A Pilot Evaluation of the Impact of Alcohol Use on Airway Inflammation and Mechanics in Asthmatics - Full Text View

Sponsors and Collaborators:	Emory University National Institutes of Health (NIH)
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00615407

Purpose

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.

Condition
Asthma

MedlinePlus related topics: Alcohol Consumption Asthma

Drug Information available for: Ethanol

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cross-Sectional

Further study details as provided by Emory University:

Primary Outcome Measures:

Measurements of airway oxidative stress (increased GSSG/GS, and RNS/NO ratios and higher exhaled 8-isoprostanes levels) [ Time Frame: single timepoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measurements of lung function (spirometry, response to methacholine challenge, and impulse oscillometry). [ Time Frame: single timepoint ] [ Designated as safety issue: No ]
Asthma symptoms and control through standard asthma questionnaires [ Time Frame: single timepoint ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Blood, urine, and exhaled breath condensate

Estimated Enrollment:	40
Study Start Date:	January 2007

Groups/Cohorts
Alcohol Drinkers Asthmatics who consume 3 or more alcoholic beverages per day (on average)
Non Drinkers Asthmatics who do not drink alcohol or consume less than or equal to 2 alcoholic beverages per month

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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).

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)

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Emory University ( Fernando Holguin, MD, MPH )
Study ID Numbers:	00001136
Study First Received:	February 4, 2008
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00615407
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

Asthma, alcohol

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate

Asthma
Alcohol Drinking
Ethanol
Respiratory Hypersensitivity
Inflammation

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 14, 2009