None listed
Conditions
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 IIb, 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 rate of parent-reported wheeze episodes. 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.
Interventions
Treatment: Drugs - Bacterial Lysate. Bacterial lysate medicines are made from bacterial cells that are broken down and are intended to stimulate the immune system.
Experimental: Active intervention - Oral Broncho-Vaxom (3.5mg) administered daily for 10 (preferably consecutive) days per month for up to 24 months as oral powder mixed with food.
Adherence monitored through dosing diary and to return the completed diary to site on a monthly basis.
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
2 Weeks to 12 Months
Healthy volunteers
No
Inclusion criteria
- Parent/Guardian able to provide written informed consent - Within 6 weeks of discharge from hospital for bronchiolitis - Child aged 2 weeks to 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 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. - Currently enrolled to another RCT. (Unless prior approval is given by PI) - Sibling of a BLIPA participant (of the same household or family)
Outcome results
None listed