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

This study has been withdrawn prior to enrollment.
(Dr. Holguin is relocating.)
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00615407
First received: February 4, 2008
Last updated: July 15, 2008
Last verified: July 2008
History of Changes
  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

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional

Resource links provided by NLM:

MedlinePlus related topics: Alcohol Asthma
U.S. FDA Resources

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

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

No publications provided

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

Keywords provided by Emory University:
Asthma, alcohol

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013