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Exercise in Air Pollution and Lung Health in Asthmatics

28 september 2021 bijgewerkt door: Michael Koehle, University of British Columbia

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

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Verwacht)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z1
        • University of British Columbia, Environmental Physiology Laboratory

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

19 jaar tot 40 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Resting in diesel exhaust following salbutamol inhalation
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.
Ander: Rest (Sitting on chair)
Study participants will sit on a chair for 60min. This is to simulate physical resting condition.
Geneesmiddel: Salbutamol inhalation
Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.
Ander: Diesel Exhaust Exposure
Participants will be exposed to PM2.5 of 300 μg/m3
Placebo-vergelijker: Resting in diesel exhaust following placebo inhalation
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.
Ander: Rest (Sitting on chair)
Study participants will sit on a chair for 60min. This is to simulate physical resting condition.
Ander: Diesel Exhaust Exposure
Participants will be exposed to PM2.5 of 300 μg/m3
Geneesmiddel: Placebo inhalation
Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber
Actieve vergelijker: Cycling in diesel exhaust following salbutamol inhalation
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.
Geneesmiddel: Salbutamol inhalation
Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.
Ander: Diesel Exhaust Exposure
Participants will be exposed to PM2.5 of 300 μg/m3
Ander: 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.
Placebo-vergelijker: Cycling in diesel exhaust following placebo inhalation
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
Ander: Diesel Exhaust Exposure
Participants will be exposed to PM2.5 of 300 μg/m3
Geneesmiddel: Placebo inhalation
Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber
Ander: 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.
Sham-vergelijker: Resting in filtered air following salbutamol inhalation
Participants will be sitting while being exposed to filtered air for a total of 1hour following the inhalation of 400ug of salbutamol.
Ander: Rest (Sitting on chair)
Study participants will sit on a chair for 60min. This is to simulate physical resting condition.
Ander: Filtered air
Participants will be breathing filtered air
Placebo-vergelijker: Resting in filtered air following placebo inhalation
Participants will be sitting while being exposed to filtered air for a total of 1hour following the inhalation of a placebo.
Ander: Rest (Sitting on chair)
Study participants will sit on a chair for 60min. This is to simulate physical resting condition.
Ander: Filtered air
Participants will be breathing filtered air
Sham-vergelijker: Cycling in filtered air following salbutamol inhalation
Participants will be cycling while being exposed to filtered air for a total of 1 hr following the inhalation of 400ug of salbutamol.
Geneesmiddel: Salbutamol inhalation
Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.
Ander: 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.
Ander: Filtered air
Participants will be breathing filtered air
Placebo-vergelijker: Cycling in filtered air following placebo inhalation
Participants will be cycling while being exposed to filtered air for a total of 1 hr following the inhalation of a placebo
Geneesmiddel: Placebo inhalation
Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber
Ander: 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.
Ander: Filtered air
Participants will be breathing filtered air

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Change in rating of perceived exertion for breathing, dyspnea
Tijdsspanne: 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.
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.

Secundaire uitkomstmaten

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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in spirometry (FEV1 and FVC) between filtered air and polluted air
Tijdsspanne: Spirometry will be assessed at baseline and 45min after the start of the exercise bout.
Spirometry will be assessed at baseline and 45min after the start of the exercise bout.
Change in cognitive function
Tijdsspanne: Cognitive function will be assessed at baseline (prior to entering the air pollution chamber) and 45 min after the start of the exercise intervention.
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.
Retinal Imaging
Tijdsspanne: The retina will be imaged at baseline (prior to entering the air pollution chamber) and 20 min after the completion of the exercise intervention.
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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of British Columbia

Medewerkers

Natural Sciences and Engineering Research Council, Canada
Canadian Academy of Sport and Exercise Medicine (CASEM)
Fraser Basin Council

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2015

Primaire voltooiing (Werkelijk)

1 augustus 2016

Studie voltooiing (Werkelijk)

1 mei 2021

Studieregistratiedata

Eerst ingediend

16 september 2014

Eerst ingediend dat voldeed aan de QC-criteria

29 september 2014

Eerst geplaatst (Schatting)

30 september 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 september 2021

Laatste update ingediend die voldeed aan QC-criteria

28 september 2021

Laatst geverifieerd

1 september 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • H13-01079

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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