Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05064631




Registration number
NCT05064631
Ethics application status
Date submitted
20/08/2021
Date registered
1/10/2021
Date last updated
3/08/2023

Titles & IDs
Public title
Bacterial Lysate In Preventing Asthma
Scientific title
Oral Bacterial Lysate to Prevent Persistent Wheeze in Infants After Severe Bronchiolitis; a Randomised Placebo-controlled Trial
Secondary ID [1] 0 0
2021-000628-36
Secondary ID [2] 0 0
295882
Universal Trial Number (UTN)
Trial acronym
BLIPA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Digital brief behavioural therapy for insomnia - Participants randomised to the digital brief behavioural therapy for insomnia (SleepFix app) will be provided an unique access code to download the app. The intervention uses sleep retraining therapy to reduce excess time spent in bed and retrain sleep by matching time in bed (minimum of five and a half hours) to total sleep time. All participants in the intervention arm will also be provided a sleep-tracking wearable device (Fitbit) which will synchronised bed times (going to bed and rising) and are synchronised with the SleepFix app. Participants wil complete a daily sleep diary, rate sleep quality and mood. The intervention is provided for 6 weeks.
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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
Minimum age
3 Months
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 Randomised Clinical Trial. (Unless prior approval is given by Principal Investigator)
* Sibling of a BLIPA participant (of the same household or family)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2025
Actual
Sample size
Target
894
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
Queen Mary University of London
Address
Country

Ethics approval
Ethics application status

Summary
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 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 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.
Trial website
https://clinicaltrials.gov/study/NCT05064631
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Jonathan Grigg, Prof. Dr
Address 0 0
Queen Mary University of London
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jonathan Grigg, Prof. Dr
Address 0 0
Country 0 0
Phone 0 0
00447789397850
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05064631