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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00238082
First Posted: October 13, 2005
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Jewish Health
October 11, 2005
October 13, 2005
March 29, 2017
November 1999
February 2005   (Final data collection date for primary outcome measure)
  • Spirometric response (FEV1)
  • Lung volumes such as residual volume (RV), thoracic gas volume, total lung capacity (TLC) and the RV/TLC ratio
Same as current
Complete list of historical versions of study NCT00238082 on ClinicalTrials.gov Archive Site
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The Effect of QVAR on Lung Functioning in Chronic Obstructive Pulmonary Disease
The Effect of HFA-beclomethasone Dipropionate on Static Lung Volumes in COPD
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.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
COPD
Drug: HFA-134A Beclomethasone DIpropionate (QVAR)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
February 2005
February 2005   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
45 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00238082
HS-1277
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National Jewish Health
Not Provided
Principal Investigator: Richard Martin, MD National Jewish Medical and Research Center faculty
National Jewish Health
March 2017

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