NCT07766460

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

July 27, 2026

Last Update Submit

August 11, 2026

Conditions

Keywords

Exercise-induced wheezingDyspnea

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Presence of reported dyspnea at exercise

    The test duration 3 hours

  • Presence of reported cough at exercise

    The test duration 3 hours

  • Presence of reported chest tightness at exercise

    The test duration 3 hours

  • Functional parameters - FEV1 z-score at baseline

    The test duration 3 hours

  • Reported atopy

    The test duration 3 hours

  • +2 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Children aged 5 to 18 years who performed an exercise challenge test during the years 2024 and 2025

You may not qualify if:

  • Children with doctor-diagnosed asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Nancy, France

Location

MeSH Terms

Conditions

AsthmaDiseaseDyspnea

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor MD PhD

Study Record Dates

First Submitted

July 27, 2026

First Posted

August 14, 2026

Study Start

May 30, 2024

Primary Completion

June 1, 2026

Study Completion

June 8, 2026

Last Updated

August 14, 2026

Record last verified: 2026-08

Locations