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临床试验/NCT02252302
NCT02252302已完成不适用

The Effects of Inhaled Beta-2-Agonists and Air Pollution on Lung Function and Athletic Capacity

University of British Columbia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年5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
20
试验地点
1
主要终点
Change in rating of perceived exertion for breathing, dyspnea

研究概览

简要总结

When exposed to air pollution, the asthma symptoms are aggravated and lung function is impaired. Due to high breathing rates and volumes, physically active individuals are at particular risk of lung health impairment due to the high breathing rates and volumes. Greater doses of air pollutants reach deeper areas in the lungs where they can trigger asthma-symptoms. When treating these symptoms with inhaled beta-2-agonists the airways widen even more, allowing the air pollutants to reach even deeper areas of the lung. With this study the investigators investigate how inhaled beta-2-agonists affect athletic capacity and lung health in physically active asthmatics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • mild-moderate asthmatics with controlled treatment (definition of "mild": percent fall index at eucapnic voluntary hyperpnea (EVH) test on screening day between 10-15%; "moderate": percent fall index at EVH test on screening day between 15 - 20%).
  • men and non-pregnant women

排除标准

  • any history of uncontrolled respiratory or cardiac disease
  • pregnancy
  • allergic reactions to lidocaine and salbutamol
  • any recent infections or orthopaedic nasal issues/injuries that may interfere with the insertion of the catheter needed to assess expiratory flow limitation or work of breathing
  • claustrophobia in small rooms, comparable to the air pollution chamber used for this study.
  • English as a second language (ESL) - participants who are not able to understand the risk that may be associated with the participation in this study due to language difficulties after following the University of British Clinical Research Ethics Board Guidance Notes 13.2.
  • (ESL participants will be given a consent form in the most appropriate language or an appropriate translator will be present during the initial consent process).

研究组 & 干预措施

Resting in diesel exhaust following salbutamol inhalation

Active Comparator

Participants will be sitting in an air pollution chamber while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1hour following the inhalation of 400ug of salbutamol.

干预措施: Rest (Sitting on chair) (Other)

Resting in diesel exhaust following salbutamol inhalation

Active Comparator

Participants will be sitting in an air pollution chamber while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1hour following the inhalation of 400ug of salbutamol.

干预措施: Salbutamol inhalation (Drug)

Resting in diesel exhaust following salbutamol inhalation

Active Comparator

Participants will be sitting in an air pollution chamber while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1hour following the inhalation of 400ug of salbutamol.

干预措施: Diesel Exhaust Exposure (Other)

Resting in diesel exhaust following placebo inhalation

Placebo Comparator

Participants will be sitting in an air pollution chamber while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1hour following the inhalation of a placebo.

干预措施: Rest (Sitting on chair) (Other)

Resting in diesel exhaust following placebo inhalation

Placebo Comparator

Participants will be sitting in an air pollution chamber while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1hour following the inhalation of a placebo.

干预措施: Placebo inhalation (Drug)

Resting in diesel exhaust following placebo inhalation

Placebo Comparator

Participants will be sitting in an air pollution chamber while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1hour following the inhalation of a placebo.

干预措施: Diesel Exhaust Exposure (Other)

Cycling in diesel exhaust following salbutamol inhalation

Active Comparator

Participants will be cycling while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1 hr following the inhalation of 400ug of salbutamol.

干预措施: Cycling exercise (Other)

Cycling in diesel exhaust following salbutamol inhalation

Active Comparator

Participants will be cycling while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1 hr following the inhalation of 400ug of salbutamol.

干预措施: Salbutamol inhalation (Drug)

Cycling in diesel exhaust following salbutamol inhalation

Active Comparator

Participants will be cycling while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1 hr following the inhalation of 400ug of salbutamol.

干预措施: Diesel Exhaust Exposure (Other)

Cycling in diesel exhaust following placebo inhalation

Placebo Comparator

Participants will be cycling while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1 hr following the inhalation of a placebo

干预措施: Cycling exercise (Other)

Cycling in diesel exhaust following placebo inhalation

Placebo Comparator

Participants will be cycling while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1 hr following the inhalation of a placebo

干预措施: Placebo inhalation (Drug)

Cycling in diesel exhaust following placebo inhalation

Placebo Comparator

Participants will be cycling while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1 hr following the inhalation of a placebo

干预措施: Diesel Exhaust Exposure (Other)

Resting in filtered air following salbutamol inhalation

Sham Comparator

Participants will be sitting while being exposed to filtered air for a total of 1hour following the inhalation of 400ug of salbutamol.

干预措施: Rest (Sitting on chair) (Other)

Resting in filtered air following salbutamol inhalation

Sham Comparator

Participants will be sitting while being exposed to filtered air for a total of 1hour following the inhalation of 400ug of salbutamol.

干预措施: Filtered air (Other)

Resting in filtered air following placebo inhalation

Placebo Comparator

Participants will be sitting while being exposed to filtered air for a total of 1hour following the inhalation of a placebo.

干预措施: Rest (Sitting on chair) (Other)

Resting in filtered air following placebo inhalation

Placebo Comparator

Participants will be sitting while being exposed to filtered air for a total of 1hour following the inhalation of a placebo.

干预措施: Filtered air (Other)

Cycling in filtered air following salbutamol inhalation

Sham Comparator

Participants will be cycling while being exposed to filtered air for a total of 1 hr following the inhalation of 400ug of salbutamol.

干预措施: Cycling exercise (Other)

Cycling in filtered air following salbutamol inhalation

Sham Comparator

Participants will be cycling while being exposed to filtered air for a total of 1 hr following the inhalation of 400ug of salbutamol.

干预措施: Salbutamol inhalation (Drug)

Cycling in filtered air following salbutamol inhalation

Sham Comparator

Participants will be cycling while being exposed to filtered air for a total of 1 hr following the inhalation of 400ug of salbutamol.

干预措施: Filtered air (Other)

Cycling in filtered air following placebo inhalation

Placebo Comparator

Participants will be cycling while being exposed to filtered air for a total of 1 hr following the inhalation of a placebo

干预措施: Cycling exercise (Other)

Cycling in filtered air following placebo inhalation

Placebo Comparator

Participants will be cycling while being exposed to filtered air for a total of 1 hr following the inhalation of a placebo

干预措施: Placebo inhalation (Drug)

Cycling in filtered air following placebo inhalation

Placebo Comparator

Participants will be cycling while being exposed to filtered air for a total of 1 hr following the inhalation of a placebo

干预措施: Filtered air (Other)

结局指标

主要结局

Change in rating of perceived exertion for breathing, dyspnea

时间窗: Difference in perceived dyspnea between salbutamol and placebo exposure as well as polluted air and filtered air. Dyspnea ratings will be collected every 2.5min for a duration of 45min during the exercise test.

次要结局

  • Change in work of breathing (WOB) between filtered air and polluted air(work of breathing will be assessed every 2.5min for a time period of 45min during the exercise bout)

研究者

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

Michael Koehle

Principal Investigaor

University of British Columbia

研究点 (1)

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