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Preschool Wheeze: Inflammation/Infection Guided Management

NCT02517099 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-03-06

Study results available
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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.

Conditions

Interventions

DRUG

Beclometasone

Beclometasone dipropionate 200mcg bd for 4 months

DRUG

Co-amoxiclav

Co-amoxiclav 0.3ml/kg bd for 4 weeks

DRUG

Azithromycin

Azithromycin 10mg/kg od for 4 weeks

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Imperial College London

    lead OTHER

Principal Investigators

  • Sejal Saglani · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-05
Primary Completion
2018-08-17
Completion
2018-08-17

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02517099 on ClinicalTrials.gov