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.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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-
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Armentières, 프랑스
- Ch Armentieres
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Boulogne Sur Mer, 프랑스, 62321
- Ch Boulogne-Sur-Me
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Calais, 프랑스
- Ch Calais
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Dunkerque, 프랑스, 59385
- CH Dunkerque
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Lens, 프랑스
- Centre Hospitalier de LENS
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Lille, 프랑스, 59037
- Hop Jeanne de Flandre Chu Lille
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Lille, 프랑스
- Centre Hospitalier St Vincent
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Roubaix, 프랑스
- Centre Hospitalier de Roubaix
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Seclin, 프랑스
- Centre Hospitalier de Seclin
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Valenciennes, 프랑스
- Centre Hospitalier,
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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:
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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:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Asthma control according to GINA guidelines
기간: At the time of inclusion
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The Global Initiative for Asthma (GINA)guidelines: Well controlled Partly controlled Uncontrolled |
At the time of inclusion
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Asthma control according to Asthma Control Test (ACT) score in children aged 12 years and older: Controlled if ACT ≥ 20
기간: At the time of inclusion
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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.
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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
기간: At the time of inclusion
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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
기간: At the time of inclusion
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At the time of inclusion
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Inhaled corticosteroid doses in µg/day of fluticasone
기간: At the time of inclusion
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At the time of inclusion
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Acute asthma events in the past 12 months
기간: 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)
기간: 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
기간: 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)
기간: At the time of inclusion
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At the time of inclusion
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공동 작업자 및 조사자
수사관
- 수석 연구원: Antoine DESCHILDRE, MD,PhD, University Hospital, Lille
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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