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

This study has been terminated.
Sponsor:
Information provided by:
National Jewish Health
ClinicalTrials.gov Identifier:
NCT00238082
First received: October 11, 2005
Last updated: January 5, 2009
Last verified: February 2005
History of Changes
  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:

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 May 21, 2013