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Exercise in Air Pollution and Lung Health in Asthmatics

28. September 2021 aktualisiert von: 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.

Studienübersicht

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

19 Jahre bis 40 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Study participants will sit on a chair for 60min. This is to simulate physical resting condition.
Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.
Participants will be exposed to PM2.5 of 300 μg/m3
Placebo-Komparator: 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.
Study participants will sit on a chair for 60min. This is to simulate physical resting condition.
Participants will be exposed to PM2.5 of 300 μg/m3
Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber
Aktiver Komparator: 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.
Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.
Participants will be exposed to PM2.5 of 300 μg/m3
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-Komparator: 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
Participants will be exposed to PM2.5 of 300 μg/m3
Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber
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.
Schein-Komparator: 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.
Study participants will sit on a chair for 60min. This is to simulate physical resting condition.
Participants will be breathing filtered air
Placebo-Komparator: 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.
Study participants will sit on a chair for 60min. This is to simulate physical resting condition.
Participants will be breathing filtered air
Schein-Komparator: 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.
Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.
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.
Participants will be breathing filtered air
Placebo-Komparator: 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
Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber
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.
Participants will be breathing filtered air

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Change in rating of perceived exertion for breathing, dyspnea
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Change in work of breathing (WOB) between filtered air and polluted air
Zeitfenster: 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 Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in spirometry (FEV1 and FVC) between filtered air and polluted air
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Mai 2015

Primärer Abschluss (Tatsächlich)

1. August 2016

Studienabschluss (Tatsächlich)

1. Mai 2021

Studienanmeldedaten

Zuerst eingereicht

16. September 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. September 2014

Zuerst gepostet (Schätzen)

30. September 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. September 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. September 2021

Zuletzt verifiziert

1. September 2021

Mehr Informationen

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