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

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 Overview

• Status: Unknown
• Conditions: Exercise Induced Bronchospasm
• Intervention / Treatment: Diagnostic test: Eucapnic voluntary hyperventilation; Diagnostic test: Exercise challenge on a cycle ergometer

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1G2E8
      • Recruiting
      • Université de Sherbrooke
      • Contact: Katia Carle-Talbot, MD, resident; Phone Number: pag 3388 514-592-1113; Email: katia.carle-talbot@usherbrooke.ca
      • Contact: Brian Grondin-Beaudoin, MD; Phone Number: 14252 819-346-1110; Email: Brian.Grondin.Beaudoin@USherbrooke.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy subjects	Diagnostic test: Eucapnic voluntary hyperventilation; Diagnostic test: Exercise challenge on a cycle ergometer
Other: Asthmatics with EIB	Diagnostic test: Eucapnic voluntary hyperventilation; Diagnostic test: Exercise challenge on a cycle ergometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	through study completion, an average of 1 month

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Investigators: Principal Investigator: Pierre Larivée, Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: January 22, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): June 4, 2019
• Last Update Submitted That Met QC Criteria: June 1, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: eucapnic voluntary hyperventilation; isocapnic voluntary hyperventilation; exercise induced bronchoconstriction; exercise challenge cycle ergometer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Hypersensitivity, Immediate; Bronchial Diseases; Signs and Symptoms, Respiratory; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Bronchial Spasm; Asthma, Exercise-Induced; Hyperventilation
• Other Study ID Numbers: 10-074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No