The Effect of QVAR on Lung Functioning in Chronic Obstructive Pulmonary Disease
Information source: National Jewish Medical and Research Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: COPD
Intervention: HFA-134A Beclomethasone DIpropionate (QVAR) (Drug)
Phase: N/A
Status: Terminated
Sponsored by: National Jewish Medical and Research Center Official(s) and/or principal investigator(s):
Richard Martin, MD, Principal Investigator, Affiliation: National Jewish Medical and Research Center faculty
Summary
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.
Clinical Details
Official title: The Effect of HFA-Beclomethasone Dipropionate on Static Lung Volumes in COPD
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Spirometric response (FEV1)Lung volumes such as residual volume (RV), thoracic gas volume, total lung capacity (TLC) and the RV/TLC ratio
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
National Jewish Medical and Research Center, Denver, Colorado 80206, United States
Additional Information
clinical lab website within National Jewish Medical and Research Center
Starting date: November 1999
Ending date: February 2005
Last updated: June 21, 2006
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