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

NCT00615407 | Withdrawn

• 1 other identifier: IRB00001136
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Keywords

Asthma, alcohol

Outcome Measures

Primary Outcomes (1)

• Measurements of airway oxidative stress (increased GSSG/GS, and RNS/NO ratios and higher exhaled 8-isoprostanes levels)

  single timepoint

Secondary Outcomes (2)

• Measurements of lung function (spirometry, response to methacholine challenge, and impulse oscillometry).

  single timepoint

• Asthma symptoms and control through standard asthma questionnaires

  single timepoint

Study Arms (2)

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 Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• National Institutes of Health (NIH): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, and exhaled breath condensate

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 14, 2008
• Study Start: January 1, 2007
• Last Updated: November 18, 2013

Record last verified: 2013-11