The Prevalence of Dysfunctional Breathing in Children and Adolescents With Asthma

Asthma Clinical Trial

Official title:

The Prevalence of Dysfunctional Breathing in Children and Adolescents With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04734795
• Other study ID #: S-2020-0101-a
• Status: Completed
• Start date: February 5, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: October 2022
• Source: Kolding Sygehus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The purpose of the study is to investigate the prevalence of dysfunctional breathing in children and adolecents with asthma in a hospital outpatient clinic. Participants are invited to take the Nijmegen Questionnaire and the Asthma Control Questionnaire, during appointments at the outpatient clinic. For this study purpose, each participant only takes the questionnairres once. Patient data regarding age, sex, asthma medication, lung function, allergic sensitization, method of asthma diagnose, Height, weight and Body mass index is registered from the electronical patient journal. The prevalence of dysfunctional breathing in the cohort is calculated as the fraction of children with a NQ score >= 23. The group of children and adolescents with dysfunctional breathing is characterized and compared to the group without dysfunctional breathing, regarding the descriptives mentioned above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Other significant cardiopulmonary or muscoluskeletal conditions.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Dysfunctional Breathing
• Respiratory Aspiration

Locations

Country	Name	City	State
Denmark	Kolding Sygehus	Kolding

Sponsors (2)

Lead Sponsor	Collaborator
Kolding Sygehus	Odense Patient Data Explorative Network

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mask score	Because of the ongoing COVID19 pandemic, face mask is acquired in public, and many children are homeschooled. We therefore generated an 8 question survey about the frequency of wearing mask, breathing difficulties while wearing a mask, and weather there is a lock down of school and sports while survey is taken. Questions are scored from 0-3 points, where 0 is Best and 3 is worst	1 year
Secondary	Asthma Control Questionnaire ( ACQ5)	ACQ5 contains 5 questions regarding asthma symptoms. Each question is scored between 0-6 points, where 0 represents very good asthma control and 6 represents poor asthma control. Total ACQ score is calculates as an average of points.	1 year
Secondary	Age	Age in years of study subjects	1 year
Secondary	Sex	Sex of study subjects	1 year
Secondary	Standardised body mass index (BMI_SDS)	Body mass index is calculated as weight ( kg)/ Height ( m) ^2. As BMI changes with age, BMI standard deviation BMI_SDS is calculated from Danish Reference Material : (Tinggaard J, Aksglaede L, Sørensen K, et al (2014) The 2014 Danish references from birth to 20 years for height, weight and body mass index. Acta Paediatr Int J Paediatr. doi: 10.1111/apa.12468)	1 year
Secondary	The reported use of rescue Beta2 agonist in puffs per week	The reported use of short acting beta 2 agonist in puffs per week the last week.	1 year
Secondary	Forced expiratory volume inthe first second in percent of expected Value. ( FEV1%)	Spirometry is performed according to guidelines. FEV1% is calculated by the spirometry software.	1 year
Secondary	Method of asthma diagnose	Fraction of subjects where asthma was diagnosed objectively from lung function variability (reversibility to beta2 agonist OR positive exercise challenge OR positive mannitol challenge). Method of asthma diagnose is noted from the electronical patient journal	1 year