This is an investigator-sponsored research study to evaluate if treatment with HFA-134a beclomethasone (QVAR) has an effect on peripheral (or outer) airway inflammation and airway “remodeling” or scarring in subjects with COPD. Approximately 20 subjects with COPD will participate for approximately 7 weeks, with 10 receiving an active (BDP) inhaler with HFA-134a and 10 receiving a placebo...
Date First Received: October 11, 2005
Last Updated: June 21, 2006
Verified by: National Jewish Medical and Research Center, February 2005
Clinical Trial Phase: N/A | Start Date: November 1999
Overall Status: Terminated
Estimated Enrollment: 20
Brief Summary
Official Title: “The Effect of HFA-Beclomethasone Dipropionate on Static Lung Volumes in COPD”
Condition Keyword(s):
Intervention(s):
This is an investigator-sponsored research study to evaluate if treatment with HFA-134a beclomethasone (QVAR) has an effect on peripheral (or outer) airway inflammation and airway “remodeling” or scarring in subjects with COPD. Approximately 20 subjects with COPD will participate for approximately 7 weeks, with 10 receiving an active (BDP) inhaler with HFA-134a and 10 receiving a placebo.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: HFA-134A Beclomethasone DIpropionate (QVAR)
Outcome Measures for this Clinical Trial
Primary Measures
- Spirometric response (FEV1)
- Lung volumes such as residual volume (RV), thoracic gas volume, total lung capacity (TLC) and the RV/TLC ratio
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- COPD diagnosis
- FEV1/FVC<70%
- FEV1 50-80% predicted
- Albuterol response of <12% and <200mL or methacholine PC20 > 8mg/mL
- RV > 120% predicted
- DLCO < 80%
- smokers and nonsmokers
- Lower age limit 45 years
Exclusion Criteria:
- Asthma
- Other chronic airway or parenchymal lung disease
- Other comorbid illness (including but not limited to DM, MI or CAD-related intervention in 6 months, neurologic disease, syncope)
- Use of any steroid (oral, IV, nasal, pulmonary) within 12 weeks
- Use of theophylline, leukotriene modifiers within 12 weeks
- Use of long-acting beta-agonists (formoterol, salmeterol) or anticholinergic (tiotropium)
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 45 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: National Jewish Medical and Research Center
Overall Clinical Trial Officials and Contacts
Richard Martin, MD Principal Investigator National Jewish Medical and Research Center faculty
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00238082
Study ID Number: HS-1277
ClinicalTrials.gov Identifier: NCT00238082
Health Authority: United States: Institutional Review Board
clinical lab website within National Jewish Medical and Research Center
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