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

11. august 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Astma (diagnose)

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

100

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Frankrike
- - Nancy, Frankrike
    - CHRU de Nancy

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Barn
Voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	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	Tiltaksbeskrivelse	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

Samarbeidspartnere og etterforskere

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Sponsor

Central Hospital, Nancy, France

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. mai 2024

Primær fullføring (Faktiske)

1. juni 2026

Studiet fullført (Faktiske)

8. juni 2026

Datoer for studieregistrering

Først innsendt

27. juli 2026

Først innsendt som oppfylte QC-kriteriene

11. august 2026

Først lagt ut (Faktiske)

14. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)