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

November 14, 2013 updated by: Emory University

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Registration Dates

First Submitted

February 4, 2008

First Submitted That Met QC Criteria

February 4, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

November 18, 2013

Last Update Submitted That Met QC Criteria

November 14, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00001136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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