Preschool Wheeze: Inflammation/Infection Guided Management

• Status: Completed
• Trial end date: 2018-08-17
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-centre, randomised-controlled trial, comparing management of preschool wheeze. It specifically aims to compare management of preschool wheeze using current clinical guidelines to management determined by eosinophilic inflammation and infection. Participants will be children aged 1-5 years who have recurrent wheezing and will be allocated to one of two treatment groups, either current clinical care or pathological phenotype based management. They will be asked to make 2 study visits to the Royal Brompton Hospital over the course of 4 months.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Collaborator: National Institute for Health Research, United Kingdom
• Treatments: Amoxicillin-Potassium Clavulanate Combination; Azithromycin; Beclomethasone

Criteria

Inclusion Criteria:

• Reported recurrent wheeze, needing at least 2 courses of oral steroids in the last 12 months, at least one course of oral steroids in the last 6 months

• Past wheeze confirmed by a clinician

Exclusion Criteria:

• Any known cardiac disease

• Any chronic respiratory condition (other than preschool wheeze) diagnosed by a physician

• Any chronic condition that increases susceptibility to respiratory tract infections such as severe developmental delay and feeding difficulty/unsafe swallow Prematurity <34 weeks, or requirement of ventilation in the newborn period History of neonatal chronic lung disease Family not contactable by telephone