Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05447832 |
| Other study ID # |
307300 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 2022 |
| Est. completion date |
March 29, 2024 |
Study information
| Verified date |
July 2022 |
| Source |
Imperial College London |
| Contact |
Sejal Saglani, MD |
| Phone |
+442075943167 |
| Email |
s.saglani[@]imperial.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of this project is to fill the significant unmet healthcare need to prevent wheeze
attacks in preschool children. This will be achieved by developing a proof-of-concept,
bespoke home remote objective monitoring system for preschool children that can identify
early signs before a wheeze attack to allow early intervention and prevention. This study
aims to develop methods for recognising child-specific abnormal patterns in time-course lung
function data, and wheeze onset providing early warning of deterioration. The prototype
system is targeted for use by caregivers of preschool children with wheeze, and will
integrate the individual child's information about symptoms, medication use and lung function
to alert parents to seek healthcare advice to prevent hospitalisation.
Description:
Asthma is the most common childhood non-infectious lung disease in the United Kingdom,
affecting ~8% of children. Asthma symptoms include wheezing (a high-pitched whistling sound
created by turbulent airflow through narrowed airways) associated with difficulty in
breathing and shortness of breath, often with a dry cough. Asthma is characterised by
episodic (wheeze attacks) and variable symptoms which fluctuate day-to-day. An asthma, or
wheeze attack, is a sudden worsening of symptoms, associated with airway obstruction that
requires treatment to open up the airways.
Preschool children (aged 1-5 years) account for the majority (75%) of hospital admissions for
acute attacks of wheezing in the UK. Up to half of all preschool children will suffer at
least one episode of wheezing by their 6th birthday, and 7.8% of preschool children came to
primary care with acute wheezing in 2017 in the UK. Frequent severe wheeze attacks in
preschool age are the strongest risk factor for diminished lung function at physiological
peak in early adulthood and are associated with chronic obstructive pulmonary disease (COPD)
in the sixth decade of life, as well as early all-cause mortality and cardiovascular and
metabolic comorbidities. It is therefore vital to prevent wheeze attacks in preschool
children.
Preschool children experience a 5-times higher rate of hospitalisation for acute wheeze
attacks compared to school-aged children. This suggests overt symptoms present late, and not
soon enough, for early intervention to prevent attacks in preschool children. The number of
unscheduled healthcare presentations of acute wheeze attacks has not decreased for the last 2
decades for preschool children, while it has been declining for school-aged children and
adults, resulting in a high socioeconomic burden in the UK and worldwide.
Failure to prevent wheeze attacks in preschool children is in part due to the absence of
age-specific remote and objective monitoring technology for disease severity. Currently, in
this age group, symptoms are diagnosed and monitored by subjective assessments of airway
obstruction (narrowing). Evidence that the symptoms improve following treatment with inhaled
bronchodilators is used as an indirect indication of the presence of reversible airway
obstruction, which is a cardinal feature of asthma. In school-aged children and adults,
airway obstruction is monitored objectively with lung function tests such as spirometry.
Spirometry can be performed remotely at home to aid telemedicine monitoring in asthma.
However, spirometry requires a forced expiratory manoeuvre and cooperation from the patient.
It can thus only be reliably performed in children over 5 years old. As a result, diagnosis
and monitoring of wheezing/asthma in preschool children depends on parental reports, clinical
examination and subjective assessment of symptoms, but no objective measures of airway
obstruction.
For this study, time-course lung function data will be obtained using a novel home-based
wearable device designed for preschool children that detects airway obstruction whilst the
child is asleep (Ventica®). Also, eliciting objective confirmation of wheeze will be obtained
by the use of the WheezeScan® device, which detects presence/absence of wheeze when placed on
the child's chest. This information will contribute to developing an app that combines
symptoms, medication use, and lung function to allow wheeze detection and provide a
personalised plan for parents to seek healthcare advice.
STUDY HYPOTHESES
1. A mobile-based system integrating data on remote lung function, symptoms and medication
use can be used to predict the development of an acute attack of wheeze in children aged
1-5 years.
2. The dynamic change in lung function reflects underlying airway pathology in severe
wheezing
STUDY OBJECTIVES
1. To develop a mobile app system that collects data on lung function, symptoms and
medication use, and returns personalised prediction for preschool wheezers, empowering
parents to self-manage their child's wheeze/asthma.
2. To quantify airway inflammation and remodelling in endobronchial biopsies and
broncho-alveolar lavage from a subgroup of preschool children with severe wheezing and
relate pathology to the pattern of airway obstruction detected using the Ventica®
system.
3. To develop prediction models that integrate patient-specific abnormal patterns in
time-course lung function data, symptoms recorded using with and without WheezeScan®,
and rescue medication use, providing early warning of deterioration.
