Our primary objective is to determine the prevalence of exercise induced laryngeal obstruction (EILO) in children with asthma. As secondary objectives, we aim to investigate 1) if there is a different prevalence of EILO in children with and without…
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The presence of EILO based on the Maat score (glottic and/or supraglottic,
grade 2 or higher) during the CLE test
Secondary outcome
-Recognizable symptoms induced : yes/no
-EILO grade score (Maat score; glottic and/or supraglottic)
-Laryngeal pathology at rest
-Exercise induced bronchoconstriction defined as post-exercise fall in FEV1 >
10% during CLE test and during ECT beforehand. (Post-exercise fall in FEV1 =
(FEV1pre-exercise - FEV1post-exercise) / FEV1pre-exercise * 100%).
-Symptoms reported
-Test duration and duration until start of symptoms and until peak dyspnea
-Heart rate during exercise
-Lung function with in- and expiratory flow volume loops (FEV1, FEV1(%pred),
FVC)
-before exercise
-after exercise at 2 minute intervals (1,3,6 minutes)
-Maximum running pace and slope (or max Wattage and Wattage/kg )
-ACT score and sub scores
-EILODI score and sub scores
-VAS score: before exercise, at peak level of dyspnea and 2 minutes after
exercise
Background summary
Exertional dyspnoea is a common and limiting symptom within the paediatric
population. Exercise induced bronchoconstriction (EIB) is a well-known cause of
exertional dyspnoea and is highly specific of childhood asthma (5). Another
less recognized cause of exertional dyspnoea is exercise induced laryngeal
obstruction (EILO) (10). It can co-exist with and mimic symptoms of EIB (10).
EILO can be diagnosed by continuous laryngoscopy during exercise (CLE) (11).
EILO prevalence seemed markedly higher in adults with asthma: up to 25-47%,
compared to 8% in the general population. The prevalence of EILO amongst
children with asthma has not yet been investigated. 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. We therefore aim to investigate the prevalence of EILO in children
with asthma.
Study objective
Our primary objective is to determine the prevalence of exercise induced
laryngeal obstruction (EILO) in children with asthma. As secondary objectives,
we aim to investigate 1) if there is a different prevalence of EILO in children
with and without EIB, 2) if there are baseline or test characteristics
associated with the presence of EILO in asthmatic children, 3) if questionnaire
scores (ACT, EILODI and/or VAS) are associated with the presence of EILO in
asthmatic children, 4) if lung function measurements (LF) with a standardized
CLE test protocol are similar to LF measurements with a standardized ECT
protocol and 5) the inter-rater reliability of EILO diagnosis between both
hospitals based on the video-images of the larynx during exercise
Study design
This study has a cross-sectional design. Asthmatic children perform an Exercise
Challenge Test (ECT) and Continuous Laryngoscopy during Exercise Test (CLE
test).
Intervention
Continuous laryngoscopy during exercise
Study burden and risks
The burden of participating in this study involves a CLE test. Introduction of
the laryngoscope can be unpleasant. Therefore an anaestethic is applied to the
nostrils beforehand. The test takes about one hour and risks are minimal.
Patients will be asked to fill in two questionnaire during their visit, and a
VAS score before exercise, at peak intensity and 2 minutes after exercise.
A benefit of participating is chance to become aware of having EILO in addition
to asthma. Appropriate therapy by a speech therapist can then be started. Risks
associated with this study are deemed to be low.
Koningsstraat 1
Enschede 7512KZ
NL
Koningsstraat 1
Enschede 7512KZ
NL
Listed location countries
Age
Inclusion criteria
-Age 8 to 18 years old
-Outpatient at Medisch Spectrum Twente or Haukeland University Hospital
-History of paediatrician diagnosed asthma confirmed with objective lung
function measurements:
-a positive test for exercise induced bronchoconstriction (post-exercise fall
in FEV1 > 10% after exercise challenge test) OR
-a positive methacholine test (PC20 value of <=8 mg/mL) OR
-bronchodilator reversibility (increase in FEV1 >=12% and/or >=200 mL following
inhalation of 400 µg SABA )
Exclusion criteria
-Other severe cardiopulmonary disease than asthma
-Inability to perform exercise test and/or technical acceptable spirometry
-Current asthma exacerbation, or exacerbation in the previous 2 weeks
-Respiratory tract infection in the previous 2 weeks
-Use of LABA or SABA less than 8 hours prior to exercise challenge test
-Use of oral corticosteroids in 4 weeks prior to exercise challenge test
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84027.000.23 |