Asthma (Diagnosis)PredEIBNCT07766460
Predictive Factors for a Positive Exercise Bronchial Hyperresponsiveness Test
An observational study of Asthma (Diagnosis), run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Asthma (Diagnosis)
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2024to 8 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Children aged 5 to 18 years who performed an exercise challenge test during the years 2024 and 2025
Who cannot join
- Children with doctor-diagnosed asthma
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Asthma (Diagnosis)
- Keywords
- Exercise-induced wheezing, Dyspnea
- Medical subject headings
- Asthma, Disease, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Presence of wheezing at exercise
Presence of reported exercise-induced wheezing, as documented in the subject's electronic medical record (yes/no; binary variable).
Measured: The test duration (3 hours)
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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)
Measured: 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
Measured: The test duration 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start30 May 2024
- Primary completion1 Jun 2026
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Iulia IOAN, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766460
- Sponsor's protocol ID
- 2026PI119
- Acronym
- PredEIB
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for a Positive Exercise Bronchial Hyperresponsiveness Test
- ClinicalTrials.gov ID
- NCT07766460
- Acronym / sponsor ID
- PredEIB / 2026PI119
- Conditions
- Asthma (Diagnosis)
- Keywords
- Exercise-induced wheezing, Dyspnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Children aged 5 to 18 years who performed an exercise challenge test during the years 2024 and 2025
Key exclusion criteria (1 listed)
- Children with doctor-diagnosed asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
7 secondary outcomes
Presence of reported dyspnea at exercise
Time frame: The test duration 3 hours
Presence of reported cough at exercise
Time frame: The test duration 3 hours
Presence of reported chest tightness at exercise
Time frame: The test duration 3 hours
Functional parameters - FEV1 z-score at baseline
Time frame: The test duration 3 hours
Reported atopy
Time frame: The test duration 3 hours
Reported clinical history
Time frame: The test duration 3 hours
Functional parameters - FEV1/FVC z-score at baseline
Time frame: The test duration 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma (Diagnosis), run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of wheezing at exercise (time frame: The test duration (3 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.