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

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National Jewish Health

Status

Terminated

Conditions

COPD

Treatments

Drug: HFA-134A Beclomethasone DIpropionate (QVAR)

Study type

Interventional

Funder types

Other

Identifiers

NCT00238082
HS-1277

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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