NCT04734795

Brief Summary

The purpose of the study is to investigate the prevalence of dysfunctional breathing in children and adolescents with asthma in a hospital outpatient clinic. Participants are invited to take the Nijmegen Questionnaire and the Asthma Control Questionnaire. The prevalence of dysfunctional breathing defined as NQ score \>= 23 is calculated, and demographics are compared between children with and without dysfunctional breathing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
363

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

February 5, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

1.2 years

First QC Date

January 21, 2021

Last Update Submit

October 11, 2022

Conditions

Dysfunctional BreathingAsthma in ChildrenAsthma

Keywords

Dysfunctional breathingAsthma in childrenAsthma in adolescents

Outcome Measures

Primary Outcomes (1)

  • Prevalence of children with dysfunctional breathing defined as Nijmegen Questionnaire ( NQ) Score >= 23

    Nijmegen Questionnaire is a 16 point questionnairre addressing dysfunctional breathing. Each question is scored from 0 (best) to 4 (worst). NQ score is summarized between 0-64 points. NQ score \>= 23 predicts dysfunctional breathing.

    1 year

Secondary Outcomes (8)

  • Mask score

    1 year

  • Asthma Control Questionnaire ( ACQ5)

    1 year

  • Age

    1 year

  • Sex

    1 year

  • Standardised body mass index (BMI_SDS)

    1 year

  • +3 more secondary outcomes

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children and adolecents with asthma in a hospital outpatient clinic

You may qualify if:

  • Asthma diagnosed by lung function tests and/or typical symptoms.
  • Treatment with inhaled corticosteroids in minimum 3 months.

You may not qualify if:

  • Other significant cardiopulmonary or muscoluskeletal conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kolding Sygehus

Kolding, 6000, Denmark

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Signe Vahlkvist

    Kolding Sygehus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 21, 2021

First Posted

February 2, 2021

Study Start

February 5, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

October 13, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie published results, after deidentification.

Shared Documents
SAP
Time Frame
Beginning 3 months and ending 5 years following article publication.
Access Criteria
Researchers who provide a methodologically sound proposal. Proposals should be directed to Open@rsyd.dk.
More information

Locations

DK(1)