Bacterial Lysate In Preventing Asthma

NCT05064631 | Completed Phase 2 DMC

• 2 other identifiers: 2958822021-000628-36
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 3

Brief Summary

Bronchiolitis is a common viral infection of the small airways of infants and some affected infants will require hospital admission. Severe bronchiolitis is a marker for greatly increased risk of developing both preschool wheeze and subsequent school age asthma. Since epidemiological studies suggest that exposure to microbial products protects against preschool wheeze, lysates of bacteria may prevent the development of wheeze after bronchiolitis, with long-term beneficial consequences. BLIPA is a phase 2b, randomised, double blind, placebo-controlled study, investigating the efficacy superiority of bacterial lysate (Broncho Vaxom) capsules over placebo, in reducing wheeze in infants after severe bronchiolitis. The primary end point of the study to establish whether there is superiority of oral Broncho-Vaxom over placebo in reducing the number of parent-reported wheeze episodes by 12 months post IMP/placebo initiation. The study aims to test bacterial lysate capsules (3.5mg over 12-24 months) for safety, efficacy, and to advance mechanistic understanding of its action.

Conditions

Pediatric Respiratory Diseases; Wheezing; Respiratory Tract Infections

Keywords

Asthma in childhood; Bronchiolitis; Wheeze; Bacterial lysate

Outcome Measures

Primary Outcomes (1)

• Number of a wheeze episodes by 12 months

  To establish whether there is superiority of oral Broncho-Vaxom over placebo in the reduction of parent reported wheeze episodes by 12 months post IMP/placebo initiation

  12 months

Secondary Outcomes (18)

• To establish whether there is a difference between treatment with Broncho-Vaxom or placebo in healthcare professional confirmed wheeze episodes by 12 months post IMP initiation.

  12 months

• Occurrence of hospital admissions for wheeze-related illness by 12 months.

  12 months

• Occurrence of unscheduled medical attendance for wheeze-related illness by 12 months

  12 months

• Presence of wheeze diagnosis by 12 months

  12 months

• Time to first wheeze episode by 12 months

  0-12 months

Study Arms (2)

Active intervention

EXPERIMENTAL

Oral Broncho-Vaxom (3.5mg) administered daily for 10 days per month for 12-24 months

Drug: Bacterial Lysate

Placebo control

PLACEBO COMPARATOR

Matched placebo administered daily for 10 days per month for 12-24 months

Drug: Bacterial Lysate

Interventions

Bacterial Lysate DRUG

Bacterial lysate medicines are made from bacterial cells that are broken down and are intended to stimulate the immune system.

Also known as: Broncho Vaxom

Active intervention; Placebo control

Eligibility Criteria

• Age: 2 Weeks - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parent/Guardian able to provide written informed consent
• Within 6 weeks of discharge from hospital for bronchiolitis
• Child aged ≥2 weeks and ≤12 months at the time of consent to study
• 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

You may not qualify if:

• 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 37 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.
• Currently enrolled to another Randomised Clinical Trial. (Unless prior approval is given by Principal Investigator)
• Sibling of a BLIPA participant (of the same household or family)

Sponsors & Collaborators

• Queen Mary University of London: lead
• Queensland University of Technology: collaborator

Study Sites (3)

Royal London Hospital

London, E1 1FR, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Respiratory Sounds; Bronchiolitis

Interventions

Broncho-Vaxom

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Jonathan Grigg, Prof. Dr

  Queen Mary University of London

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Parents or guardians will be blind to treatment allocation, as will the entire site study team involved in the management of the study, including the Chief Investigator (CI), PIs, sub-investigators, study nurses, and site coordinators. Trial Steering Committee (TSC) members will remain blind. The progress and safety of the study will be assessed by the Data Monitoring Committee (DMC). The DMC will therefore not be blinded. The main study trial manager (PCTU) and trial monitors will be blinded. The Sponsor's Joint Research Management Office (JRMO) including the JRMO monitor(s) will unblind themselves to specific patients in order to report SUSARs to the Medicines and Healthcare products Regulatory Agency (MHRA). The study pharmacist will be blinded, and the study pharmacy file will contain blinded documents, please see pharmacy manual. The treatment allocation list will be available from the PCTU or their designate (Sealed Envelope) on request should the need arise.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Children will be allocated into two arms (oral BV and placebo) in a 1:1 ratio. Randomisation will be stratified by site and parental asthma and the lists generated using random blocks of size 4 and 6.

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: October 1, 2021
• Study Start: January 12, 2022
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)