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临床试验/NCT05087693
NCT05087693已完成4 期

Examining the Effect of Salbutamol Use in Asthma and/or Exercise Induced Bronchoconstriction Whilst Exercising in Ozone Air Pollution

University of British Columbia1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
18
试验地点
1
主要终点
Measured Before and 30 Minutes After Exercise in Each 1 Day Condition

研究概览

简要总结

Salbutamol use is increased in areas with high levels of ozone pollution and the potential consequences of this are not well known. The purpose of this study is to examine the effect of salbutamol on lung function and inflammation in people with asthma and/or EIB exercising in ozone air pollution. To examine this, we are planning a randomized cross over trial where people with asthma and/or EIB complete sub maximal exercise in four conditions on four separate days. The four condition are: ozone + salbutamol, filtered air + salbutamol, ozone + placebo medication, and filtered air + placebo medication.

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
Double (Participant, Investigator)

盲法说明

Drug condition (placebo or salbutamol) will be double blinded Air quality condition (ozone or filtered air) will be single blinded

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Have asthma and/or EIB
  • Able to perform maximal exercise
  • Able to communicate sufficiently using the English language

排除标准

  • Allergic to salbutamol (also known as Ventolin)
  • Pregnant or potentially pregnant
  • Have a history of smoking
  • Had an upper respiratory tract infection within the last 4 weeks
  • Have a chronic respiratory disease other than asthma or EIB

研究组 & 干预措施

Exercising in ozone following salbutamol inhalation

Experimental

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling 200ug of salbutamol.

干预措施: Salbutamol (Drug)

Exercising in ozone following salbutamol inhalation

Experimental

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling 200ug of salbutamol.

干预措施: Ozone (Other)

Exercising in ozone following salbutamol inhalation

Experimental

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling 200ug of salbutamol.

干预措施: Exercise (Other)

Exercising in filtered air following salbutamol inhalation

Active Comparator

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered air after inhaling 200ug of salbutamol.

干预措施: Salbutamol (Drug)

Exercising in filtered air following salbutamol inhalation

Active Comparator

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered air after inhaling 200ug of salbutamol.

干预措施: Filtered Air (Other)

Exercising in filtered air following salbutamol inhalation

Active Comparator

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered air after inhaling 200ug of salbutamol.

干预措施: Exercise (Other)

Exercising in ozone following placebo inhalation

Placebo Comparator

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling placebo medication.

干预措施: Placebo medication (Drug)

Exercising in ozone following placebo inhalation

Placebo Comparator

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling placebo medication.

干预措施: Ozone (Other)

Exercising in ozone following placebo inhalation

Placebo Comparator

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling placebo medication.

干预措施: Exercise (Other)

Exercising in filtered air following placebo inhalation

Placebo Comparator

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication.

干预措施: Placebo medication (Drug)

Exercising in filtered air following placebo inhalation

Placebo Comparator

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication.

干预措施: Filtered Air (Other)

Exercising in filtered air following placebo inhalation

Placebo Comparator

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication.

干预措施: Exercise (Other)

结局指标

主要结局

Measured Before and 30 Minutes After Exercise in Each 1 Day Condition

时间窗: Measured before and 30 minutes after exercise in each 1 day condition

Measure of pulmonary function

Change in FVC From Baseline to 30 Minutes After Exercise

时间窗: Measured before and 30 minutes after exercise in each 1 day condition

Measure of pulmonary function

次要结局

未报告次要终点

研究者

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

Michael Koehle

Professor

University of British Columbia

研究点 (1)

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