- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00238082
The Effect of QVAR on Lung Functioning in Chronic Obstructive Pulmonary Disease
March 27, 2017 updated by: National Jewish Health
The Effect of HFA-beclomethasone Dipropionate on Static Lung Volumes in COPD
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Colorado
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Denver, Colorado, United States, 80206
- National Jewish Medical and Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
43 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Spirometric response (FEV1)
|
Lung volumes such as residual volume (RV), thoracic gas volume, total lung capacity (TLC) and the RV/TLC ratio
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard Martin, MD, National Jewish Medical and Research Center faculty
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 1999
Primary Completion (Actual)
February 1, 2005
Study Completion (Actual)
February 1, 2005
Study Registration Dates
First Submitted
October 11, 2005
First Submitted That Met QC Criteria
October 11, 2005
First Posted (Estimate)
October 13, 2005
Study Record Updates
Last Update Posted (Actual)
March 29, 2017
Last Update Submitted That Met QC Criteria
March 27, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Beclomethasone
- Norflurane
Other Study ID Numbers
- HS-1277
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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