We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Other acute lower respiratory infectionsSymptoms and signs involving the circulatory and respiratory systems
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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 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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
1. Any previous hospital attendance for bronchiolitis 2. More than one episode of healthcare professional-diagnosed wheeze prior to index bronchiolitis episode 3. Premature gestational age less than 37 weeks 4. 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. 5. History of clinically significant neonatal disease (e.g. neonatal pneumonia,congenital lung abnormality,neonatal chronic lung disease) 6. Genetic conditions that affect the immune system (e.g. Down’s syndrome/Trisomy 21) 7. Current regular oral montelukast or inhaled corticosteroid therapy or inhaled salbutamol therapy 8. Current regular treatment with immunomodulatory drugs (e.g oral steroids) 9. Known allergy or previous intolerance to study medication. 10. Enrolment in another clinical trial of a medicinal product is excluded. Non-CTIMP study participation is allowed. 11. Sibling of a BLIPA participant (of the same household or family)
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Queen Mary University of London and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 52498
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
