# Improving the management and outcomes of preschool wheeze: protocol of a prospective multicentre cohort study

## TL;DR

This study aims to improve asthma diagnosis in preschool children by using a digital device called WheezeScan to objectively detect wheezing and its response to treatment.

## Contribution

The study introduces WheezeScan as a novel tool to objectively assess wheeze and its reversibility in preschool children, potentially improving asthma diagnosis and management.

## Key findings

- Using WheezeScan may increase definitive asthma diagnoses in preschool children.
- The study will assess if WheezeScan improves quality of life without increasing healthcare costs.

## Abstract

Preschool wheeze and asthma are associated with substantial morbidity and impaired future lung function. Yet, wheeze is unreliably reported with high disagreement (>50%) between parental and physician observations. Objectively defining wheeze and its reversibility could enable an earlier asthma diagnosis and improve preschool wheeze management.

Our primary aim is to determine in preschool children (aged 0.5–6 years) suspected of asthma whether adding WheezeScan to routine clinical assessment (vs assessment without WheezeScan) improves the diagnosis of asthma. Our primary hypothesis is that using WheezeScan in preschool children suspected of asthma is associated with increased definitive asthma diagnoses in this age group. Our secondary aims are to (a) examine the effect of using WheezeScan on patient-reported outcomes (PROs) and (b) healthcare costs. Our secondary hypothesis is that using WheezeScan in preschool children suspected of asthma is associated with improved quality of life without incurring additional healthcare costs.

Our multicentre prospective cohort study involves recruiting 102 preschool children suspected of asthma. WheezeScan, a user-friendly digital device, incorporates artificial intelligence to objectively define wheeze and its response to bronchodilators. Over 6 weeks, parents/caregivers use the WheezeScan two times per day and whenever wheezing is suspected. If wheeze is detected, an inhaled short-acting β2-agonist is administered and WheezeScan determines if wheeze resolves thereafter.

Our primary endpoint is the proportion of children with a definitive asthma diagnosis, compared with baseline, based on the treating clinician’s assessment using WheezeScan data. Our secondary outcomes are PROs, reflecting generic health-related quality-of-life and cough-specific (if chronic cough present) outcomes and health costs.

The Children’s Health Queensland Human Research Ethics Committee (HREC/23/QCHQ/100691) and the Queensland University of Technology Office of Research Ethics and Integrity approved the study. We will publish and share results with the academic and healthcare communities and relevant patient organisations.

Australian New Zealand Clinical Trials Registry ACTRN12623000904673.