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Completed

NCT Number: NCT07766460

Predictive Factors for a Positive Exercise Bronchial Hyperresponsiveness Test

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.

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Key information

Conditions

Asthma (Diagnosis) Asthma Bronchial Diseases Disease Dyspnea Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Nancy

Nancy, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Presence of wheezing at exercise

    Time frame: The test duration (3 hours)

    Presence of reported exercise-induced wheezing, as documented in the subject's electronic medical record (yes/no; binary variable).

Secondary outcomes

  1. Presence of reported dyspnea at exercise

    Time frame: The test duration 3 hours

    Presence of reported exercise-induced dyspnea, as documented in the subject's electronic medical record (yes/no; binary variable).

  2. Presence of reported cough at exercise

    Time frame: The test duration 3 hours

    Presence of reported exercise-induced cough, as documented in the subject's electronic medical record (yes/no; binary variable).

  3. Presence of reported chest tightness at exercise

    Time frame: 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).

  4. Functional parameters - FEV1 z-score at baseline

    Time frame: 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

  5. Reported atopy

    Time frame: The test duration 3 hours

    Presence of asthma or atopy history, as documented in the subject's electronic medical record (yes/no; binary variable).

  6. Reported clinical history

    Time frame: 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)

  7. Functional parameters - FEV1/FVC z-score at baseline

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: PredEIB

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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