BLIPA: Bacterial Lysate In Preventing Asthma

Sponsor

Barts & The London NHS Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT05710081

Collaborator

University of Aberdeen (Other), University of Edinburgh (Other), King's College London (Other), University of Southampton (Other), Menzies School of Health Research (Other)

894

Enrollment

Location

Arms

Anticipated Duration (Months)

22.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wheezing Bronchiolitis Asthma in Children	Biological: Bacterial Lysate Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

894 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 30, 2021

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Intervention

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

Biological: Bacterial Lysate

Bacterial Lysate

Placebo Comparator: Placebo

Placebo - 3.5mg granules once daily for 10 days per month for 24 months

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Difference in children between treatment with BV granules or placebo in parent-reported clinical outcome measures between 0-24 months. [24 months]
Time in days to first episode of wheeze from initiation of IMP or placebo 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 systemic corticosteroids (within the 24 months post initiation of IMP or placebo) Number of courses of oral corticosteroids for wheeze Number of courses of antibiotics This will be a combination outcome of the following factors. Prescription of regular oral montelukast (yes/no)
Assess compliance with the medications [24 months]
Combination outcome combining the following. Compliance with medication assessed from monthly questionnaires completed by parents and guardians. The effect of oral BV on parent-reported, healthcare-professional confirmed wheeze in the stratum of patients that have met compliance as defined as 80% of capsules taken across the whole 24 months.
Parents and healthcare professionals' self-assessment of blinding [24 months]
Parent prediction: BV or placebo Healthcare professional prediction: BV or placebo
Markers of atopy and BV function [24 months]
Blood serum total and specific IgE and blood eosinophil

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Weeks to 12 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)