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Exercise Induced AsthmaNCT05162703

Evaluation of Exercise Induced Bronchoconstriction Using a Novel Automated Digital Clinical Decision System

A study testing AsthmaTuner in people with Exercise Induced Asthma and Exercise Induced Bronchospasm, run by Region Stockholm at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The primary objective of this study is to assess if the unstandardized field exercise challenge test (ECT) using AsthmaTuner can be performed independently by youths that have been investigated for asthma. This is an open feasibility study including youths who have been investigated for asthma. Read more about this study

Who is it for?
Ages 15 to 20 yearsHealthy volunteers can take part
What is being tested?
AsthmaTuner
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSweden
Study dates
27 Sep 2021to Apr 2022
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Current or previous investigation for exercise induced asthma and have performed a standardised exercise challenge test at Astrid Lindgren's Children's Hospital in the last 2 years.

Who cannot join

  • Other medical conditions or medications that interfere with asthma or respiratory tract infection in the last two weeks.

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Astrid Lindgren Children's Hospital, Karolinska University Hospital

    Stockholm

Other trials in Sweden

About this study

Official title: Evaluation of Exercise Induced Bronchoconstriction by Field Test Using Lung Function and a Novel Automated Digital Clinical Decision System (DFET)

The primary objective of this study is to assess if the unstandardized field exercise challenge test (ECT) using AsthmaTuner can be performed independently by youths that have been investigated for asthma. This is an open feasibility study including youths who have been investigated for asthma. Participants will be equipped with a digital spirometer and mobile phone app to perform an exercise tests in their natural training environment. Feasibility will be evaluated using questionnaires.

Read the detailed description

Asthma is the most common chronic condition in athletes and people who exercise regularly. Asthma is defined as a chronic inflammation in the airways associated with bronchial hyper responsiveness (BHR). While exercise-induced "sports" asthma (EIA) describes symptoms and signs of asthma provoked by exercise, exercise-induced bronchoconstriction (EIB) is defined as the transient narrowing of the lower airway after exercise. In the general population, EIB with or without asthma affects 5% to 20%, but the rate is estimated to be even higher in top athletes participating in winter and summer endurance sports.

Asthma and EIB represents an important challenge in both athletes and the general population, and correct diagnosis is important as it affects health as well as performance.

Presence of BHR is demonstrated by direct or indirect bronchial provocation testing. Indirect bronchial provocation includes several methods for the diagnosis of EIB. The most intuitive is exercise (field and laboratory) challenge testing (ECT), but sensitivity has been reported to be low, since exercise load and intensity have large impact on ability to detect EIB and in field-testing (FT), standardizing ambient conditions are impossible.

Suboptimal tests for EIB may explain why previous papers report poor relationship between symptoms of EIA and the objective EIB in athletes, leaving the actual rate of EIB remains unclear. What has been argued to be the true "gold standard" is a sports-specific exercise FT, performed in the actual training conditions which also makes it easier for the athlete to perform at maximum exercise. The advantages of monitoring with peak expiratory flow (PEF) or forced expiratory volume in 1 s (FEV1) outside a laboratory with a PEF meter or spirometer, respectively, are that it is simple and cheap. It also enables measure of bronchial challenge testing in close relationship to symptoms, since laboratory bronchial challenge testing often are negative in subjects being away from their profession too long. However, traditional non-digital method of serial PEF/FEV1 monitoring has limitations with poor adherence, interpretation difficulties with objectivity and time-consuming analysis and reading of paper PEF/FEV1 plots.

Recently, AsthmaTuner (Medituner AB) consisting of a patient smartphone application, a portable wireless spirometer for measuring lung function (PEF/FEV1), and a healthcare interface including treatment plan, was reported to significantly improve management of uncontrolled asthma. Such electronically clinical decision support systems (CDSS) has gained acceptance for the diagnosis of asthma, and by the ability to assess patient generated data in field ECTs, the CE-marked AsthmaTuner may provide athletes a feasible, time and cost-efficient self-monitoring of EIB and asthma. AsthmaTuner may also empower athletes in monitoring their lung function over time. These lung function measurements contain unexpected amounts of information for identifying athletes with distinct phenotypes of EIB due to strenuous sports and environmental conditions. Hence, AsthmaTuner have the potential to fill the knowledge gap regarding prevalence of EIB, development of EIB and the lack of association between symptoms and detection of EIB in athletes.

The primary objective of this study is to assess if the unstandardized field exercise challenge test (ECT) using AsthmaTuner can be performed independently by youths that have been investigated for asthma. This is an open feasibility study including youths who have been investigated for asthma. Participants will be equipped with a spirometer and and the AsthmaTuner mobile phone app to perform an exercise tests in their natural training environment. Feasibility will be evaluated using questionnaires.

Being tested
AsthmaTuner
Medical subject headings
Asthma, Exercise-Induced

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AsthmaTunerDiagnostic test

    Exercise challenge test using AsthmaTuner mobile phone app and spirometer.

Study groups in NCT05162703
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants will be equipped with a spirometer and and the AsthmaTuner mobile phone app to perform an exercise tests in their natural training environment. Feasibility will be evaluated using questionnaires.
Receives: Diagnostic Test: AsthmaTuner

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ability to perform test

    Number of participants who completed the test

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2021
  2. Study start27 Sep 2021
  3. Primary completion14 Mar 2022 (estimated)
  4. Study completionApr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05162703
Sponsor's protocol ID
K 2021-5960
Status last verified
Nov 2021
First submitted
12 Nov 2021
Last updated
17 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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