Clinical trial · Interventional
Preschool Wheeze: Inflammation/Infection Guided Management
Use of Pathological Phenotype to Determine Optimal Management for Moderate to Severe Preschool Wheeze
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Asthma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azithromycin | Drug | — | UNRESOLVED |
| Beclometasone | Drug | — | UNRESOLVED |
| Co-amoxiclav | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Pathological phenotype
- description
- Regular inhaled steroids- Beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co- amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
- interventionNames
- Drug: Beclometasone
- Drug: Co-amoxiclav
- Drug: Azithromycin
- type
- ACTIVE_COMPARATOR
- label
- Clinical guidelines
- description
- The children will be treated as directed by their Consultant Paediatrician. The treatment may include- regular inhaled steroids- beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co-amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
- interventionNames
- Drug: Beclometasone
- Drug: Co-amoxiclav
- Drug: Azithromycin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 5 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDUndela K, Goldsmith L, Kew KM, Ferrara G. Macrolides versus placebo for chronic asthma. Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD002997. doi: 10.1002/14651858.CD002997.pub5. PMID 34807989