Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment (smoker3)
研究概览
地位
条件
详细说明
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).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Florida
-
Miami、Florida、美国、33136
- University of Miami School of Medicine
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:smokers
participants with smoking history ( > 10 pack/year) will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation
|
participants will performed echocardiogram before and 15 minutes after inhaled albuterol
participants will performed echocardiogram before and 15 minutes after inhaled albuterol
其他名称:
participant will be received a 4-week course of inhaled fluticasone (220 μg fluticasone twice a day administered as a MDI using a spacer)
participant will be received a 4-week course of identically appearing placebo (2 puffs twice a day via spacer).
|
实验性的:non-smokers
healthy life-time non smokers will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation
|
participants will performed echocardiogram before and 15 minutes after inhaled albuterol
participants will performed echocardiogram before and 15 minutes after inhaled albuterol
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Airway Blood Flow
大体时间: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
|
before and 15 minutes after albuterol inhalation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Echocardiogram
大体时间:MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers
|
to compare inhaled albuterol-induced changes in echocardiogram measuring mean pulmonary artery pressure (MPAP)in healthy current smokers and lifetime non-smokers as an index of endothelial function in the pulmonary circulation and to compare the results between smokers and non-smokers
|
MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
echocardiogram plus albuterol的临床试验
-
InBios International, Inc.Biomedical Advanced Research and Development Authority; Fast-Track Drugs & Biologics, LLC完全的
-
Azienda Sanitaria Locale Napoli 2 Nord招聘中
-
Zona Health, IncResearch & Development Concierge Company终止
-
Fondazione Policlinico Universitario Agostino Gemelli...尚未招聘尿路感染 | 输尿管支架相关症状
-
Yonsei University尚未招聘