Phase 2
N=60
Preschool Wheeze: Inflammation/Infection Guided Management
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02517099 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Number of Unscheduled Healthcare Visits (UHCV) — 0.5; 0.5 number of visits — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Beclometasone (Drug); Co-amoxiclav (Drug); Azithromycin (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Unscheduled Healthcare Visits (UHCV) |
0.5; 0.5 | 0.05 |
| SECONDARY Health Related Quality of Life |
6.7; 6.4 | — |
| SECONDARY Symptom Days |
9; 12 | — |
| SECONDARY Number of Courses of Oral Steroids |
13; 14 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02517099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.