Respiratory Tract Infections Clinical Trial
— BLIPAOfficial title:
Oral Bacterial Lysate to Prevent Persistent Wheeze in Infants After Severe Bronchiolitis; a Randomised Placebo-controlled Trial
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.
Status | Recruiting |
Enrollment | 894 |
Est. completion date | October 30, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 12 Months |
Eligibility | 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 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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College Hospital NHS Foundation Trust | London | |
United Kingdom | Royal London Hospital | London | |
United Kingdom | University Hospital Southampton NHS Foundation Trust | Southampton |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London | Queensland University of Technology |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of a wheezing episode between 19 and 24 months | Parent or guardian reported wheeze between 19-24 months that is also confirmed by the presence of one or more of the following in the primary care record: salbutamol inhaler, active wheeze diagnosis, asthma diagnosis. | 19-24 months | |
Secondary | Prescription for more than one salbutamol inhaler between 19-24 months | Number of prescriptions for salbutamol inhalers as recorded on the primary care record between 19-24 months | 19-24 months | |
Secondary | Active wheeze diagnosis on primary care record between 19-24 months | Presence of an active wheeze diagnosis as recorded on the primary care record between 19-24 months | 19-24 months | |
Secondary | Asthma diagnosis on primary care record between 19-24 months | Presence of an asthma diagnosis as recorded on the primary care record between 19-24 months | 19-24 months | |
Secondary | Time to first episode of parent-reported wheeze during the 24 months since initiation of study drug | The time to first episode of parent-reported wheeze during the 24 months since initiation of study drug | 0-24 months | |
Secondary | Number of unscheduled medical attendances for wheeze between 19-24 months. | Number of unscheduled medical attendances for wheeze between 19-24 months. | 19-24 months | |
Secondary | Number of hospital admissions for wheeze between 19-24 months. | Number of hospital admissions for wheeze between 19-24 months. | 19-24 months | |
Secondary | Number of days admitted to hospital for wheeze between 19-24 months. | Number of days admitted to hospital for wheeze between 19-24 months. | 19-24 months | |
Secondary | Number of unscheduled medical attendances for any lower respiratory symptoms between 19-24 months. | Number of unscheduled medical attendances for any lower respiratory symptoms between 19-24 months. | 19-24 months | |
Secondary | Number of courses of systemic corticosteroids for wheeze during the 24 months since initiation of study drug | Number of courses of systemic corticosteroids for wheeze during the 24 months since initiation of study drug | 0-24 months | |
Secondary | Number of courses of oral corticosteroids for wheeze between 19-24 months | Number of courses of oral corticosteroids for wheeze between 19-24 months | 19-24 months | |
Secondary | Number of courses of antibiotics for wheeze between 19-24 months | Number of courses of antibiotics for wheeze between 19-24 months | 19-24 months | |
Secondary | Prescription for regular oral montelukast between 19-24 months | Presence of a prescription for regular oral montelukast recorded in the primary care record between 19-24 months. | 19-24 months | |
Secondary | Presence of eczema between 19-24 months | Presence of eczema between 19-24 months confirmed by parent report at study follow ups (parent reported outcome) | 19-24 months | |
Secondary | Eczema confirmed by U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis. at 19-24 months. | Presence of Eczema confirmed by U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis. between 19-24 months. | 19-24 months | |
Secondary | Incidence of adverse events (AEs) for the treatment group between 0-24 months | Number of AEs across 0-24 months | 0-24 months | |
Secondary | Incidence of serious adverse events (SAEs) for the treatment group between 0-24 months | Number of SAEs across 0-24 months | 0-24 months | |
Secondary | Incidence of Suspected unexpected serious adverse reactions (SUSARs) for the treatment group between 0-24 months | Number of SUSARs across 0-24 months | 0-24 months | |
Secondary | Incidence of adverse events (AEs) for the treatment group between 19-24 months | Number of AEs across 19-24 months | 19-24 months | |
Secondary | Incidence of serious adverse events (SAEs) for the treatment group between 19-24 months | Number of SAEs across 19-24 months | 19-24 months | |
Secondary | Incidence of Suspected unexpected serious adverse reactions (SUSARs) for the treatment group between 19-24 months | Number of SUSARs across 19-24 months | 19-24 months |
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