Bacterial Lysate In Preventing Asthma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oral Bacterial Lysate to Prevent Persistent Wheeze in Infants After Severe Bronchiolitis; a Randomised Placebo-controlled Trial

Conditions
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Wheezing, Bronchiolitis, Asthma in Children

Intervention / Treatment
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* Biological: Bacterial Lysate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Parent/Guardian able to provide written informed consent Within 6 weeks of discharge from hospital following admission for bronchiolitis Child aged is ≥2 weeks of age and ≤ 12 months on the date of hospital admission for Bronchiolitis A diagnosis of Bronchiolitis requiring a hospital admission (defined as more than 4 hours in hospital) Contactable for regular follow up by the research team EXCLUSION CRITERIA Any previous hospital attendance for bronchiolitis More than one episode of healthcare professional-diagnosed wheeze prior to index bronchiolitis episode Premature gestational age less than 34 weeks Any severe chronic condition such as cystic fibrosis, sickle cell disease, severe developmental delay, immunodeficiency, or anything that has a significant impact on the respiratory tract (such as need for non-invasive ventilation) or increases vulnerability to respiratory tract infections. History of clinically significant neonatal disease (e.g. neonatal pneumonia, congenital lung abnormality, neonatal chronic lung disease) Genetic conditions that affect the immune system (e.g. Down's syndrome/Trisomy 21) Current regular oral montelukast or inhaled corticosteroid therapy or inhaled salbutamol therapy Current regular treatment with immunomodulatory drugs (e.g oral steroids) Known allergy or previous intolerance to study medication. Enrolment in another clinical trial of a medicinal product. Non-CTIMP study participation is allowed. Sibling of a BLIPA participant (of the same household or family)

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Bacterial Lysate - Broncho-Vaxom (OM-85) 3.5mg granules once daily for 10 days per month for 24 months | Biological: Bacterial Lysate<br>* Bacterial Lysate<br>|
| Placebo Comparator: Placebo<br>Placebo - 3.5mg granules once daily for 10 days per month for 24 months | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of parent-reported, healthcare professional-confirmed wheeze between 19 and 24 months after initiation of IMP or placebo. | Occurrence of parent-reported, healthcare professional-confirmed wheeze between 19 and 24 months after initiation of IMP or placebo. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of medication | Prescription for more than one salbutamol inhaler | 24 months | 
| Asthma or Wheeze Diagnosis | 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 | 24 months | 
| Unscheduled Medical attendances | 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 | 24 months | 
| Number of courses of oral steroids | Number of courses of systemic corticosteroids (within the 24 months post initiation of IMP or placebo) Number of courses of oral corticosteroids for wheeze | 24 months | 
| Montelukast use | Prescription of regular oral montelukast (yes/no) | 24 months | 
| Number of courses of antibiotics | Number of courses of antibiotics | 24 months | 
| Eczema diagnosis | Eczema (yes/no) Eczema confirmed by U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis. | 24 months | 
| Safety and Tolerability | Number of AE/SAE/SUSAR events across 0-24 months and 19-24 months | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bacterial lysate, placebo, wheeze, allergy, asthma