Exercise Induced BronchospasmHYVESNCT03063424
Hyperventilation Versus Exercise Testing Sensitivity in Exercise Induced Asthma
A study testing Eucapnic voluntary hyperventilation and Exercise challenge on a cycle ergometer in people with Exercise Induced Bronchospasm, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The diagnosis of exercise-induced bronchospasm (EIB) is difficult. The metacholine challenge test is not enough specific for the diagnosis of EIB. The exercise challenge test on a cycle ergometer is often use to diagnose this condition. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Induced Bronchospasm
- What is being tested?
- Eucapnic voluntary hyperventilation and Exercise challenge on a cycle ergometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Nov 2019
- Phase
- Interventional
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject should not have a positive history of eczema, urticaria or allergic rhinitis for life.
- The subject should have a FEV1 ≥ 80% of the predicted value and an FEV1 / FVC (Forced vital capacity) ratio of ≥70% at the time of the initial visit.
- The subject should have a negative methacholine test at the first visit of the study.
- The subject should not exhibit symptoms considered clinically compatible with EIB diagnosis.
Who cannot join
- Pregnant or breast-feeding women.
- The subject should not suffer from clinically significant concomitant diseases that may compromise the course of the study.
- The subject should not have taken per os or intravenously steroids in the 8 weeks prior to the study.
- The subject should not have experienced significant symptoms of respiratory tract infection (viral or bacterial) in the 8 weeks prior to the study.
- The subject must not have participated in another study during the month preceding the date of enrollment of this study.
- The subject should not have smoked within the last 6 months.
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- The subject doesn't show up for all 3 visits or doesn't complete all required exams.
- The subject develops a respiratory tract infection, an acute exacerbation of his asthma or any other conditions that compromise his participation in the required examinations.
- The subject has a pre-test FEV1 of less than 80%.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Université de Sherbrooke
Sherbrooke, Quebec, J1G2E8
Katia Carle-Talbot, MD, resident, 514-592-1113 ext. pag 3388, katia.carle-talbot@usherbrooke.ca
Brian Grondin-Beaudoin, MD, 819-346-1110 ext. 14252, Brian.Grondin.Beaudoin@USherbrooke.ca
About this study
The diagnosis of exercise-induced bronchospasm (EIB) is difficult. The metacholine challenge test is not enough specific for the diagnosis of EIB. The exercise challenge test on a cycle ergometer is often use to diagnose this condition. This test has very high specificity, but not enough sensibility because the ventilation achieved during this test is often not big enough to induce a bronchospasm, especially in trained athletes. Eucapnic voluntary hyperventilation (EVH) is the recommended test of the Olympic National committee to establish the diagnosis of EIB, but there are no study comparing the sensibility and specificity of the cycle ergometer challenge test and the isocapnic hyperventilation in an establish population of asthmatics. The investigators assume that the sensitivity and specificity of EVH are higher than those of the cycle ergometer for the diagnosis of EIB in a population of asthmatics with symptoms suggestive of bronchospasm on exertion. In a population of asthmatics with exercise symptoms, what is the sensitivity and specificity of EVH and exercise challenge on a cycle ergometer for the diagnosis of EIB?
- Conditions
- Exercise Induced Bronchospasm
- Being tested
- Eucapnic voluntary hyperventilation, Exercise challenge on a cycle ergometer
- Keywords
- isocapnic voluntary hyperventilation, eucapnic voluntary hyperventilation, exercise induced bronchoconstriction, exercise challenge cycle ergometer
- Medical subject headings
- Asthma, Exercise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eucapnic voluntary hyperventilationDiagnostic test
Exercise challenge on a cycle ergometerDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Other | Not described Receives: Diagnostic Test: Eucapnic voluntary hyperventilation; Diagnostic Test: Exercise challenge on a cycle ergometer |
| Asthmatics with EIB | Other | Not described Receives: Diagnostic Test: Eucapnic voluntary hyperventilation; Diagnostic Test: Exercise challenge on a cycle ergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the sensitivity and specificity of eucapnic voluntary hyperventilation versus exercise challenge testing on a cycle ergometer for exercise-induced bronchospasm diagnosis in established asthmatic subjects with exercise symptoms.
Measured: through study completion, an average of 1 month
Secondary outcomes (2)
Correlate the magnitude of exercise bronchoconstriction during EVH and exercise challenge testing on a cycle ergometer (measurement of FEV1 before and after these tests) with severity of symptoms of EIB (with questionnaires)
The questionnaires for the severity of symptoms of EIB will include a modified Borg questionnaire, symptoms of EIB after the tests and usual symptoms of EIB after a vigorous effort.
Measured: through study completion, an average of 1 month
Correlate the magnitude of exercise bronchoconstriction during EVH and exercise challenge testing on a cycle ergometer (FEV1 before and after these tests) with severity of bronchial hyperreactivity evaluated by methacholine challenge test (MCT).
severity of bronchial hyperreactivity evaluated by methacholine challenge test (MCT) will be measured with the provocative concentration causing a 20% fall in FEV1 (PC20) (mg/ml) as recommended by the American Thoracic Society (ATS).
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study startJun 2011
- Primary completionOct 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Induced BronchospasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Grondin-Beaudoin, Université de Sherbrooke
- Investigators
- Pierre Larivée, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063424
- Sponsor's protocol ID
- 10-074
- Acronym
- HYVES
- Status last verified
- Jun 2019
- First submitted
- 22 Jan 2017
- Last updated
- 4 Jun 2019
- 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 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperventilation Versus Exercise Testing Sensitivity in Exercise Induced Asthma
- ClinicalTrials.gov ID
- NCT03063424
- Acronym / sponsor ID
- HYVES / 10-074
- Conditions
- Exercise Induced Bronchospasm
- Keywords
- isocapnic voluntary hyperventilation, eucapnic voluntary hyperventilation, exercise induced bronchoconstriction, exercise challenge cycle ergometer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 24 Feb 2017 (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.
The diagnosis of exercise-induced bronchospasm (EIB) is difficult. The metacholine challenge test is not enough specific for the diagnosis of EIB. The exercise challenge test on a cycle ergometer is often use to diagnose this condition. This test has very high specificity, but not enough sensibility because the ventilation achieved during this test is often not big enough to induce a bronchospasm, especially in trained athletes. Eucapnic voluntary hyperventilation (EVH) is the recommended test of the Olympic National committee to establish the diagnosis of EIB, but there are no study comparing the sensibility and specificity of the cycle ergometer challenge test and the isocapnic hyperventilation in an establish population of asthmatics. The investigators assume that the sensitivity and specificity of EVH are higher than those of the cycle ergometer for the diagnosis of EIB in a population of asthmatics with symptoms suggestive of bronchospasm on exertion. In a population of asthmatics with exercise symptoms, what is the sensitivity and specificity of EVH and exercise challenge on a cycle ergometer for the diagnosis of EIB?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Other | Diagnostic Test: Eucapnic voluntary hyperventilation, Diagnostic Test: Exercise challenge on a cycle ergometer |
| Asthmatics with EIB | Other | Diagnostic Test: Eucapnic voluntary hyperventilation, Diagnostic Test: Exercise challenge on a cycle ergometer |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The subject should not have a positive history of eczema, urticaria or allergic rhinitis for life.
- The subject should have a FEV1 ≥ 80% of the predicted value and an FEV1 / FVC (Forced vital capacity) ratio of ≥70% at the time of the initial visit.
- The subject should have a negative methacholine test at the first visit of the study.
- The subject should not exhibit symptoms considered clinically compatible with EIB diagnosis.
Key exclusion criteria (9 listed)
- Pregnant or breast-feeding women.
- The subject should not suffer from clinically significant concomitant diseases that may compromise the course of the study.
- The subject should not have taken per os or intravenously steroids in the 8 weeks prior to the study.
- The subject should not have experienced significant symptoms of respiratory tract infection (viral or bacterial) in the 8 weeks prior to the study.
- The subject must not have participated in another study during the month preceding the date of enrollment of this study.
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 |
|---|---|---|
| Eucapnic voluntary hyperventilation | Diagnostic test | Asthmatics with EIB, Healthy subjects |
| Exercise challenge on a cycle ergometer | Diagnostic test | Asthmatics with EIB, Healthy subjects |
Primary outcome
Compare the sensitivity and specificity of eucapnic voluntary hyperventilation versus exercise challenge testing on a cycle ergometer for exercise-induced bronchospasm diagnosis in established asthmatic subjects with exercise symptoms.
Time frame: through study completion, an average of 1 month
2 secondary outcomes
Correlate the magnitude of exercise bronchoconstriction during EVH and exercise challenge testing on a cycle ergometer (measurement of FEV1 before and after these tests) with severity of symptoms of EIB (with questionnaires)
Time frame: through study completion, an average of 1 month
Correlate the magnitude of exercise bronchoconstriction during EVH and exercise challenge testing on a cycle ergometer (FEV1 before and after these tests) with severity of bronchial hyperreactivity evaluated by methacholine challenge test (MCT).
Time frame: through study completion, an average of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- 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.
Pierre Larivée principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eucapnic voluntary hyperventilation and Exercise challenge on a cycle ergometer in people with Exercise Induced Bronchospasm, run by Université de Sherbrooke at 1 site in Canada.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 4 Jun 2019. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian Grondin-Beaudoin (819-346-1110 ext. 14252, Brian.Grondin.Beaudoin@USherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the sensitivity and specificity of eucapnic voluntary hyperventilation versus exercise challenge testing on a cycle ergometer for exercise-induced bronchospasm diagnosis in established asthmatic subjects with exercise symptoms. (time frame: through study completion, an average of 1 month). 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 Jun 2019.