A Pilot Evaluation of the Impact of Alcohol Use on Airway Inflammation and Mechanics in Asthmatics (AIM Asthma)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00615407
Recruitment Status : Withdrawn (Dr. Holguin is relocating.)
First Posted : February 14, 2008
Last Update Posted : November 18, 2013
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Emory University

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.

Condition or disease

Study Type : Observational
Actual Enrollment : 0 participants
Time Perspective: Cross-Sectional
Study Start Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Measurements of airway oxidative stress (increased GSSG/GS, and RNS/NO ratios and higher exhaled 8-isoprostanes levels) [ Time Frame: single timepoint ]

Secondary Outcome Measures :
  1. Measurements of lung function (spirometry, response to methacholine challenge, and impulse oscillometry). [ Time Frame: single timepoint ]
  2. Asthma symptoms and control through standard asthma questionnaires [ Time Frame: single timepoint ]

Biospecimen Retention:   Samples With DNA
Blood, urine, and exhaled breath condensate

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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).

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)

Responsible Party: Emory University Identifier: NCT00615407     History of Changes
Other Study ID Numbers: IRB00001136
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: November 18, 2013
Last Verified: November 2013

Keywords provided by Emory University:
Asthma, alcohol

Additional relevant MeSH terms:
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs