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Bacterial Lysate In Preventing Asthma (BLIPA)

Primary Purpose

Wheezing, Bronchiolitis, Asthma in Children

Status
Recruiting
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Bacterial Lysate
Placebo
Sponsored by
Barts & The London NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wheezing focused on measuring bacterial lysate, placebo, wheeze, allergy, asthma

Eligibility Criteria

2 Weeks - 12 Months (Child)All SexesDoes not accept 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)

Sites / Locations

  • Barts Health NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Use of medication
Prescription for more than one salbutamol inhaler
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
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
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
Montelukast use
Prescription of regular oral montelukast (yes/no)
Number of courses of antibiotics
Number of courses of antibiotics
Eczema diagnosis
Eczema (yes/no) Eczema confirmed by U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis.
Safety and Tolerability
Number of AE/SAE/SUSAR events across 0-24 months and 19-24 months

Full Information

First Posted
December 2, 2022
Last Updated
March 22, 2023
Sponsor
Barts & The London NHS Trust
Collaborators
University of Aberdeen, University of Edinburgh, King's College London, University of Southampton, Menzies School of Health Research
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1. Study Identification

Unique Protocol Identification Number
NCT05710081
Brief Title
Bacterial Lysate In Preventing Asthma
Acronym
BLIPA
Official Title
Oral Bacterial Lysate to Prevent Persistent Wheeze in Infants After Severe Bronchiolitis; a Randomised Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barts & The London NHS Trust
Collaborators
University of Aberdeen, University of Edinburgh, King's College London, University of Southampton, Menzies School of Health Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wheezing, Bronchiolitis, Asthma in Children
Keywords
bacterial lysate, placebo, wheeze, allergy, asthma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
894 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Bacterial Lysate - Broncho-Vaxom (OM-85) 3.5mg granules once daily for 10 days per month for 24 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo - 3.5mg granules once daily for 10 days per month for 24 months
Intervention Type
Biological
Intervention Name(s)
Bacterial Lysate
Intervention Description
Bacterial Lysate
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Occurrence of parent-reported, healthcare professional-confirmed wheeze between 19 and 24 months after initiation of IMP or placebo.
Description
Occurrence of parent-reported, healthcare professional-confirmed wheeze between 19 and 24 months after initiation of IMP or placebo.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Use of medication
Description
Prescription for more than one salbutamol inhaler
Time Frame
24 months
Title
Asthma or Wheeze Diagnosis
Description
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
Time Frame
24 months
Title
Unscheduled Medical attendances
Description
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
Time Frame
24 months
Title
Number of courses of oral steroids
Description
Number of courses of systemic corticosteroids (within the 24 months post initiation of IMP or placebo) Number of courses of oral corticosteroids for wheeze
Time Frame
24 months
Title
Montelukast use
Description
Prescription of regular oral montelukast (yes/no)
Time Frame
24 months
Title
Number of courses of antibiotics
Description
Number of courses of antibiotics
Time Frame
24 months
Title
Eczema diagnosis
Description
Eczema (yes/no) Eczema confirmed by U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis.
Time Frame
24 months
Title
Safety and Tolerability
Description
Number of AE/SAE/SUSAR events across 0-24 months and 19-24 months
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Difference in children between treatment with BV granules or placebo in parent-reported clinical outcome measures between 0-24 months.
Description
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)
Time Frame
24 months
Title
Assess compliance with the medications
Description
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.
Time Frame
24 months
Title
Parents and healthcare professionals' self-assessment of blinding
Description
Parent prediction: BV or placebo Healthcare professional prediction: BV or placebo
Time Frame
24 months
Title
Markers of atopy and BV function
Description
Blood serum total and specific IgE and blood eosinophil
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Thomson
Phone
07919 659975
Email
blipa@qmul.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel Adewunmi
Phone
07919 659975
Email
blipa@qmul.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Grigg
Organizational Affiliation
Barts & The London NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barts Health NHS Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wahida Kayyum
Email
wahida.kayyum@nhs.net
First Name & Middle Initial & Last Name & Degree
Abigail Whitehouse
Email
a.whitehouse@qmul.ac.uk
First Name & Middle Initial & Last Name & Degree
Jonathan Grigg
First Name & Middle Initial & Last Name & Degree
Abigail Whitehouse

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This will be discussed at TSC and changed if felt approapriate

Learn more about this trial

Bacterial Lysate In Preventing Asthma

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