Assessment of Mold Exposure in Asthmatic Children Follow-up in Nord and Pas-De-Calais Departments, France, and Impact on Asthma Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 451
- 试验地点
- 10
- 主要终点
- Asthma control according to GINA guidelines
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Questionnaire of Mold / moisture exposure (Other)
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.
干预措施: Questionnaire of Mold / moisture exposure (Other)
结局指标
主要结局
Asthma control according to GINA guidelines
时间窗: At the time of inclusion
The Global Initiative for Asthma (GINA)guidelines: Well controlled Partly controlled Uncontrolled
次要结局
- Acute asthma events in the past 12 months(At the time of inclusion)
- Inhaled corticosteroid doses in µg/day of fluticasone(At the time of inclusion)
- Exposure to indoor allergens: declarative exposure to house dust mite (carpet, mattress)(At the time of inclusion)
- Asthma control according to Asthma Control Test (ACT) score in children aged 12 years and older: Controlled if ACT ≥ 20(At the time of inclusion)
- Exposure to indoor allergens: declarative exposure to animal danders(At the time of inclusion)
- Asthma control according to pACT score in children aged 1 to 11 years old: Controlled if ACT ≥ 20(At the time of inclusion)
- Exposure to other indoor pollutants: cigarette smoke (declarative smoking by at least one of the parents)(At the time of inclusion)
- 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(At the time of inclusion)