Actively Recruiting

Age: 1Year - 5Years
All Genders
ID06237660

Development of Non-invasive Biomarkers to Direct Individualised Management of Preschool Wheeze

Led by Imperial College London · Updated on 2024-04-29

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

I

Imperial College London

Lead Sponsor

A

Action Medical Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to find simple, non-invasive bedside tests that can help identify different types of wheezing in preschool children aged 1 to 5 years. Current treatments using inhaled steroids only work well for about 25% of these children who have allergies, so new approaches are needed. The study focuses on testing the accuracy, feasibility, and acceptability of various tests to better match treatment to each child's needs. The study involves several tests including skin prick tests for common allergies, finger prick blood tests, throat and nose swabs to detect bacteria, sputum induction after inhaling a saline mist to collect phlegm, and a lung function test called forced oscillation technique (FOT). A small group of children will also take part in a trial where their treatment is guided by these test results to see if this approach is acceptable to parents and feasible for future studies. Participants will undergo these tests and researchers will monitor their symptoms, medication use, and results from the tests over three years. The study will assess the accuracy of these tests compared to more invasive procedures like bronchoscopy, and measure how well they are accepted by children and parents. Outcome measures include lung function, inflammation markers, infection detection, and symptom control. The total study duration allows for long-term observation and evaluation of these bedside tests as potential tools for personalized treatment planning.

CONDITIONS

Brief Title

Longitudinal Preschool Wheeze Biomarker Study

Who Can Participate

Age: 1Year - 5Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 1-5 years
  • More than 2 hospitalisations for acute wheeze in the last year or at least 1 admission requiring high dependency unit or intravenous bronchodilator therapy in the last year
  • Children undergoing clinically indicated bronchoscopy as part of their standard care (for Aim 1 only)
Not Eligible

You will not qualify if you...

  • Alternative respiratory diagnosis such as cystic fibrosis or bronchiectasis

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Initial assessments at enrollment with ongoing evaluations over 3 years

Participants undergo several simple bedside tests including skin prick test, finger prick blood test, forced oscillation breathing test, oropharyngeal swab, and sputum induction to assess allergy, infection, and lung function related to preschool wheeze.

Multiple visits for tests as needed during the study period

Long-term Monitoring

Duration - Up to 3 years

Participants are monitored over a period of up to 3 years to evaluate the usefulness and acceptability of the bedside tests and to observe their wheezing symptoms and response to any treatments guided by test results.

Periodic visits throughout the study duration

Trial Site Locations

Total: 1 location

1

Royal Brompton Hospital

London, United Kingdom, SW3 6NP

Actively Recruiting

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Research Team

C

Cheuk Fung Wong

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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