Bacterial Lysate In Preventing Asthma (BLIPA)

Barts & The London NHS Trust

Status and phase: Enrolling; Phase 3

Conditions: Wheezing; Bronchiolitis; Asthma in Children

Treatments: Biological: Bacterial Lysate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05710081

295882

2021-000628-36 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 894 estimated patients

Sex: All

Ages: 2 weeks to 12 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

1. Parent/Guardian able to provide written informed consent
2. Within 6 weeks of discharge from hospital following admission for bronchiolitis
3. Child aged is ≥2 weeks of age and ≤ 12 months on the date of hospital admission for Bronchiolitis
4. A diagnosis of Bronchiolitis requiring a hospital admission (defined as more than 4 hours in hospital)
5. Contactable for regular follow up by the research team

EXCLUSION CRITERIA

1. Any previous hospital attendance for bronchiolitis
2. More than one episode of healthcare professional-diagnosed wheeze prior to index bronchiolitis episode
3. Premature gestational age less than 34 weeks
4. 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.
5. History of clinically significant neonatal disease (e.g. neonatal pneumonia, congenital lung abnormality, neonatal chronic lung disease)
6. Genetic conditions that affect the immune system (e.g. Down's syndrome/Trisomy 21)
7. Current regular oral montelukast or inhaled corticosteroid therapy or inhaled salbutamol therapy
8. Current regular treatment with immunomodulatory drugs (e.g oral steroids)
9. Known allergy or previous intolerance to study medication.
10. Enrolment in another clinical trial of a medicinal product. Non-CTIMP study participation is allowed.
11. Sibling of a BLIPA participant (of the same household or family)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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894 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

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

Treatment:

Biological: Bacterial Lysate

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo