NCT00921921     History of Changes
Other Study ID Numbers: PAW002
Study First Received: June 16, 2009
Last Updated: June 11, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013