Predictive Factors for a Positive Exercise Bronchial Hyperresponsiveness Test (PredEIB)
調査の概要
状態
条件
詳細な説明
Exertional dyspnea is a frequent reason for consultation in pediatric pulmonology. The perception of dyspnea varies from one child to another, with some children over- or under- perceiving its intensity. Dyspnea has a significant impact on a child's daily life and quality of life and, in pediatrics, always raises the suspicion of exercise-induced asthma. Current guidelines recommend performing an exercise challenge test to confirm or rule out exercise-induced bronchoconstriction (EIB) if it is suspected. However, this test is not widely available. The objective of this research is to identify the clinical and respiratory functional factors predictive of a positive exercise challenge test in children.
The potential benefit of this study is to better identify individuals who would benefit from undergoing an exercise challenge test.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Nancy、フランス
- CHRU de Nancy
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Children aged 5 to 18 years who performed an exercise challenge test during the years 2024 and 2025
Exclusion Criteria:
- Children with doctor-diagnosed asthma
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
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Children without exercise-induced bronchocontriction
Children with a reduction in FEV1 < 10% from baseline after the exercise challenge test
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Children with exercise-induced bronchocontriction
Children with a reduction in FEV1 ≥ 10% from baseline after the exercise challenge test
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Presence of wheezing at exercise
時間枠：The test duration (3 hours)
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Presence of reported exercise-induced wheezing, as documented in the subject's electronic medical record (yes/no; binary variable).
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The test duration (3 hours)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Presence of reported dyspnea at exercise
時間枠：The test duration 3 hours
|
Presence of reported exercise-induced dyspnea, as documented in the subject's electronic medical record (yes/no; binary variable).
|
The test duration 3 hours
|
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Presence of reported cough at exercise
時間枠：The test duration 3 hours
|
Presence of reported exercise-induced cough, as documented in the subject's electronic medical record (yes/no; binary variable).
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The test duration 3 hours
|
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Presence of reported chest tightness at exercise
時間枠：The test duration 3 hours
|
Presence of reported exercise-induced chest tightness, as documented in the subject's electronic medical record (yes/no; binary variable).
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The test duration 3 hours
|
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Functional parameters - FEV1 z-score at baseline
時間枠：The test duration 3 hours
|
Spirometric parameters measured before exercise testing - FEV1 z-score (forced expiratory volume in 1 sec) from spirometry performed before exercise testing and documented in the electronic folder of the patient
|
The test duration 3 hours
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Reported atopy
時間枠：The test duration 3 hours
|
Presence of asthma or atopy history, as documented in the subject's electronic medical record (yes/no; binary variable).
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The test duration 3 hours
|
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Reported clinical history
時間枠：The test duration 3 hours
|
Reported early respiratory history (≥ 3 wheezing episodes before the age of 3 years; at least one episode of pneumonia or atelectasis), from the clinical history recorded in the electronic folder of the patients (yes/no, binary variable)
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The test duration 3 hours
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Functional parameters - FEV1/FVC z-score at baseline
時間枠：The test duration 3 hours
|
Spirometric parameters measured before exercise testing - FEV1/FVC z-score (FVC = forced vital capacity) from spirometry performed before exercise testing and documented in the electronic folder of the patient
|
The test duration 3 hours
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。