A Pilot Evaluation of the Impact of Alcohol Use on Airway Inflammation and Mechanics in Asthmatics

Asthma Clinical Trial

— AIM Asthma  

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00615407
• Other study ID #: IRB00001136
• Status: Withdrawn
• Phase: N/A
• First received: February 4, 2008
• Last updated: November 14, 2013
• Start date: January 2007

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurements of airway oxidative stress (increased GSSG/GS, and RNS/NO ratios and higher exhaled 8-isoprostanes levels)		single timepoint	No
Secondary	Measurements of lung function (spirometry, response to methacholine challenge, and impulse oscillometry).		single timepoint	No
Secondary	Asthma symptoms and control through standard asthma questionnaires		single timepoint	No