Recruiting

Hyperventilation vs. Exercise

Sponsor:

Université de Sherbrooke

Code:

NCT03063424

Conditions

Exercise Induced Bronchospasm

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Eucapnic voluntary hyperventilation

Exercise challenge on a cycle ergometer

Study Details

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?

Conditions

Exercise Induced Bronchospasm

Study ID

NCT03063424

Start date

Jun, 2011

Status verified date

Jun, 2019

Completion date

Nov, 2019

Anticipated

Primary completion date

Oct, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

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.

Exclusion criteria during the study:

  • 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%.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Healthy subjects

other: Asthmatics with EIB

Interventions

Eucapnic voluntary hyperventilation

Exercise challenge on a cycle ergometer

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 ]

Central Contacts and Locations

Central contacts

Brian Grondin-Beaudoin

819-346-1110Brian.Grondin.Beaudoin@USherbrooke.ca

Katia Carle-Talbot

514-592-1113katia.carle-talbot@usherbrooke.ca

Locations

Université de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1G2E8

Contacts

Katia Carle-Talbot, MD, resident

514-592-1113katia.carle-talbot@usherbrooke.ca

Brian Grondin-Beaudoin, MD

819-346-1110Brian.Grondin.Beaudoin@USherbrooke.ca

More Information

Sponsor

Université de Sherbrooke

Last update posted

Jun 4, 2019

Last verified

Jun, 2019

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2019-06-04.