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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-11-30

Study Completion Date

2005-02-28

Brief Summary

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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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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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HFA-134A Beclomethasone DIpropionate (QVAR)

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No