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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: September 24, 2014
Last verified: September 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

ClinicalTrials.gov Identifier: NCT00238082     History of Changes
Other Study ID Numbers: HS-1277
Study First Received: October 11, 2005
Last Updated: September 24, 2014
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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Beclomethasone
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014