Exercise in Air Pollution and Lung Health in Asthmatics

Air Pollution Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252302
• Other study ID #: H13-01079
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: May 2021

Study information

• Verified date: September 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2021
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 13.2.1. (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).

Related Conditions & MeSH terms

• Air Pollution
• Exercise-induced Bronchoconstriction

Intervention

Other:
• Rest (Sitting on chair)
Study participants will sit on a chair for 60min. This is to simulate physical resting condition.
• Cycling exercise
Study participants will exercise on a cycle ergometer for 45min. Participants will start their 30-min long constant workload exercise test test 60-min after the drug intervention. The exercise test will be set to a resistance of 50% of the maximal wattage that was reached on the graded exercise test on the screening day. The cycling exercise intervention will follow the rest-intervention.

Drug:
• Salbutamol inhalation
Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.
• Placebo inhalation
Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber

Other:
• Diesel Exhaust Exposure
Participants will be exposed to PM2.5 of 300 µg/m3
• Filtered air
Participants will be breathing filtered air

Locations

Country	Name	City	State
Canada	University of British Columbia, Environmental Physiology Laboratory	Vancouver	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Academy of Sport and Exercise Medicine (CASEM), Fraser Basin Council, Natural Sciences and Engineering Research Council, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in spirometry (FEV1 and FVC) between filtered air and polluted air		Spirometry will be assessed at baseline and 45min after the start of the exercise bout.
Other	Change in cognitive function	cognitive function will be assessed using the NIH toolbox tests and the brain derived neurotrophic factor (BDNF) blood serum measurements	Cognitive function will be assessed at baseline (prior to entering the air pollution chamber) and 45 min after the start of the exercise intervention.
Other	Retinal Imaging	The blood vessels in the eye will be imaged using a camera.	The retina will be imaged at baseline (prior to entering the air pollution chamber) and 20 min after the completion of the exercise intervention.
Primary	Change in rating of perceived exertion for breathing, dyspnea		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.
Secondary	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