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Hyperventilation Versus Exercise Testing Sensitivity in Exercise Induced Asthma (HYVES)

Primary Purpose

Exercise Induced Bronchospasm

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Eucapnic voluntary hyperventilation
Exercise challenge on a cycle ergometer
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Exercise Induced Bronchospasm focused on measuring isocapnic voluntary hyperventilation, eucapnic voluntary hyperventilation, exercise induced bronchoconstriction, exercise challenge cycle ergometer

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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%.

Sites / Locations

  • Université de SherbrookeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Healthy subjects

Asthmatics with EIB

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
January 22, 2017
Last Updated
June 1, 2019
Sponsor
Université de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT03063424
Brief Title
Hyperventilation Versus Exercise Testing Sensitivity in Exercise Induced Asthma
Acronym
HYVES
Official Title
Hyperventilation Versus Exercise Testing Sensitivity in Exercise Induced Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Induced Bronchospasm
Keywords
isocapnic voluntary hyperventilation, eucapnic voluntary hyperventilation, exercise induced bronchoconstriction, exercise challenge cycle ergometer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy subjects
Arm Type
Other
Arm Title
Asthmatics with EIB
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Eucapnic voluntary hyperventilation
Intervention Type
Diagnostic Test
Intervention Name(s)
Exercise challenge on a cycle ergometer
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
through study completion, an average of 1 month
Title
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).
Description
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).
Time Frame
through study completion, an average of 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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%.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Grondin-Beaudoin
Phone
819-346-1110
Ext
14252
Email
Brian.Grondin.Beaudoin@USherbrooke.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Katia Carle-Talbot
Phone
514-592-1113
Ext
pag 0477
Email
katia.carle-talbot@usherbrooke.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Larivée
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G2E8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katia Carle-Talbot, MD, resident
Phone
514-592-1113
Ext
pag 3388
Email
katia.carle-talbot@usherbrooke.ca
First Name & Middle Initial & Last Name & Degree
Brian Grondin-Beaudoin, MD
Phone
819-346-1110
Ext
14252
Email
Brian.Grondin.Beaudoin@USherbrooke.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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