Mold Exposure and Impact on Asthma Control in French Asthmatic Children (CHAMPIASTHMA)
Assessment of Mold Exposure in Asthmatic Children Follow-up in Nord and Pas-De-Calais Departments, France, and Impact on Asthma Control
Observational, multicenter, study conducted in 12 hospitals in the Nord and Pas-De-Calais departments. The aim of this study is to describe the relationship between reported exposure to molds and asthma control in a pediatric population.
Each patient followed by a specialized asthma pediatrician in one of the study center will be proposed to participate in the study.
Children aged 1 to < 18 years, with asthma diagnosis, based on the assessment of a specialized physician after a follow-up of at least 6 months Inclusion, non-inclusion and exclusion criteria will be verified by the investigators. The questionnaires will be completed during the consultation, collected by the physician in charge of the consultation and sent to the principal investigator for data entry.
Inclusion will take place over a period of 12 consecutive months from the date of obtaining regulatory approval.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
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Armentières、フランス
- Ch Armentieres
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Boulogne Sur Mer、フランス、62321
- Ch Boulogne-Sur-Me
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Calais、フランス
- Ch Calais
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Dunkerque、フランス、59385
- CH Dunkerque
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Lens、フランス
- Centre Hospitalier de LENS
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Lille、フランス、59037
- Hop Jeanne de Flandre Chu Lille
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Lille、フランス
- Centre Hospitalier St Vincent
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Roubaix、フランス
- Centre Hospitalier de Roubaix
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Seclin、フランス
- Centre Hospitalier de Seclin
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Valenciennes、フランス
- Centre Hospitalier,
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Children aged 1 to < 18 years, with asthma diagnosis, based on the assessment of a specialized physician after a follow-up of at least 6 months, Follow-up in one of the study center in Nord and Pas de Calais departments (Lille, Lens, Tourcoing, Valenciennes, Arras, Roubaix, Seclin, Armentières, Calais, Boulogne/mer, Dunkerque, GHICL-Saint Vincent) over an inclusion period of 12 months
Exclusion Criteria:
- Children living ≤ 50% of the weekly time in their primary home (e.g., shared custody)
- Children whose living arrangement characteristics are difficult to analyze (e.g., child accompanied by grandparents or by the parent without primary custody)
- Children whose residence has recently changed, making it impossible to assess the impact of the living arrangement over the past year
- Children living outside of the Nord and Pas-de-Calais departments
- Children whose parents are unable to complete the questionnaire
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 |
介入・治療 |
|---|---|
|
Asthma patients unexposed to mold / moisture
No mold / moisture exposure is defined by a negative response to all of the 5 following questions, asked in the form of a parent-completed declarative questionnaire regarding the child's primary living home.
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Mold / moisture exposure is assessed by the 5 following questions, whose positive response has been associated with the actual presence of mold in the household (according to data from the literature data), asked in the form of a parent-completed declarative questionnaire regarding the child's primary living home:
|
|
Asthma patients exposed to mold / moisture
Mold / moisture exposure is defined by a positive response to at least one of the 5 following questions, asked in the form of a parent-completed declarative questionnaire regarding the child's primary living home.
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Mold / moisture exposure is assessed by the 5 following questions, whose positive response has been associated with the actual presence of mold in the household (according to data from the literature data), asked in the form of a parent-completed declarative questionnaire regarding the child's primary living home:
|
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 |
|---|---|---|
|
Asthma control according to GINA guidelines
時間枠：At the time of inclusion
|
The Global Initiative for Asthma (GINA)guidelines: Well controlled Partly controlled Uncontrolled |
At the time of inclusion
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Asthma control according to Asthma Control Test (ACT) score in children aged 12 years and older: Controlled if ACT ≥ 20
時間枠：At the time of inclusion
|
Asthma Control Test: Each question is assigned a score between 1 and 5 (the score for the first answer proposal is 1, the second is 2, and so on).
The score of the 5 questions is added up to a total score that can vary between 5 and 25.
The higher the total score, the better the asthma is controlled.
|
At the time of inclusion
|
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Asthma control according to pACT score in children aged 1 to 11 years old: Controlled if ACT ≥ 20
時間枠：At the time of inclusion
|
At the time of inclusion
|
|
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Asthma treatment step according to GINA guidelines: Step 1 to step 4 in children aged < 6 years Step 1 to step 5 in children aged ≥ 6 years
時間枠：At the time of inclusion
|
At the time of inclusion
|
|
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Inhaled corticosteroid doses in µg/day of fluticasone
時間枠：At the time of inclusion
|
At the time of inclusion
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Acute asthma events in the past 12 months
時間枠：At the time of inclusion
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Acute asthma events: emergency room visits, hospitalization, general corticosteroid course
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At the time of inclusion
|
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Exposure to other indoor pollutants: cigarette smoke (declarative smoking by at least one of the parents)
時間枠：At the time of inclusion
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At the time of inclusion
|
|
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Exposure to indoor allergens: declarative exposure to animal danders
時間枠：At the time of inclusion
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At the time of inclusion
|
|
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Exposure to indoor allergens: declarative exposure to house dust mite (carpet, mattress)
時間枠：At the time of inclusion
|
At the time of inclusion
|
協力者と研究者
捜査官
- 主任研究者：Antoine DESCHILDRE, MD,PhD、University Hospital, Lille
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。
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