The Effect of QVAR on Lung Functioning in Chronic Obstructive Pulmonary Disease

This study has been terminated.

First Received: October 11, 2005 Last Updated: January 5, 2009 History of Changes

Sponsored by:	National Jewish Health
Information provided by:	National Jewish Health
ClinicalTrials.gov Identifier:	NCT00238082

Purpose

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.

Condition	Intervention
COPD	Drug: HFA-134A Beclomethasone DIpropionate (QVAR)

MedlinePlus related topics: Bronchitis COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: HFA 227 Beclomethasone Beclomethasone dipropionate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of HFA-Beclomethasone Dipropionate on Static Lung Volumes in COPD

Further study details as provided by National Jewish Health:

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

Estimated Enrollment:	20
Study Start Date:	November 1999
Estimated Study Completion Date:	February 2005

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238082

Locations

United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206

Sponsors and Collaborators

National Jewish Health

Investigators

Principal Investigator:

Richard Martin, MD

National Jewish Medical and Research Center faculty

More Information

Additional Information:

clinical lab website within National Jewish Medical and Research Center This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	HS-1277
Study First Received:	October 11, 2005
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00238082 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by National Jewish Health:

COPD
Chronic Obstructive Pulmonary Disease
Emphysema
Chronic Bronchitis

Study placed in the following topic categories:

Anti-Inflammatory Agents
Emphysema
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Beclomethasone
Glucocorticoids
Hormones

Pulmonary Emphysema
Bronchitis, Chronic
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Bronchitis
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Beclomethasone
Anti-Asthmatic Agents
Glucocorticoids

Hormones
Pharmacologic Actions
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009