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

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.

Study Overview

• Status: Completed
• Conditions: Asthma (Diagnosis)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Nancy, France
    • CHRU de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of wheezing at exercise	Presence of reported exercise-induced wheezing, as documented in the subject's electronic medical record (yes/no; binary variable).	The test duration (3 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of reported dyspnea at exercise	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	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Actual): June 1, 2026
• Study Completion (Actual): June 8, 2026

Study Registration Dates

• First Submitted: July 27, 2026
• First Submitted That Met QC Criteria: August 11, 2026
• First Posted (Actual): August 14, 2026

Study Record Updates

• Last Update Posted (Actual): August 14, 2026
• Last Update Submitted That Met QC Criteria: August 11, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Dyspnea; Exercise-induced wheezing
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Asthma; Disease; Dyspnea
• Other Study ID Numbers: 2026PI119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No