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Hyperventilation Versus Exercise Testing Sensitivity in Exercise Induced Asthma

Hyperventilation Versus Exercise Testing Sensitivity in Exercise Induced Asthma

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03063424
Acronym
HYVES
Enrollment
40
Registered
2017-02-24
Start date
2011-06-30
Completion date
2019-11-30
Last updated
2019-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Induced Bronchospasm

Keywords

isocapnic voluntary hyperventilation, eucapnic voluntary hyperventilation, exercise induced bronchoconstriction, exercise challenge cycle ergometer

Brief 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. 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?

Interventions

DIAGNOSTIC_TESTEucapnic voluntary hyperventilation
DIAGNOSTIC_TESTExercise challenge on a cycle ergometer

Sponsors

Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

for the group exercise-induced bronchospasm: * The subject must have a diagnosis of asthma according to 2010 Canadian Thoracic Society consensus criteria since more then one year. * The subject should have an average expiratory volume per second (FEV1) ≥ 80% of the predicted value (post bronchodilatation) at the time of the initial visit. * The subject must have had a positive methacholine test at the first visit of the study demonstrating the presence of bronchial hyperreactivity. * The subject must have asthma control as defined by 2010 Canadian Thoracic Society consensus, with the obvious exception of limitations related to physical activity. * The subject must have at the questionnaire significant symptoms of exercise-induced bronchospasm for more than 6 months. Inclusion Criteria for the group healthy: * 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
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.through study completion, an average of 1 month

Secondary

MeasureTime frameDescription
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)through study completion, an average of 1 monthThe 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.
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).through study completion, an average of 1 monthseverity 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).

Countries

Canada

Contacts

Primary ContactBrian Grondin-Beaudoin
Brian.Grondin.Beaudoin@USherbrooke.ca819-346-1110
Backup ContactKatia Carle-Talbot
katia.carle-talbot@usherbrooke.ca514-592-1113

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026