Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480084
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-02-12
Brief Title:
Prevalence of EILO Among Children With Asthma
Sponsor:
Medisch Spectrum Twente
Organization:
Medisch Spectrum Twente
Study Overview
Official Title:
The Prevalence of Exercise-Induced Laryngeal Obstruction EILO Amongst Children With Asthma - a Prospective Cross-sectional Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this cross-sectional study is to investigate the prevalence of Exercise Induced Laryngeal Obstruction EILO in children with asthma
The hypothesis is that the prevalence will be around 15 which is higher than the prevalence of 5-8 among the general adolescent population This is based on the increased prevalence of EILO among adult asthmatics
Participants who are referred for an Exercise Challenge Test will perform an additional Continuous Laryngoscopy during Exercise Test with expiratory FEV1 curves and fill in the Borg scale for dyspnea Asthma Control Test EILODI questionnaire and DISCO-RC questionnaire
The hypothesis is that the prevalence will be around 15 which is higher than the prevalence of 5-8 among the general adolescent population This is based on the increased prevalence of EILO among adult asthmatics
Participants who are referred for an Exercise Challenge Test will perform an additional Continuous Laryngoscopy during Exercise Test with expiratory FEV1 curves and fill in the Borg scale for dyspnea Asthma Control Test EILODI questionnaire and DISCO-RC questionnaire
Detailed Description:
BackgroundExertional dyspnoea is a common and limiting symptom within the paediatric population Regular physical activity is paramount for the development of children since it not only promotes cardiorespiratory fitness and muscle strength but also offers opportunities for self-expression building confidence and social interaction and integration It is therefore important to identify the correct causes of exertional dyspnea and reverse them to enable children to be active without symptoms
Exercise induced bronchoconstriction EIB is a well-known cause of exertional dyspnoea and is highly specific of childhood asthma Another less recognized cause of exertional dyspnoea is exercise induced laryngeal obstruction EILO EILO is an inappropriate closure of the larynx during strenuous physical activity with no obvious laryngeal pathology at rest limiting airflow and causing inspiratory stridor It can co-exist with and mimic symptoms of EIB
Previous studies showed a prevalence of 6 in adolescent populations However recent studies revealed a much higher prevalence ofEILO in adults with asthma up to 25-47 The prevalence of EILO amongst children with asthma has not yet been investigated In this study the aim is to investigate the prevalence of EILO in children with asthma
If EILO is a significant comorbidity of childhood asthma this would implicate that EILO screening should be considered when exercise is a persistent trigger of symptoms in asthmatic children Correct EILO diagnosis and treatment can lead to adequate treatment of EILO and to prevention of overtreatment of asthma
Methods Participants who are referred for an Exercise Challenge Test will perform an additional Continuous Laryngoscopy during Exercise Test with expiratory FEV1 curves and fill in the Borg scale for dyspnea Asthma Control Test EILODI questionnaire and DISCO-RC questionnaire
Power analysis The sample size is calculated based on an estimated prevalence and confidence interval with a power of 80 and alpha of 005 When estimating a prevalence of 15 CI 10-20 which is 2 times higher than in the general population 30 this results in a sample size of 196 participants This was rounded to 200 participants Dropouts will be replaced until a total number of 200 participants completed both the ECT and CLE test
Statistical analysis for primary outcome The prevalence of EILO in the study population of adolescents with asthma will be calculated as a percentage with a 95 confidence interval Baseline characteristics will be compared between participants and non-participants of the CLE test If there are no significant differences between these groups it can be assumed that participants represent the studied population If there are significant differences in baseline characteristics we will examine the correlation of these characteristics with EILO An estimated prevalence of EILO will be calculated among the non-participants based on these correlations and an estimated weighted average will be calculated of the prevalence of EILO among the studied population
Exercise induced bronchoconstriction EIB is a well-known cause of exertional dyspnoea and is highly specific of childhood asthma Another less recognized cause of exertional dyspnoea is exercise induced laryngeal obstruction EILO EILO is an inappropriate closure of the larynx during strenuous physical activity with no obvious laryngeal pathology at rest limiting airflow and causing inspiratory stridor It can co-exist with and mimic symptoms of EIB
Previous studies showed a prevalence of 6 in adolescent populations However recent studies revealed a much higher prevalence ofEILO in adults with asthma up to 25-47 The prevalence of EILO amongst children with asthma has not yet been investigated In this study the aim is to investigate the prevalence of EILO in children with asthma
If EILO is a significant comorbidity of childhood asthma this would implicate that EILO screening should be considered when exercise is a persistent trigger of symptoms in asthmatic children Correct EILO diagnosis and treatment can lead to adequate treatment of EILO and to prevention of overtreatment of asthma
Methods Participants who are referred for an Exercise Challenge Test will perform an additional Continuous Laryngoscopy during Exercise Test with expiratory FEV1 curves and fill in the Borg scale for dyspnea Asthma Control Test EILODI questionnaire and DISCO-RC questionnaire
Power analysis The sample size is calculated based on an estimated prevalence and confidence interval with a power of 80 and alpha of 005 When estimating a prevalence of 15 CI 10-20 which is 2 times higher than in the general population 30 this results in a sample size of 196 participants This was rounded to 200 participants Dropouts will be replaced until a total number of 200 participants completed both the ECT and CLE test
Statistical analysis for primary outcome The prevalence of EILO in the study population of adolescents with asthma will be calculated as a percentage with a 95 confidence interval Baseline characteristics will be compared between participants and non-participants of the CLE test If there are no significant differences between these groups it can be assumed that participants represent the studied population If there are significant differences in baseline characteristics we will examine the correlation of these characteristics with EILO An estimated prevalence of EILO will be calculated among the non-participants based on these correlations and an estimated weighted average will be calculated of the prevalence of EILO among the studied population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None