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Status unknownNCT05162703Updated Dec 17, 2021

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

An interventional study of AsthmaTuner in Exercise Induced Asthma, Exercise Induced Bronchospasm and Pediatric Respiratory Diseases, sponsored by Region Stockholm. Status unknown at 1 site in Sweden. Open to participants aged 15 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-17.

Sponsored by Region Stockholm · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
15 Years to 20 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Exercise Induced Asthma
  • Exercise Induced Bronchospasm
  • Pediatric Respiratory Diseases
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 15 is below the median of 47 across 40 interventional studies indexed under Asthma, Exercise-Induced.

Browse Asthma, Exercise-Induced studies →

Lead sponsor

Region Stockholm is the lead sponsor of 121 studies on the registry; 69 are open to participants now.

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

04

Who can participate

Ages eligible
15 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Intervention group

    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.

    Diagnostic Test: AsthmaTuner

Interventions

  • Diagnostic testAsthmaTuner

    Exercise challenge test using AsthmaTuner mobile phone app and spirometer.

06

What researchers measure

Primary outcomes

  1. Ability to perform test

    Number of participants who completed the test

    Time frame: 2 weeks

07

Study locations

1 site
  • Astrid Lindgren Children's Hospital, Karolinska University Hospital
    Stockholm, Sweden
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2021 (actual). Primary completion is estimated for Mar 2022, 5 months after the start.

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

Registered
Nov 12, 2021
First posted
Dec 17, 2021
StartActual
Sep 27, 2021
Primary completionEst.
Mar 14, 2022
CompletionEst.
Apr 2022
Last update
Dec 17, 2021
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 Dec 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05162703
Lead sponsor
Region Stockholm
Responsible party
Sponsor
First posted
Dec 17, 2021
Start date
Sep 27, 2021
Primary completion
Mar 14, 2022 (estimated)
Completion
Apr 2022 (estimated)
Last update
Dec 17, 2021

Study contacts

Henrik Ljungberg
study chair · henrik.ljungberg@regionstockholm.se

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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