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Exercise in Air Pollution and Lung Health in Asthmatics

28 settembre 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Anticipato)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 19 anni a 40 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: Rest (Sitting on chair)
Study participants will sit on a chair for 60min. This is to simulate physical resting condition.
Droga: Salbutamol inhalation
Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.
Altro: Diesel Exhaust Exposure
Participants will be exposed to PM2.5 of 300 μg/m3
Comparatore placebo: 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.
Altro: Rest (Sitting on chair)
Study participants will sit on a chair for 60min. This is to simulate physical resting condition.
Altro: Diesel Exhaust Exposure
Participants will be exposed to PM2.5 of 300 μg/m3
Droga: Placebo inhalation
Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber
Comparatore attivo: 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.
Droga: Salbutamol inhalation
Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.
Altro: Diesel Exhaust Exposure
Participants will be exposed to PM2.5 of 300 μg/m3
Altro: 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.
Comparatore placebo: 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
Altro: Diesel Exhaust Exposure
Participants will be exposed to PM2.5 of 300 μg/m3
Droga: Placebo inhalation
Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber
Altro: 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.
Comparatore fittizio: 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.
Altro: Rest (Sitting on chair)
Study participants will sit on a chair for 60min. This is to simulate physical resting condition.
Altro: Filtered air
Participants will be breathing filtered air
Comparatore placebo: 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.
Altro: Rest (Sitting on chair)
Study participants will sit on a chair for 60min. This is to simulate physical resting condition.
Altro: Filtered air
Participants will be breathing filtered air
Comparatore fittizio: 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.
Droga: Salbutamol inhalation
Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.
Altro: 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.
Altro: Filtered air
Participants will be breathing filtered air
Comparatore placebo: 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
Droga: Placebo inhalation
Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber
Altro: 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.
Altro: Filtered air
Participants will be breathing filtered air

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Change in rating of perceived exertion for breathing, dyspnea
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Change in work of breathing (WOB) between filtered air and polluted air
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in spirometry (FEV1 and FVC) between filtered air and polluted air
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of British Columbia

Collaboratori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2015

Completamento primario (Effettivo)

1 agosto 2016

Completamento dello studio (Effettivo)

1 maggio 2021

Date di iscrizione allo studio

Primo inviato

16 settembre 2014

Primo inviato che soddisfa i criteri di controllo qualità

29 settembre 2014

Primo Inserito (Stima)

30 settembre 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 settembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 settembre 2021

Ultimo verificato

1 settembre 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • H13-01079

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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