Preschool Wheeze: Inflammation/Infection Guided Management

NCT02517099 | Completed Phase 2 Results

• 1 other identifier: 165460
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Asthma

Keywords

Preschool; Wheeze; Moderate; Severe

Outcome Measures

Primary Outcomes (1)

• Number of Unscheduled Healthcare Visits (UHCV)

  Actual number of unscheduled healthcare visits (UHCV) includes GP, A\&E or hospital admission. This is median number of visits in 4 months - with range.

  4 months

Secondary Outcomes (3)

• Health Related Quality of Life

  4 months

• Symptom Days

  4 months

• Number of Courses of Oral Steroids

  4 months and up to 1 year later

Study Arms (2)

Pathological phenotype

ACTIVE COMPARATOR

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

Drug: Beclometasone; Drug: Co-amoxiclav; Drug: Azithromycin

Clinical guidelines

ACTIVE COMPARATOR

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

Drug: Beclometasone; Drug: Co-amoxiclav; Drug: Azithromycin

Interventions

Beclometasone DRUG

Beclometasone dipropionate 200mcg bd for 4 months

Also known as: Clenil

Clinical guidelines; Pathological phenotype

Co-amoxiclav DRUG

Co-amoxiclav 0.3ml/kg bd for 4 weeks

Also known as: Augmentin Duo

Clinical guidelines; Pathological phenotype

Azithromycin DRUG

Azithromycin 10mg/kg od for 4 weeks

Also known as: Zithromax

Clinical guidelines; Pathological phenotype

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Related Publications (1)

• Undela 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 DERIVED

MeSH Terms

Conditions

Asthma; Respiratory Sounds; Lymphoma, Follicular

Interventions

Beclomethasone; Amoxicillin-Potassium Clavulanate Combination; Azithromycin

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Erythromycin; Macrolides; Polyketides; Lactones

Results Point of Contact

• Title: Professor Sejal Saglani
• Organization: Imperial College London

s.saglani@imperial.ac.uk

02075943167

Study Officials

• Sejal Saglani

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 6, 2015
• Study Start: June 5, 2015
• Primary Completion: August 17, 2018
• Study Completion: August 17, 2018
• Last Updated: March 6, 2023
• Results First Posted: March 6, 2023

Record last verified: 2022-05

Locations

GB (1)