Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05162703 |
| Other study ID # |
K 2021-5960 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 27, 2021 |
| Est. completion date |
April 2022 |
Study information
| Verified date |
November 2021 |
| Source |
Region Stockholm |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
