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Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment (smoker3)

2016年10月25日 更新者:Adam Wanner、University of Miami
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.

研究概览

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

介入性

注册 (实际的)

31

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Florida
      • Miami、Florida、美国、33136
        • University of Miami School of Medicine

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

25年 至 75年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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:
  • Qaw
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:
  • Qaw

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

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年4月1日

初级完成 (实际的)

2015年6月1日

研究完成 (实际的)

2015年12月1日

研究注册日期

首次提交

2014年3月25日

首先提交符合 QC 标准的

2014年5月16日

首次发布 (估计)

2014年5月19日

研究记录更新

最后更新发布 (估计)

2016年12月16日

上次提交的符合 QC 标准的更新

2016年10月25日

最后验证

2016年10月1日

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

3
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