A Pilot Evaluation of the Impact of Alcohol Use on Airway Inflammation and Mechanics in Asthmatics
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Measurements of airway oxidative stress (increased GSSG/GS, and RNS/NO ratios and higher exhaled 8-isoprostanes levels)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Measurements of airway oxidative stress (increased GSSG/GS, and RNS/NO ratios and higher exhaled 8-isoprostanes levels)
时间窗: single timepoint
次要结局
- Measurements of lung function (spirometry, response to methacholine challenge, and impulse oscillometry).(single timepoint)
- Asthma symptoms and control through standard asthma questionnaires(single timepoint)