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Predictive Factors for a Positive Exercise Bronchial Hyperresponsiveness Test (PredEIB)

11. august 2026 opdateret af: Dr. Iulia IOAN, Central Hospital, Nancy, France
Exertional dyspnea has a significant impact on a child's daily life. Current guidelines recommend performing an exercise challenge test to confirm or rule out exercise-induced bronchoconstriction (EIB). But the 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

100

Kontakter og lokationer

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

Studiesteder

  • Frankrig
      • Nancy, Frankrig
        • CHRU de Nancy

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

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Children referred by a pediatric pulmonologist to the pediatric respiratory function testing department in 2024 and 2025 for an exercise test. Children with asthma diagnosed by a physician will be excluded.

Beskrivelse

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

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
Children without exercise-induced bronchocontriction
Children with a reduction in FEV1 < 10% from baseline after the exercise challenge test
Children with exercise-induced bronchocontriction
Children with a reduction in FEV1 ≥ 10% from baseline after the exercise challenge test

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Presence of wheezing at exercise
Tidsramme: The test duration (3 hours)
Presence of reported exercise-induced wheezing, as documented in the subject's electronic medical record (yes/no; binary variable).
The test duration (3 hours)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Presence of reported dyspnea at exercise
Tidsramme: 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
Presence of reported cough at exercise
Tidsramme: The test duration 3 hours
Presence of reported exercise-induced cough, as documented in the subject's electronic medical record (yes/no; binary variable).
The test duration 3 hours
Presence of reported chest tightness at exercise
Tidsramme: 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).
The test duration 3 hours
Functional parameters - FEV1 z-score at baseline
Tidsramme: 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
Reported atopy
Tidsramme: The test duration 3 hours
Presence of asthma or atopy history, as documented in the subject's electronic medical record (yes/no; binary variable).
The test duration 3 hours
Reported clinical history
Tidsramme: 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)
The test duration 3 hours
Functional parameters - FEV1/FVC z-score at baseline
Tidsramme: 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

Samarbejdspartnere og efterforskere

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

Sponsor

Central Hospital, Nancy, France

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)

30. maj 2024

Primær færdiggørelse (Faktiske)

1. juni 2026

Studieafslutning (Faktiske)

8. juni 2026

Datoer for studieregistrering

Først indsendt

27. juli 2026

Først indsendt, der opfyldte QC-kriterier

11. august 2026

Først opslået (Faktiske)

14. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026PI119

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

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