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

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ClinicalTrials.gov Identifier: NCT00238082
Recruitment Status : Terminated
First Posted : October 13, 2005
Last Update Posted : March 29, 2017
Sponsor:
Information provided by:
National Jewish Health

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.

Condition or disease Intervention/treatment
COPD Drug: HFA-134A Beclomethasone DIpropionate (QVAR)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of HFA-beclomethasone Dipropionate on Static Lung Volumes in COPD
Actual Study Start Date : November 1999
Primary Completion Date : February 2005
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Spirometric response (FEV1)
  2. Lung volumes such as residual volume (RV), thoracic gas volume, total lung capacity (TLC) and the RV/TLC ratio


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00238082     History of Changes
Other Study ID Numbers: HS-1277
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by National Jewish Health:
COPD
Chronic Obstructive Pulmonary Disease
Emphysema
Chronic Bronchitis

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Beclomethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents