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Mold Exposure and Impact on Asthma Control in French Asthmatic Children (CHAMPIASTHMA)

28. marts 2022 opdateret af: University Hospital, Lille

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

451

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Armentières, Frankrig
        • Ch Armentieres
      • Boulogne Sur Mer, Frankrig, 62321
        • Ch Boulogne-Sur-Me
      • Calais, Frankrig
        • Ch Calais
      • Dunkerque, Frankrig, 59385
        • CH Dunkerque
      • Lens, Frankrig
        • Centre Hospitalier de LENS
      • Lille, Frankrig, 59037
        • Hop Jeanne de Flandre Chu Lille
      • Lille, Frankrig
        • Centre Hospitalier St Vincent
      • Roubaix, Frankrig
        • Centre Hospitalier de Roubaix
      • Seclin, Frankrig
        • Centre Hospitalier de Seclin
      • Valenciennes, Frankrig
        • Centre Hospitalier,

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Children follow-up by a specialized asthma pediatrician in secondary (general hospital) and tertiary care (Lille university hospital) centers.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Andet: Questionnaire of Mold / moisture exposure

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:

  • Presence of visible mold
  • Impression of dampness
  • Apparent dampness
  • Existence of recent water damage in the last year
  • Presence of a moldy odor
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.
Andet: Questionnaire of Mold / moisture exposure

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:

  • Presence of visible mold
  • Impression of dampness
  • Apparent dampness
  • Existence of recent water damage in the last year
  • Presence of a moldy odor

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Asthma control according to GINA guidelines
Tidsramme: At the time of inclusion

The Global Initiative for Asthma (GINA)guidelines:

Well controlled Partly controlled Uncontrolled
At the time of inclusion

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Asthma control according to Asthma Control Test (ACT) score in children aged 12 years and older: Controlled if ACT ≥ 20
Tidsramme: 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
Asthma control according to pACT score in children aged 1 to 11 years old: Controlled if ACT ≥ 20
Tidsramme: At the time of inclusion
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
Tidsramme: At the time of inclusion
At the time of inclusion
Inhaled corticosteroid doses in µg/day of fluticasone
Tidsramme: At the time of inclusion
At the time of inclusion
Acute asthma events in the past 12 months
Tidsramme: At the time of inclusion
Acute asthma events: emergency room visits, hospitalization, general corticosteroid course
At the time of inclusion
Exposure to other indoor pollutants: cigarette smoke (declarative smoking by at least one of the parents)
Tidsramme: At the time of inclusion
At the time of inclusion
Exposure to indoor allergens: declarative exposure to animal danders
Tidsramme: At the time of inclusion
At the time of inclusion
Exposure to indoor allergens: declarative exposure to house dust mite (carpet, mattress)
Tidsramme: At the time of inclusion
At the time of inclusion

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Lille

Efterforskere

  • Ledende efterforsker: Antoine DESCHILDRE, MD,PhD, University Hospital, Lille

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. juni 2020

Primær færdiggørelse (Faktiske)

20. august 2021

Studieafslutning (Faktiske)

20. august 2021

Datoer for studieregistrering

Først indsendt

2. juni 2021

Først indsendt, der opfyldte QC-kriterier

2. juni 2021

Først opslået (Faktiske)

8. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2019_49
  • 2019-A03310-57 (Anden identifikator: ID-RCB number,ANSM)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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