The Efficacy of Bacterial Lysate in Prevention of Asthma

Phase 2

Recruiting

• Conditions: Respiratory Tract Infections; Wheezing; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12621001556831
• Lead Sponsor: Queensland University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-16
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 894

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 RCT. (Unless prior approval is given by PI)
- Sibling of a BLIPA participant (of the same household or family)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 after starting treatment]