Bacterial Lysate In Preventing Asthma

Phase 3

Recruiting

• Conditions: Wheezing; Bronchiolitis; Asthma in Children
• Interventions: Biological: Bacterial Lysate; Drug: Placebo

• Registration Number: NCT05710081
• Lead Sponsor: Barts & The London NHS Trust

Brief Summary

The goal of this clinical trial is to learn about the effects of using bacterial lysate in bronchiolitis. The main question it aims to answer are:

Does the use of bacterial lysate after bronchiolitis reduce the likelihood of preschool wheeze

Participants will take either the active medicine or a placebo for 24 months.

Detailed Description

To establish whether there is superiority of oral BV (broncho vaxom) over placebo in the prevention of parent-reported, healthcare professional-confirmed, persistent wheeze between 19 and 24 months post initiation of IMP/placebo, after a hospital admission for severe bronchiolitis.

Study Timeline

• Study Start: 2021-11-30
• Status Verified: 2022-12
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-02-02
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 894

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Bacterial Lysate	Bacterial Lysate - Broncho-Vaxom (OM-85) 3.5mg granules once daily for 10 days per month for 24 months
Placebo	Placebo	Placebo - 3.5mg granules once daily for 10 days per month for 24 months

Primary Outcome Measures

Name	Time	Method
Occurrence of parent-reported, healthcare professional-confirmed wheeze between 19 and 24 months after initiation of IMP or placebo.	24 months	Occurrence of parent-reported, healthcare professional-confirmed wheeze between 19 and 24 months after initiation of IMP or placebo.

Secondary Outcome Measures

Name	Time	Method
Use of medication	24 months	Prescription for more than one salbutamol inhaler
Asthma or Wheeze Diagnosis	24 months	Active wheeze diagnosis on primary care record Asthma diagnosis on primary care record Parental report of wheeze episode - time in days to first episode of wheeze from initiation of IMP or placebo
Unscheduled Medical attendances	24 months	Number of unscheduled medical attendances for wheeze Number of hospital admissions for wheeze Number of days admitted to hospital for wheeze Number of unscheduled medical attendances for any lower respiratory symptoms
Number of courses of oral steroids	24 months	Number of courses of systemic corticosteroids (within the 24 months post initiation of IMP or placebo) Number of courses of oral corticosteroids for wheeze
Montelukast use	24 months	Prescription of regular oral montelukast (yes/no)
Number of courses of antibiotics	24 months	Number of courses of antibiotics
Eczema diagnosis	24 months	Eczema (yes/no) Eczema confirmed by U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis.
Safety and Tolerability	24 months	Number of AE/SAE/SUSAR events across 0-24 months and 19-24 months

Trial Locations

Locations (1)

Barts Health NHS Trust; 🇬🇧 London, United Kingdom