Clinical trial NCT00615407: A Pilot Evaluation of the Impact of Alcohol Use on Airway Inflammation and Mechanics in Asthmatics
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Asthma
Keywords: Asthma, alcohol
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-02-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For this study, 40 non-smoking adults with asthma will be recruited-50% will be non-drinking and 50% will be heavy alcohol users (≥3 standard drinks/day on average).

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Measurements of airway oxidative stress (increased GSSG/GS, and RNS/NO ratios and higher exhaled 8-isoprostanes levels)
timeFrame: single timepoint
Secondary outcomes:
measure: Measurements of lung function (spirometry, response to methacholine challenge, and impulse oscillometry).
timeFrame: single timepoint
measure: Asthma symptoms and control through standard asthma questionnaires
timeFrame: single timepoint
Other outcomes:
Locations:
Study officials:
References: