- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07766460
Predictive Factors for a Positive Exercise Bronchial Hyperresponsiveness Test (PredEIB)
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Nancy, Frankrike
- CHRU de Nancy
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Presence of wheezing at exercise
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Presence of reported dyspnea at exercise
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Immunsystemets sjukdomar
- Luftvägssjukdomar
- Lungsjukdomar
- Andningsstörningar
- Bronkialsjukdomar
- Lungsjukdomar, obstruktiv
- Respiratorisk överkänslighet
- Överkänslighet, Omedelbar
- Överkänslighet
- Tecken och symtom, andningsvägar
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Astma
- Sjukdom
- Dyspné
Andra studie-ID-nummer
- 2026PI119
Plan för individuella deltagardata (IPD)
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