Exercise in Air Pollution and Lung Health in Asthmatics
2021年9月28日 更新者：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.
調査の概要
状態
完了
研究の種類
介入
入学 (予想される)
20
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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British Columbia
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Vancouver、British Columbia、カナダ、V6T 1Z1
- University of British Columbia, Environmental Physiology Laboratory
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
19年～40年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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
|
|
プラセボコンパレーター：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
|
|
アクティブコンパレータ：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.
|
|
プラセボコンパレーター：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.
|
|
偽コンパレータ：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
|
|
プラセボコンパレーター：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
|
|
偽コンパレータ：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
|
|
プラセボコンパレーター：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in rating of perceived exertion for breathing, dyspnea
時間枠：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.
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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.
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in work of breathing (WOB) between filtered air and polluted air
時間枠：work of breathing will be assessed every 2.5min for a time period of 45min during the exercise bout
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work of breathing will be assessed every 2.5min for a time period of 45min during the exercise bout
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in spirometry (FEV1 and FVC) between filtered air and polluted air
時間枠：Spirometry will be assessed at baseline and 45min after the start of the exercise bout.
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Spirometry will be assessed at baseline and 45min after the start of the exercise bout.
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Change in cognitive function
時間枠：Cognitive function will be assessed at baseline (prior to entering the air pollution chamber) and 45 min after the start of the exercise intervention.
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cognitive function will be assessed using the NIH toolbox tests and the brain derived neurotrophic factor (BDNF) blood serum measurements
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Cognitive function will be assessed at baseline (prior to entering the air pollution chamber) and 45 min after the start of the exercise intervention.
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Retinal Imaging
時間枠：The retina will be imaged at baseline (prior to entering the air pollution chamber) and 20 min after the completion of the exercise intervention.
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The blood vessels in the eye will be imaged using a camera.
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The retina will be imaged at baseline (prior to entering the air pollution chamber) and 20 min after the completion of the exercise intervention.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年5月1日
一次修了 (実際)
2016年8月1日
研究の完了 (実際)
2021年5月1日
試験登録日
最初に提出
2014年9月16日
QC基準を満たした最初の提出物
2014年9月29日
最初の投稿 (見積もり)
2014年9月30日
学習記録の更新
投稿された最後の更新 (実際)
2021年9月30日
QC基準を満たした最後の更新が送信されました
2021年9月28日
最終確認日
2021年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- H13-01079
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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