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

Tracking Information

First Received Date ^ICMJE

October 11, 2005

Last Updated Date

January 5, 2009

Start Date ^ICMJE

November 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Spirometric response (FEV1)
Lung volumes such as residual volume (RV), thoracic gas volume, total lung capacity (TLC) and the RV/TLC ratio

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00238082 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Effect of HFA-Beclomethasone Dipropionate on Static Lung Volumes in COPD

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

COPD

Intervention ^ICMJE

Drug: HFA-134A Beclomethasone DIpropionate (QVAR)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

February 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

45 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00238082

Responsible Party

Study ID Numbers ^ICMJE

HS-1277

Study Sponsor ^ICMJE

National Jewish Health

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Richard Martin, MD

National Jewish Medical and Research Center faculty

Information Provided By

National Jewish Health

Verification Date

February 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP