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

This study has been terminated.

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

Sponsor:	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)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	The Effect of HFA-Beclomethasone Dipropionate on Static Lung Volumes in COPD

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: HFA 227 Beclomethasone Beclomethasone dipropionate

U.S. FDA Resources

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

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

Keywords provided by National Jewish Health:

COPD
Chronic Obstructive Pulmonary Disease
Emphysema
Chronic Bronchitis

Additional relevant MeSH terms:

Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Beclomethasone
Anti-Inflammatory Agents
Therapeutic Uses

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

ClinicalTrials.gov processed this record on February 12, 2012