Childhood AsthmaSouProvocBroNCT03696602
More Relaxation by Deep Breath on Methacholine
An observational study of Childhood Asthma, run by Central Hospital, Nancy, France.
Trial summary
Deep inhalation (DI) dilates normal airway precontracted with methacholine. The fact that this effect is diminished or absent in asthma could be explained by the presence of bronchial inflammation. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Childhood Asthma
- What is being tested?
- bronchial provocation test
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2006to 30 Sep 2016
- 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Seventy-three asthmatic children (48 boys) were selected, 37 underwent exercise challenge and 36 methacholine.
Who may be able to join
- Children referred to the lung function department by their pediatric pulmonologist.
- Asthma defined by a complaint of wheezing, cough and dyspnoea.
- Positive response to methacholine or exercise challenge.
- Bronchodilator medications discontinued at least 12 h prior to the testing
- Provocation allowed when the child had been free of respiratory symptoms for at least 2 weeks and baseline FEV1 larger than 70% pred.
Who cannot join
- Other respiratory diseases than asthma
About this study
Official title: More Relaxation by Deep Breath on Methacholine- Than on Exercise-Induced Bronchoconstriction During the Routine Testing of Asthmatic Children
Deep inhalation (DI) dilates normal airway precontracted with methacholine. The fact that this effect is diminished or absent in asthma could be explained by the presence of bronchial inflammation. The hypothesis tested was that DI induces more relaxation in methacholine induced bronchoconstriction-solely determined by the smooth muscle contraction-than in exercise induced bronchoconstriction, which is contributed to by both smooth muscle contraction and airway wall inflammation.
Read the detailed description
Children were referred to the lung function department by their pediatric pulmonologist. Asthma was defined by a complaint of wheezing, cough, dyspnoea or chest tightness at rest or on exercising and a positive response to methacholine or exercise challenge.
The response to exercise was considered positive when Forced Expiratory Volume in 1 s (FEV1) decreased at least 8% from Baseline.
The response to methacholine was considered positive when FEV1 decreased at least 20% or Rrs increased at least 50% from baseline, at or below a cumulated dose of 1,200 μg.
Bronchodilator medications were discontinued at least 12 hours prior to the testing and provocation allowed when the child had been free of respiratory symptoms for at least 2 weeks and baseline FEV1 was larger than 70% pred. Exercise and methacholine groups were matched for age, height, baseline FEV1 z-score, a moderate level of airway response to challenge and DI amplitude ranging 40-60% of the predicted Forced Vital Capacity (FVC). Written informed consent was obtained from the children and their parents for the procedures. Procedures for spirometry, exhaled fraction of NO (FENO), GrsDI (Respiratory conductance response to a deep inhalation) and challenges have been described previously. Acceptable GrsDI's were analyzed at a 10-20% FEV1 decrease from baseline. Statistics were performed using Mann-Whitney, Chi square tests and multiple regression as required. Data are median and interquartile range.
- Conditions
- Childhood Asthma
- Being tested
- bronchial provocation test
- Keywords
- airway smooth muscle, asthma, bronchial test, lung function
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchial provocation testDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| test with methacholine | Not described Receives: Diagnostic Test: bronchial provocation test | |
| test with exercise | Not described Receives: Diagnostic Test: bronchial provocation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grs change between before deep breath and after deep breath in exercise and metacholine groups
GrsDI represents Grs measured after deep breath reported to Grs before deep breath (bronchial provocation test)
Measured: through study completion, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start1 Jul 2006
- Primary completion30 Jun 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood AsthmaStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696602
- Sponsor's protocol ID
- enf4327
- Acronym
- SouProvocBro
- Status last verified
- Sep 2018
- First submitted
- 21 Sep 2018
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- More Relaxation by Deep Breath on Methacholine- Than on Exercise-Induced Bronchoconstriction During the Routine Testing of Asthmatic Children
- ClinicalTrials.gov ID
- NCT03696602
- Acronym / sponsor ID
- SouProvocBro / enf4327
- Conditions
- Childhood Asthma
- Keywords
- airway smooth muscle, asthma, bronchial test, lung function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jul 2006 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 4 Oct 2018 (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.
Deep inhalation (DI) dilates normal airway precontracted with methacholine. The fact that this effect is diminished or absent in asthma could be explained by the presence of bronchial inflammation. The hypothesis tested was that DI induces more relaxation in methacholine induced bronchoconstriction-solely determined by the smooth muscle contraction-than in exercise induced bronchoconstriction, which is contributed to by both smooth muscle contraction and airway wall inflammation.
Detailed description
Children were referred to the lung function department by their pediatric pulmonologist. Asthma was defined by a complaint of wheezing, cough, dyspnoea or chest tightness at rest or on exercising and a positive response to methacholine or exercise challenge.
The response to exercise was considered positive when Forced Expiratory Volume in 1 s (FEV1) decreased at least 8% from Baseline.
The response to methacholine was considered positive when FEV1 decreased at least 20% or Rrs increased at least 50% from baseline, at or below a cumulated dose of 1,200 μg.
Bronchodilator medications were discontinued at least 12 hours prior to the testing and provocation allowed when the child had been free of respiratory symptoms for at least 2 weeks and baseline FEV1 was larger than 70% pred. Exercise and methacholine groups were matched for age, height, baseline FEV1 z-score, a moderate level of airway response to challenge and DI amplitude ranging 40-60% of the predicted Forced Vital Capacity (FVC). Written informed consent was obtained from the children and their parents for the procedures. Procedures for spirometry, exhaled fraction of NO (FENO), GrsDI (Respiratory conductance response to a deep inhalation) and challenges have been described previously. Acceptable GrsDI's were analyzed at a 10-20% FEV1 decrease from baseline. Statistics were performed using Mann-Whitney, Chi square tests and multiple regression as required. Data are median and interquartile range.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test with methacholine | – | Diagnostic Test: bronchial provocation test |
| test with exercise | – | Diagnostic Test: bronchial provocation test |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Seventy-three asthmatic children (48 boys) were selected, 37 underwent exercise challenge and 36 methacholine.
Key inclusion criteria (5 listed)
- Children referred to the lung function department by their pediatric pulmonologist.
- Asthma defined by a complaint of wheezing, cough and dyspnoea.
- Positive response to methacholine or exercise challenge.
- Bronchodilator medications discontinued at least 12 h prior to the testing
- Provocation allowed when the child had been free of respiratory symptoms for at least 2 weeks and baseline FEV1 larger than 70% pred.
Key exclusion criteria (1 listed)
- Other respiratory diseases than asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bronchial provocation test | Diagnostic test | test with exercise, test with methacholine |
Primary outcome
Grs change between before deep breath and after deep breath in exercise and metacholine groups
Time frame: through study completion, an average of 1 hour
GrsDI represents Grs measured after deep breath reported to Grs before deep breath (bronchial provocation test)
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 4 Oct 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Asthma, run by Central Hospital, Nancy, 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 5 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 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Grs change between before deep breath and after deep breath in exercise and metacholine groups (time frame: through study completion, an average of 1 hour). 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 4 Oct 2018; AzTrials last refreshed its copy on 1 Nov 2026.