NCT05162703

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 17, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2022

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

December 17, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

November 12, 2021

Last Update Submit

December 6, 2021

Conditions

Exercise Induced AsthmaExercise Induced BronchospasmPediatric Respiratory Diseases

Outcome Measures

Primary Outcomes (1)

  • Ability to perform test

    Number of participants who completed the test

    2 weeks

Study Arms (1)

Intervention group

EXPERIMENTAL

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

AsthmaTunerDIAGNOSTIC_TEST

Exercise challenge test using AsthmaTuner mobile phone app and spirometer.

Intervention group

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Astrid Lindgren Children's Hospital, Karolinska University Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Asthma, Exercise-Induced

Condition Hierarchy (Ancestors)

AsthmaBronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityExercise-Induced AllergiesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Henrik Ljungberg

    henrik.ljungberg@regionstockholm.se

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2021

First Posted

December 17, 2021

Study Start

September 27, 2021

Primary Completion

March 14, 2022

Study Completion

April 1, 2022

Last Updated

December 17, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)