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.
The BLIPA study aims to investigate the following research questions: 1. In children hospitalised with bronchiolitis, does Oral Broncho-Vaxom reduce incidence of parent-reported wheeze during 12 months post IMP initiation after a hospital admission for bronchiolitis. 2. Does oral BV reduces the risk of wheeze after bronchiolitis by modulating T cell and Dendritic cells (DC) maturation and altering the gut and airway microbiota. (mechanistic hypothesis) The BLIPA study will combine the results of two multi-centre, randomised trials with similar but separate protocols: BLIPA-United Kingdom (UK), with recruitment in London, Southampton, Cheshire and Aberdeen and BLIPA-Australia, with recruitment in Brisbane, Gold Coast, Melbourne, Darwin and Sydney. BLIPA-UK is funded in the UK by the NIHR (National Institute for Health and Care Research). BLIPA-Australia is funded in Australia by the International Clinical Trial Collaboration (ICTC). ICTC supports Australian researchers to conduct clinical trial research in collaboration with international researchers. The total study duration is 74 months. The primary clinical objective is to recruit a population of eligible participants, to randomise them to oral Broncho Vaxom (3.5mg) or placebo, to be taken daily for 10 days a month over 12-24 months, follow up for 12-24 months and compare primary and secondary outcomes between trial arms. Parents or guardians of children, clinicians involved in their care and trial staff will be blinded to the treatment arm. Recruitment will be for 18 months and children's outcomes will be assessed for 24 months following initiation of Investigational Medicinal Product (IMP) or placebo. Within six weeks of hospital discharge following admission for bronchiolitis, parents or guardians can consent to their child partaking in the study, baseline data is collected, the child is randomised, and the IMP or placebo is initiated (12 months' supply). From the point of treatment initiation, children are followed up for 12-24 months, the same length as the treatment period. There will be at least one scheduled face to face visit at 12 months to dispense a further year's supply of IMP or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
173
Bacterial lysate medicines are made from bacterial cells that are broken down and are intended to stimulate the immune system.
Royal London Hospital
London, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
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
Time frame: 12 months
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.
Wheeze confirmed via one of the following: 1. Prescription for more than one salbutamol inhaler coded in primary care record between 0-12 months post IMP/placebo initiation. 2. Active wheeze code in primary care records between 0-12 months post IMP/placebo initiation. 3. Asthma diagnosis code in primary care records between 0-12 months post IMP/placebo initiation.
Time frame: 12 months
Occurrence of hospital admissions for wheeze-related illness by 12 months.
Occurrence of hospital admissions for wheeze-related illness by 12 months.
Time frame: 12 months
Occurrence of unscheduled medical attendance for wheeze-related illness by 12 months
Occurrence of unscheduled medical attendance for wheeze-related illness (rate\[episodes per child/month\] and yes/no).
Time frame: 12 months
Presence of wheeze diagnosis by 12 months
Presence of wheeze diagnosis by 12 months
Time frame: 12 months
Time to first wheeze episode by 12 months
Time to first wheeze episode by 12 months
Time frame: 0-12 months
Duration of wheeze by 12 months
Duration of wheeze by 12 months
Time frame: 12 months
Development of eczema by 12 months
Development of eczema by 12 months confirmed by parent report at study follow ups (parent reported outcome)
Time frame: 12 months
Development of Dr-diagnosed food allergy by 12 months
Development of Dr-diagnosed food allergy by 12 months
Time frame: 12 months
Occurrence of all-cause acute respiratory infection by 12 months
Occurrence of all-cause acute respiratory infection by 12 months
Time frame: 12 months
Hospital admissions for respiratory related illness (rate[episodes per child-month] and yes/no) by 12 months
Hospital admissions for respiratory related illness (rate\[episodes per child-month\] and yes/no) by 12 months
Time frame: 12 months
Quality of life confirmed by Warwick Child Health and Morbidity by 12 months
Quality of life confirmed by Warwick Child Health and Morbidity by 12 months
Time frame: 12 months
Number of courses of oral corticosteroids for wheeze by 12 months
Number of courses of oral corticosteroids for wheeze by 12 months
Time frame: 12 months
Incidence of adverse events (AEs) for the treatment group by 12 months
Number of AEs by 12 months
Time frame: 12 months
Incidence of serious adverse events (SAEs) for the treatment group by 12 months
Number of SAEs by 12 months
Time frame: 12 months
Incidence of Suspected unexpected serious adverse reactions (SUSARs) for the treatment group by 12 months
Number of SUSARs by 12 months
Time frame: 12 months
Incidence of adverse events (AEs) for the treatment group between 0-24 months
Number of AEs across 0-24 months
Time frame: 0-24 months
Incidence of serious adverse events (SAEs) for the treatment group between 0-24 months
Number of SAEs across 0-24 months
Time frame: 0-24 months
Incidence of Suspected unexpected serious adverse reactions (SUSARs) for the treatment group between 0-24 months
Number of SUSARs across 0-24 months
Time frame: 0-24 months
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