Back to resultsThe Effect of QVAR on Lung Functioning in Chronic Obstructive Pulmonary Disease
Primary Purpose
COPD
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HFA-134A Beclomethasone DIpropionate (QVAR)
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring COPD, Chronic Obstructive Pulmonary Disease, Emphysema, Chronic Bronchitis
Eligibility 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)
Sites / Locations
- National Jewish Medical and Research Center
Outcomes
Primary Outcome Measures
Spirometric response (FEV1)
Lung volumes such as residual volume (RV), thoracic gas volume, total lung capacity (TLC) and the RV/TLC ratio
Secondary Outcome Measures
Full Information
NCT ID
NCT00238082
First Posted
October 11, 2005
Last Updated
March 27, 2017
Sponsor
National Jewish Health
1. Study Identification
Unique Protocol Identification Number
NCT00238082
Brief Title
The Effect of QVAR on Lung Functioning in Chronic Obstructive Pulmonary Disease
Official Title
The Effect of HFA-beclomethasone Dipropionate on Static Lung Volumes in COPD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Study Start Date
November 1999 (Actual)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Jewish Health
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
COPD, Chronic Obstructive Pulmonary Disease, Emphysema, Chronic Bronchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
HFA-134A Beclomethasone DIpropionate (QVAR)
Primary Outcome Measure Information:
Title
Spirometric response (FEV1)
Title
Lung volumes such as residual volume (RV), thoracic gas volume, total lung capacity (TLC) and the RV/TLC ratio
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Martin, MD
Organizational Affiliation
National Jewish Medical and Research Center faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Jewish Medical and Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.nationaljewish.org/programs/directory/copd/
Description
clinical lab website within National Jewish Medical and Research Center
Learn more about this trial
The Effect of QVAR on Lung Functioning in Chronic Obstructive Pulmonary Disease
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