Exercise Induced Bronchoconstriction and Field Tests

NCT04275648 | Completed

• 1 other identifier: V.4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma and exercise induced bronchoconstriction (EIB) represent an important challenge for the athlete, and correct diagnosis is important as it affects health as well as performance with strict regulations concerning asthma medication. The primary objective of this study on elite athletes with symptoms of EIB, is to assess if EIB can be determined equally by repeated standardized and unstandardized field ECT using AsthmaTuner, and eucapnic voluntary hypernoea (EVH). Methods: The study has an open design including elite athletes with symptoms of EIB. They will be equipped with an AsthmaTuner to perform 3-5 repeated exercise tests with AsthmaTuner in their natural training and competing environment, followed by an EVH test within four weeks after the first visit. Olympiatoppen is a national clinic in Oslo, Norway, providing health care and screening of elite athletes. At least 60 elite athletes aged 16 to 50 years with a history of EIB symptoms within the last 8 weeks will be invited to participate. The eucapnic voluntarily hyperventilation (EVH) test and two standardized field exercise test will be performed according to guidelines. In addition, the participants will be encouraged to perform unstandardized lung function tests in relation to perceived respiratory symptoms during exercise.

Conditions

Exercise Induced Bronchoconstriction; Asthma

Outcome Measures

Primary Outcomes (1)

• Standardized field exercise test

  Forced expiratory volume of one second (FEV1), given by the AsthmaTuner

  Change from baseline FEV1 by 30 minutes post exercise

Secondary Outcomes (3)

• Unstandardised field exercise test

  Change from baseline FEV1 by 30 minutes post exercise

• EVH

  Change from baseline FEV1 by 20 minutes post EVH challenge

• Bronchial hyperresponsiveness

  Change from baseline FEV1 at 1 minute of last dose given 20% reduction of FEV1 according to the standardised protocol

Study Arms (1)

Asthmatuner field tests vs laboratory tests

EXPERIMENTAL

Each participant will perform two standardized field tests either before or after Eucapnic Voluntary Hyperpnea or Methacholine bronchial provocation test. In addition, unstandardized field tests will be performed in case of exercise induced respiratory symptoms.

Diagnostic Test: AsthmaTuner exercise field test

Interventions

AsthmaTuner exercise field test DIAGNOSTIC_TEST

AsthmaTuner consist of a a bluetooth spirometer and smartphone app with protocol for measuring lung function (FEV1) and perform 8 min exercise challenge test and a healthcare web interface.

Also known as: AsthmaTuner

Asthmatuner field tests vs laboratory tests

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• History of EIB symptoms within the last 8 weeks will be invited to participate

You may not qualify if:

• Additional asthma treatment until completion of the study.
• Athletes will be excluded if any of following criterion is fulfilled; FEV1 \<75%, a forced vital capacity \<80%, a recent course of oral corticosteroids or infections, as well as pregnancy, chronic diseases or inability to perform the study procedures.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Olympiatoppen, The Norwegian Olympic Sports Centre, Oslo, Norway: collaborator
• Norwegian School of Sport Sciences: collaborator

Study Sites (1)

Olympiatoppen

Oslo, Norway

Location

Related Publications (24)

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  PMID: 37520311 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Björn Nordlund, PhD

  Women's and Children's Health, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 19, 2020
• Study Start: December 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: August 26, 2025

Record last verified: 2022-06

Locations

NO (1)