跳至主要内容
临床试验/NCT02141633
NCT02141633已完成不适用

Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment

University of Miami1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Airway Blood Flow

研究概览

简要总结

The purposes of the present proposal are to 1) compare inhaled albuterol-induced changes in airway blood flow (Qaw), and in CO and Ppas in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway and pulmonary circulations, 2) compare the results between smokers and non-smokers, and 3) determine the effect of a 4-week treatment with an ICS on albuterol responsiveness of Qaw and the echocardiographic parameters. With this protocol the Investigators will test the hypotheses that a) there is a correlation between airway and pulmonary vascular endothelial function within the current smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular endothelial function in the current smoker group.

详细描述

With this protocol the Investigators will test the hypotheses that a) there is a correlation between airway and pulmonary vascular endothelial function within the current smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular endothelial function in the current smoker group.

Fifteen healthy current smokers with a >10 pack-year history of smoking and 15 healthy never-smokers will be enrolled. Males and females between 25 and 75 years of age will be recruited There will be 1-4 visits to the laboratory (one for non-smokers, 4 for smokers). All subjects will have the first visit. Current smokers will have 3 additional visits. Current smokers will be asked not to smoke before coming to the laboratory on the 3 study days. All subjects will be instructed to abstain from ingesting alcoholic beverages, coffee or caffeinated drinks for at least 12 hours the night before each study day. The subjects will also be instructed not to use PDE5 inhibitors for 24 hours before coming to the laboratory. On each study day, the protocol will start at the same time (in the morning).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fifteen healthy current smokers with a >10 pack-year history of smoking and 15 healthy never-smokers will be enrolled. Males and females between 25 and 75 years of age will be recruited.

排除标准

  • Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women
  • Cardiovascular disease and/or use of cardiovascular medications
  • Subjects with known beta-adrenergic agonist intolerance
  • A physician diagnosis of chronic airway disease (asthma, COPD, bronchiectasis, cystic fibrosis)
  • Acute respiratory infection within four weeks prior to the study
  • Use of any airway medication
  • Abnormal pulmonary function

研究组 & 干预措施

smokers

Experimental

participants with smoking history ( > 10 pack/year) will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation

干预措施: echocardiogram plus albuterol (Procedure)

smokers

Experimental

participants with smoking history ( > 10 pack/year) will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation

干预措施: airway blood flow plus albuterol (Procedure)

smokers

Experimental

participants with smoking history ( > 10 pack/year) will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation

干预措施: Fluticasone propionate (Drug)

smokers

Experimental

participants with smoking history ( > 10 pack/year) will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation

干预措施: placebo (Drug)

non-smokers

Experimental

healthy life-time non smokers will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation

干预措施: echocardiogram plus albuterol (Procedure)

non-smokers

Experimental

healthy life-time non smokers will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation

干预措施: airway blood flow plus albuterol (Procedure)

结局指标

主要结局

Airway Blood Flow

时间窗: before and 15 minutes after albuterol inhalation

compare inhaled albuterol-induced changes in airway blood flow (ΔQaw) in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway circulation and to compare the results between smokers and non-smokers

次要结局

  • Echocardiogram(MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam Wanner

Research Professor

University of Miami

研究点 (1)

Loading locations...

相似试验