Bacterial Lysate In Preventing Asthma

Asthma in Children Clinical Trial

— BLIPA  

Official title:

Oral Bacterial Lysate to Prevent Persistent Wheeze in Infants After Severe Bronchiolitis; a Randomised Placebo-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05710081
• Other study ID #: 295882
• Secondary ID: 2021-000628-36
• Status: Recruiting
• Phase: Phase 3
• Start date: November 30, 2021
• Est. completion date: March 1, 2025

Study information

• Verified date: December 2022
• Source: Barts & The London NHS Trust
• Contact: Ann Thomson
• Phone: 07919 659975
• Email: blipa[@]qmul.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn about the effects of using bacterial lysate in bronchiolitis. The main question it aims to answer are: Does the use of bacterial lysate after bronchiolitis reduce the likelihood of preschool wheeze Participants will take either the active medicine or a placebo for 24 months.

Description:

To establish whether there is superiority of oral BV (broncho vaxom) over placebo in the prevention of parent-reported, healthcare professional-confirmed, persistent wheeze between 19 and 24 months post initiation of IMP/placebo, after a hospital admission for severe bronchiolitis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 894
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Weeks to 12 Months

Eligibility

INCLUSION CRITERIA

1. Parent/Guardian able to provide written informed consent

2. Within 6 weeks of discharge from hospital following admission for bronchiolitis

3. Child aged is =2 weeks of age and = 12 months on the date of hospital admission for Bronchiolitis

4. A diagnosis of Bronchiolitis requiring a hospital admission (defined as more than 4 hours in hospital)

5. Contactable for regular follow up by the research team EXCLUSION CRITERIA

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 34 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. Non-CTIMP study participation is allowed.

11. Sibling of a BLIPA participant (of the same household or family)

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Bronchiolitis
• Respiratory Sounds
• Wheezing

Intervention

Biological:
• Bacterial Lysate
Bacterial Lysate

Drug:
• Placebo
Placebo

Locations

Country	Name	City	State
United Kingdom	Barts Health NHS Trust	London

Sponsors (6)

Lead Sponsor	Collaborator
Barts & The London NHS Trust	King's College London, Menzies School of Health Research, University of Aberdeen, University of Edinburgh, University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference in children between treatment with BV granules or placebo in parent-reported clinical outcome measures between 0-24 months.	Time in days to first episode of wheeze from initiation of IMP or placebo Number of unscheduled medical attendances for wheeze Number of hospital admissions for wheeze Number of days admitted to hospital for wheeze Number of unscheduled medical attendances for any lower respiratory symptoms Number of courses of systemic corticosteroids (within the 24 months post initiation of IMP or placebo) Number of courses of oral corticosteroids for wheeze Number of courses of antibiotics This will be a combination outcome of the following factors. Prescription of regular oral montelukast (yes/no)	24 months
Other	Assess compliance with the medications	Combination outcome combining the following. Compliance with medication assessed from monthly questionnaires completed by parents and guardians.; The effect of oral BV on parent-reported, healthcare-professional confirmed wheeze in the stratum of patients that have met compliance as defined as 80% of capsules taken across the whole 24 months.	24 months
Other	Parents and healthcare professionals' self-assessment of blinding	Parent prediction: BV or placebo Healthcare professional prediction: BV or placebo	24 months
Other	Markers of atopy and BV function	Blood serum total and specific IgE and blood eosinophil	24 months
Primary	Occurrence of parent-reported, healthcare professional-confirmed wheeze between 19 and 24 months after initiation of IMP or placebo.	Occurrence of parent-reported, healthcare professional-confirmed wheeze between 19 and 24 months after initiation of IMP or placebo.	24 months
Secondary	Use of medication	Prescription for more than one salbutamol inhaler	24 months
Secondary	Asthma or Wheeze Diagnosis	Active wheeze diagnosis on primary care record Asthma diagnosis on primary care record Parental report of wheeze episode - time in days to first episode of wheeze from initiation of IMP or placebo	24 months
Secondary	Unscheduled Medical attendances	Number of unscheduled medical attendances for wheeze Number of hospital admissions for wheeze Number of days admitted to hospital for wheeze Number of unscheduled medical attendances for any lower respiratory symptoms	24 months
Secondary	Number of courses of oral steroids	Number of courses of systemic corticosteroids (within the 24 months post initiation of IMP or placebo) Number of courses of oral corticosteroids for wheeze	24 months
Secondary	Montelukast use	Prescription of regular oral montelukast (yes/no)	24 months
Secondary	Number of courses of antibiotics	Number of courses of antibiotics	24 months
Secondary	Eczema diagnosis	Eczema (yes/no) Eczema confirmed by U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis.	24 months
Secondary	Safety and Tolerability	Number of AE/SAE/SUSAR events across 0-24 months and 19-24 months	24 months