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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05064631




Registration number
NCT05064631
Ethics application status
Date submitted
20/08/2021
Date registered
1/10/2021
Date last updated
3/08/2023

Titles & IDs
Public title
Bacterial Lysate In Preventing Asthma
Scientific title
Oral Bacterial Lysate to Prevent Persistent Wheeze in Infants After Severe Bronchiolitis; a Randomised Placebo-controlled Trial
Secondary ID [1] 0 0
2021-000628-36
Secondary ID [2] 0 0
295882
Universal Trial Number (UTN)
Trial acronym
BLIPA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Tract Infections 0 0
Pediatric Respiratory Diseases 0 0
Wheezing 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bacterial Lysate

Experimental: Active intervention - Oral Broncho-Vaxom (3.5mg) administered daily for 10 days per month for 24 months

Placebo Comparator: Placebo control - Matched placebo administered daily for 10 days per month for 24 months


Treatment: Drugs: Bacterial Lysate
Bacterial lysate medicines are made from bacterial cells that are broken down and are intended to stimulate the immune system.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of a wheezing episode between 19 and 24 months
Timepoint [1] 0 0
19-24 months
Secondary outcome [1] 0 0
Prescription for more than one salbutamol inhaler between 19-24 months
Timepoint [1] 0 0
19-24 months
Secondary outcome [2] 0 0
Active wheeze diagnosis on primary care record between 19-24 months
Timepoint [2] 0 0
19-24 months
Secondary outcome [3] 0 0
Asthma diagnosis on primary care record between 19-24 months
Timepoint [3] 0 0
19-24 months
Secondary outcome [4] 0 0
Time to first episode of parent-reported wheeze during the 24 months since initiation of study drug
Timepoint [4] 0 0
0-24 months
Secondary outcome [5] 0 0
Number of unscheduled medical attendances for wheeze between 19-24 months.
Timepoint [5] 0 0
19-24 months
Secondary outcome [6] 0 0
Number of hospital admissions for wheeze between 19-24 months.
Timepoint [6] 0 0
19-24 months
Secondary outcome [7] 0 0
Number of days admitted to hospital for wheeze between 19-24 months.
Timepoint [7] 0 0
19-24 months
Secondary outcome [8] 0 0
Number of unscheduled medical attendances for any lower respiratory symptoms between 19-24 months.
Timepoint [8] 0 0
19-24 months
Secondary outcome [9] 0 0
Number of courses of systemic corticosteroids for wheeze during the 24 months since initiation of study drug
Timepoint [9] 0 0
0-24 months
Secondary outcome [10] 0 0
Number of courses of oral corticosteroids for wheeze between 19-24 months
Timepoint [10] 0 0
19-24 months
Secondary outcome [11] 0 0
Number of courses of antibiotics for wheeze between 19-24 months
Timepoint [11] 0 0
19-24 months
Secondary outcome [12] 0 0
Prescription for regular oral montelukast between 19-24 months
Timepoint [12] 0 0
19-24 months
Secondary outcome [13] 0 0
Presence of eczema between 19-24 months
Timepoint [13] 0 0
19-24 months
Secondary outcome [14] 0 0
Eczema confirmed by U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis. at 19-24 months.
Timepoint [14] 0 0
19-24 months
Secondary outcome [15] 0 0
Incidence of adverse events (AEs) for the treatment group between 0-24 months
Timepoint [15] 0 0
0-24 months
Secondary outcome [16] 0 0
Incidence of serious adverse events (SAEs) for the treatment group between 0-24 months
Timepoint [16] 0 0
0-24 months
Secondary outcome [17] 0 0
Incidence of Suspected unexpected serious adverse reactions (SUSARs) for the treatment group between 0-24 months
Timepoint [17] 0 0
0-24 months
Secondary outcome [18] 0 0
Incidence of adverse events (AEs) for the treatment group between 19-24 months
Timepoint [18] 0 0
19-24 months
Secondary outcome [19] 0 0
Incidence of serious adverse events (SAEs) for the treatment group between 19-24 months
Timepoint [19] 0 0
19-24 months
Secondary outcome [20] 0 0
Incidence of Suspected unexpected serious adverse reactions (SUSARs) for the treatment group between 19-24 months
Timepoint [20] 0 0
19-24 months

Eligibility
Key inclusion criteria
- Parent/Guardian able to provide written informed consent

- Within 6 weeks of discharge from hospital for bronchiolitis

- Child aged 3-12 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
Minimum age
3 Months
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2025
Actual
Sample size
Target
894
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
London
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Other
Name
Queen Mary University of London
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Queensland University of Technology
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 is
parent-reported, healthcare-professional confirmed wheeze at 19-24 months. The study aims to
test bacterial lysate capsules (3.5mg over 24 months) for safety, efficacy, and to advance
mechanistic understanding of its action.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05064631
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Jonathan Grigg, Prof. Dr
Address 0 0
Queen Mary University of London
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jonathan Grigg, Prof. Dr
Address 0 0
Country 0 0
Phone 0 0
00447789397850
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05064631