A Pilot Evaluation of the Impact of Alcohol Use on Airway Inflammation and Mechanics in Asthmatics

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Brief Summary

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Since 1980, the number of people in the United States diagnosed with asthma has increased dramatically. Studying what causes and triggers asthma is an important part of understanding and subsequently managing this disease. Although some have suggested that alcohol consumption may affect asthma, little is known about how consistent alcohol use affects the amount of inflammation present in the lungs and whether consistent alcohol use makes the airways more narrow and stiff.

Participation in this study involves 2 visits in order to complete questionnaires, various pulmonary function tests, as well as the collection of blood, urine, and exhaled breath condensate specimens.

This study includes optional genetic and bronchoscopy substudies.

Detailed Description

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Conditions

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Asthma

Keywords

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Asthma, alcohol

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Alcohol Drinkers

Asthmatics who consume 3 or more alcoholic beverages per day (on average)

No interventions assigned to this group

Non Drinkers

Asthmatics who do not drink alcohol or consume less than or equal to 2 alcoholic beverages per month

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18 to 65 years of age
* Literate in English (i.e., read study materials at 6th grade level) so as to understand, and complete the ratings scales and questionnaires accurately
* Physician-diagnosed asthma requiring treatment in the past year with a post bronchodilator FEV1/FVC \>0.70 and at least 12% reversibility after bronchodilator usage
* Alcohol usage groups: 1) those who rarely or who do not drink alcohol (≤2 drinks per month); or 2) those who drink 3 or more alcoholic beverages per day on average

Exclusion Criteria

* Social drinkers (\>2 drinks in a month but \<3 drinks per day)
* Asthma exacerbation within the past month
* Current upper respiratory infection
* Active allergies with uncontrolled symptoms
* Current DSM-IV diagnosis of illicit substance dependence (not alcohol)
* History of serious pulmonary problems other than asthma
* Other significant non-pulmonary comorbidities
* Pregnancy or currently lactating
* Daily use of Prednisone or other corticosteroids
* Tobacco smoking within the past year or \>10 life-time pack-years of smoking
* Positive breath alcohol level at the time of the study assessments
* Positive urine cotinine test at enrollment (indicates nicotine usage)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

Other Identifiers

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IRB00001136

Identifier Type: -

Identifier Source: org_study_id