ClinicalTrials.gg
Status unknownNCT03063424HYVESUpdated Jun 4, 2019

Hyperventilation Versus Exercise Testing Sensitivity in Exercise Induced Asthma

An interventional study of Eucapnic voluntary hyperventilation and Exercise challenge on a cycle ergometer in Exercise Induced Bronchospasm, sponsored by Université de Sherbrooke. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-04.

Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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?

02

Conditions studied

  • Exercise Induced Bronchospasm

Keywords

  • isocapnic voluntary hyperventilation
  • eucapnic voluntary hyperventilation
  • exercise induced bronchoconstriction
  • exercise challenge cycle ergometer
03

In context

Asthma, Exercise-Induced

52 studies on the registry are indexed under Asthma, Exercise-Induced; 3 are open to participants now.

This study's planned enrollment of 40 is below the median of 47 across 40 interventional studies indexed under Asthma, Exercise-Induced.

Browse Asthma, Exercise-Induced studies →

Lead sponsor

Université de Sherbrooke is the lead sponsor of 295 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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 () ≥ 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 concomitant diseases that may compromise the course of the study.
  • The subject should not have taken per os or intravenously 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%.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • 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

Interventions

  • Diagnostic testEucapnic voluntary hyperventilation
  • Diagnostic testExercise challenge on a cycle ergometer
06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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.

    Time frame: through study completion, an average of 1 month

  2. 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).

    Time frame: through study completion, an average of 1 month

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2011, a primary completion of Oct 2019 and a completion of Nov 2019. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2017
First posted
Feb 24, 2017
Start
Jun 2011
Primary completionEst.
Oct 2019
CompletionEst.
Nov 2019
Last update
Jun 4, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03063424
Responsible party
Brian Grondin-Beaudoin (Clinical Professor, Principal Investigator, Université de Sherbrooke) — Principal investigator
First posted
Feb 24, 2017
Start date
Jun 2011
Primary completion
Oct 2019 (estimated)
Completion
Nov 2019 (estimated)
Last update
Jun 4, 2019

Study contacts

Brian Grondin-Beaudoin
Contact
Brian.Grondin.Beaudoin@USherbrooke.ca
819-346-1110 ext. 14252
Katia Carle-Talbot
Contact
katia.carle-talbot@usherbrooke.ca
514-592-1113 ext. pag 0477
Pierre Larivée
principal investigator · Université de Sherbrooke

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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