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Trial registered on ANZCTR


Registration number
ACTRN12612000518864
Ethics application status
Approved
Date submitted
4/05/2012
Date registered
15/05/2012
Date last updated
16/04/2019
Date data sharing statement initially provided
16/04/2019
Date results information initially provided
16/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
OM-85 in the prevention of asthma in high-risk children
Scientific title
A phase 3, single-centre, double-blind, randomised, placebo-controlled study testing the primary prevention of persistent asthma in high risk children by protection against acute respiratory infections during early childhood using OM-85.
Secondary ID [1] 280436 0
Nil
Universal Trial Number (UTN)
Trial acronym
OMPAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 286409 0
Condition category
Condition code
Respiratory 286659 286659 0 0
Asthma
Inflammatory and Immune System 286727 286727 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
OM-85 capsule powder (3.5mg) in five blocks of 10 days treatment plus 20 days no treatment, during the first two winter viral seasons (April to September) of a child's life. Capsule powder can be dissolved in fruit juice, water or milk for administration. Parents/guardians will be contacted toward the start of each treatment block as a reminder. Parents/guardians will be given a calendar as a reminder to start treatment blocks and to record doses given or missed. Parents/guardians will return empty and full blister packs at study visits to monitor adherence.
Updated from
OM-85 oral liquid

3.5mg (320 microliters as 10 drops) daily for 30 days then four blocks of 10 days treatment, 20 days no treatment each winter season for the first two winters (April to September) of a child's life
 
Reason: Drug formulation changed from liquid to powder
Updated on 22/07/2013 11:43:48 AM
Intervention code [1] 284795 0
Prevention
Updated from
Prevention  
Reason: not changed. field marked as incomplete
Updated on 4/02/2013 3:33:58 PM
Comparator / control treatment
Placebo comprising of excipients of neutralising agents including starch (gluten free).
Updated from
Placebo

Comprising of excipients from active drug including water, sodiums and neutralising agents
 
Reason: Drug formulation changed from liquid to powder
Updated on 22/07/2013 11:43:48 AM
Control group
Placebo

Outcomes
Primary outcome [1] 287062 0
Frequency of severe lower respiratory tract infections (sLRI) (fever +/- wheeze) over the first two winter viral seasons of the child's life
Timepoint [1] 287062 0
Patient diary review at three years of age
Secondary outcome [1] 297291 0
The time to first severe lower respiratory tract infection (sLRI)
Timepoint [1] 297291 0
Patient diary review at three years of age
Secondary outcome [2] 297292 0
The frequency of sLRI during each winter of the study period
Timepoint [2] 297292 0
Patient diary review at three years of age
Secondary outcome [3] 297293 0
The cumulative frequency of sLRI (fever +/- wheeze) during the first 3 years of life
Timepoint [3] 297293 0
Patient diary review at three years of age
Secondary outcome [4] 297294 0
The proportion of children with a doctor diagnosis of asthma during the first 3 years of life
Timepoint [4] 297294 0
Three years of age
Secondary outcome [5] 297295 0
The proportion of children requiring hospitalization for sLRI during the first 3 years of life
Timepoint [5] 297295 0
Review of hospitalization records up to three years of age
Secondary outcome [6] 297296 0
Incidence of hospitalization/accident and Emergency department (A&E) visits for a sLRI
Timepoint [6] 297296 0
Review of hospitalization records up to three years of age
Secondary outcome [7] 297297 0
Number of days hospitalized for sLRI
Timepoint [7] 297297 0
Review of hospitalization records up to three years of age
Secondary outcome [8] 297298 0
Body mass index at 3 years of age
Timepoint [8] 297298 0
Three years of age
Secondary outcome [9] 297299 0
Lung function measures at 3 years of age
Timepoint [9] 297299 0
Lung function measurements using the forced oscillation technique at three years of age

Eligibility
Key inclusion criteria
1. Children of either sex, aged 3-9 months old whose biological mother, father, or sibling has a history of asthma and/or atopy (defined as SPT reactivity to one or more allergen, food allergy, atopic dermatitis or allergic rhinitis) 2. Participants who, in the opinion of the investigator, are able to comply with the protocol for its duration 3. Written informed consent signed and dated by parent/legal guardian according to local regulations
Updated from
1. Children of either sex, aged 3-9 months old whose biological mother, father, or sibling has a history of asthma and/or atopy (defined as SPT reactivity to one or more allergen, food allergy, atopic dermatitis or allergic rhinitis)

2. Normal vaginal delivery (NVD)

3. Children whose full blood picture, serum biochemistry, and liver function test results are within the age- referenced normal range of the site clinical laboratory or have values outside the age- referenced normal range that are not considered clinically significant by the investigator

4. Participants who, in the opinion of the investigator, are able to comply with the protocol for its duration

5. Written informed consent signed and dated by parent/legal guardian according to local regulations
 
Reason: Normal vaginal delivery was taken out as an inclusion criteria to increase recruitment field. This should not impact results as evidence to suggest difference in microbiota of children born to Cesarean section would affect results of the study.
Normal blood laboratory results were excluded to minimise blood draws, and after review of safety data, there is no reason to warrant safety bloods in this population.

Updated on 22/07/2013 11:43:48 AM
Minimum age
3 Months
Maximum age
9 Months
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Children born less than 36 weeks gestation

2. Children who have been diagnosed with asthma

3. Children who have chronic pulmonary disease or other chronic disease (other than atopic dermatitis, food allergy, or chronic rhinitis) requiring therapy

4. Participation in another randomized controlled trial within the 3 months preceding inclusion in this study

5. Children who has previously received OM-85 or other immunostimulant or immunosuppressive drugs including cyclosporine

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)
Participants will be identified antenatally from family history of asthma/allergies. Participants will be enrolled following birth. Participants will be randomised to a treatment using a code assigned by the treatment supplier.
Updated from
 
Reason: new request
Updated on 4/02/2013 3:33:58 PM
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Updated from
Active, not recruiting  
Reason: study complete
Updated on 16/04/2019 10:45:43 AM
Updated from
Recruiting  
Reason: Recruitment completed for study but follow up continuing for enrolled participants
Updated on 15/06/2016 1:30:35 PM
Updated from
Not yet recruiting  
Reason: recruiting will be begin
Updated on 4/02/2013 3:33:58 PM
Date of first participant enrolment
Anticipated
Actual
Updated from
1/03/2013 
Reason: updated information
Updated on 4/02/2013 3:33:58 PM
Updated from
 
Reason: New information - first patient enrolled
Updated on 22/07/2013 11:43:48 AM
Date of last participant enrolment
Anticipated
Actual
Updated from
 
Reason: Anticipated last participant enrolment date updated
Updated on 15/06/2016 1:30:35 PM
Updated from
 
Reason: Actuallast last participant enrolment date updated
Updated on 15/06/2016 1:30:35 PM
Date of last data collection
Anticipated
Actual
Updated from
 
Reason: requested
Updated on 17/04/2018 12:53:45 PM
Updated from
 
Reason: Actual final visit date.
Updated on 16/04/2019 10:45:43 AM
Sample size
Target
Accrual to date
Final
Updated from
 
Reason: Actual sample size updated
Updated on 15/06/2016 1:30:35 PM
Recruitment in Australia
Recruitment state(s)
QLD
Updated from
<br />  
Reason: Recruitment state updated
Updated on 15/06/2016 1:30:35 PM

Funding & Sponsors
Funding source category [1] 285199 0
University
Name [1] 285199 0
Child Health Research Centre, The University of Queensland
Updated from
Queensland Children's Medical Research Institute, The University of Queensland  
Reason: Queensland Children's Medical Research Institute has closed.
Updated on 16/04/2019 10:45:43 AM
Address [1] 285199 0
Level 7, Centre for Child Health Research
62 Graham Street
South Brisbane Queensland 4101
Updated from
Royal Children's Hospital
Level 4, Foundation Building
Herston Road
Herston, QLD, 4029
 
Reason: Hospital moved from Herston to South Brisbane - new facility
Updated on 16/04/2019 10:45:43 AM
Country [1] 285199 0
Australia
Primary sponsor type
University
Name
Child Health Research Centre, University of Queensland
Updated from
Queensland Children's Medical Research Institute, The University of Queensland  
Reason: Queensland Children's Medical Research Institute has closed.
Updated on 16/04/2019 10:45:43 AM
Address
Level 7, Centre for Child Health Research
62 Graham Street
South Brisbane Queensland 4101
Updated from
Royal Children's Hospital<br />Level 4, Foundation Building<br />Herston Road<br />Herston, QLD, 4029  
Reason: Hospital moved from Herston to South Brisbane - new facility
Updated on 16/04/2019 10:45:43 AM
Country
Australia
Secondary sponsor category [1] 284068 0
None
Name [1] 284068 0
Address [1] 284068 0
Country [1] 284068 0

Ethics approval
Ethics application status
Approved
Updated from
No  
Reason: ethics approval has been obtained
Updated on 4/02/2013 3:33:58 PM
Ethics committee name [1] 287200 0
Queensland Children's Health Services (RCH) HREC
Updated from
 
Reason: ethics approval has been obtained
Updated on 4/02/2013 3:33:58 PM
Ethics committee address [1] 287200 0
Ethics committee country [1] 287200 0
Date submitted for ethics approval [1] 287200 0
18/06/2012
Approval date [1] 287200 0
14/08/2012
Updated from
 
Reason: ethics approval has been obtained
Updated on 4/02/2013 3:33:58 PM
Ethics approval number [1] 287200 0

Summary
Brief summary
Persistent asthma is a major problem yet none of the current therapies do more than control the condition. The long-term solution is to prevent asthma from progressing to the persistent form. The major risk factors are: family history, early allergy and recurrent severe lower respiratory infections (sLRI) in the early life. We will conduct a randomized clinical trial to prevent sLRI using a novel bacterial-derived immunostimulant (OM-85) in infants at high risk of developing asthma. OM-85 works by priming the immune system so that body can respond quickly to infections. This will help reduce damage to the lungs during sLRI's and may prevent asthma from developing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Updated from
 
Reason: new request
Updated on 4/02/2013 3:33:58 PM
Name 34137 0
Prof Peter Sly
Updated from
 
Reason: new request
Updated on 4/02/2013 3:33:58 PM
Address 34137 0
Level 7, Centre for Children's Health Research, The University of Queensland, 62 Graham Street, South Brisbane, QLD 4101
Updated from
Level 7, Centre for Children's Health Research, The University of Queensland, 62 Graham road, South Brisbane, QLD 4101  
Reason: Street, not road.
Updated on 16/04/2019 10:45:43 AM
Updated from
Queensland Children's Medical Research Institute
Level 4, Foundation Building
Royal Children's Hospital
Herston road Herston, QLD, 4029
 
Reason: Updated address
Updated on 15/06/2016 1:30:35 PM
Updated from
 
Reason: new request
Updated on 4/02/2013 3:33:58 PM
Country 34137 0
Australia
Updated from
 
Reason: new request
Updated on 4/02/2013 3:33:58 PM
Phone 34137 0
+61 7 3069 7383
Updated from
+61 7 3636 9690  
Reason: Updated contact number
Updated on 15/06/2016 1:30:35 PM
Updated from
 
Reason: new request
Updated on 4/02/2013 3:33:58 PM
Fax 34137 0
+61 7 3069 7159
Updated from
 
Reason: Updated fax number
Updated on 15/06/2016 1:30:35 PM
Email 34137 0
p.sly@uq.edu.au
Updated from
 
Reason: new request
Updated on 4/02/2013 3:33:58 PM
Contact person for public queries
Updated from
Mrs  
Reason: staffing change
Updated on 17/04/2018 12:53:45 PM
Updated from
Dr  
Reason: Person responsible has changed.
Updated on 29/05/2014 11:08:37 AM
Updated from
 
Reason: new request
Updated on 4/02/2013 3:33:58 PM
Name 17384 0
Dr Peter Sly
Updated from
Naima Islam  
Reason: Dr Naima Islam has left the facility
Updated on 16/04/2019 10:45:43 AM
Updated from
Julie Varghese  
Reason: staffing change
Updated on 17/04/2018 12:53:45 PM
Updated from
Catherine Gangell  
Reason: Person responsible has changed.
Updated on 29/05/2014 11:08:37 AM
Updated from
Dr Catherine Gangell  
Reason: removed title
Updated on 4/02/2013 3:33:58 PM
Address 17384 0
Level 7, Centre for Children's Health Research, The University of Queensland, 62 Graham Street, South Brisbane, QLD 4101
Updated from
Level 7, Centre for Children's Health Research, The University of Queensland, 62 Graham road, South Brisbane, QLD 4101  
Reason: Street not road
Updated on 16/04/2019 10:45:43 AM
Updated from
Queensland Children's Medical Research Institute
Level 4, Foundation Building
Royal Children's Hospital
Herston road
Herston, QLD, 4029
 
Reason: Updated address
Updated on 15/06/2016 1:30:35 PM
Country 17384 0
Australia
Phone 17384 0
+61730697445
Updated from
+61 7 3-69 7444  
Reason: staffing change
Updated on 17/04/2018 12:53:45 PM
Updated from
+61 7 3636 1283  
Reason: Updated contact number
Updated on 15/06/2016 1:30:35 PM
Updated from
+61 7 3636 4074  
Reason: Person responsible has changed.
Updated on 29/05/2014 11:08:37 AM
Fax 17384 0
+61 7 3069 7159
Updated from
+61 7 3636 5578  
Reason: Updated fax number
Updated on 15/06/2016 1:30:35 PM
Email 17384 0
p.sly@uq.edu.au
Updated from
naima.islam@uq.edu.au  
Reason: Dr Naima Islam has left the facility
Updated on 16/04/2019 10:45:43 AM
Updated from
julie.v@uq.edu.au  
Reason: staffing change
Updated on 17/04/2018 12:53:45 PM
Updated from
c.gangell@uq.edu.au  
Reason: Person responsible has changed.
Updated on 29/05/2014 11:08:37 AM
Contact person for scientific queries
Updated from
Mrs  
Reason: staffing change
Updated on 17/04/2018 12:53:45 PM
Updated from
Dr  
Reason: Person responsible has changed.
Updated on 29/05/2014 11:08:37 AM
Updated from
 
Reason: new request
Updated on 4/02/2013 3:33:58 PM
Name 8312 0
Dr Peter Sly
Updated from
Naima Islam  
Reason: Dr Naima Islam has left the facility
Updated on 16/04/2019 10:45:43 AM
Updated from
Julie Varghese  
Reason: staffing change
Updated on 17/04/2018 12:53:45 PM
Updated from
Catherine Gangell  
Reason: Person responsible has changed.
Updated on 29/05/2014 11:08:37 AM
Updated from
Dr Catherine Gangell  
Reason: removed title
Updated on 4/02/2013 3:33:58 PM
Address 8312 0
Level 7, Centre for Children's Health Research, The University of Queensland, 62 Graham Street, South Brisbane, QLD 4101
Updated from
Level 7, Centre for Children's Health Research, The University of Queensland, 62 Graham road, South Brisbane, QLD 4101  
Reason: Street not road
Updated on 16/04/2019 10:45:43 AM
Updated from
Queensland Children's Medical Research Institute
Level 4, Foundation Building
Royal Children's Hospital
Herston road
Herston, QLD, 4029
 
Reason: Updated address
Updated on 15/06/2016 1:30:35 PM
Country 8312 0
Australia
Phone 8312 0
+61730697445
Updated from
+61 7 3069 7444  
Reason: staffing change
Updated on 17/04/2018 12:53:45 PM
Updated from
+61 7 3636 1283  
Reason: Updated contact number
Updated on 15/06/2016 1:30:35 PM
Updated from
+61 7 3636 4074  
Reason: Person responsible has changed.
Updated on 29/05/2014 11:08:37 AM
Fax 8312 0
+61 7 3069 7159
Updated from
+61 7 3636 5578  
Reason: Updated fax number
Updated on 15/06/2016 1:30:35 PM
Email 8312 0
p.sly@uq.edu.au
Updated from
naima.islam@uq.edu.au  
Reason: Dr Naima Islam has left the facility
Updated on 16/04/2019 10:45:43 AM
Updated from
julie.v@uq.edu.au  
Reason: staffing change
Updated on 17/04/2018 12:53:45 PM
Updated from
c.gangell@uq.edu.au  
Reason: Person responsible has changed.
Updated on 29/05/2014 11:08:37 AM

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 1885 0
Report
Citation/DOI/link/details [1] 1885 0
https://child-health-research.centre.uq.edu.au/research/research-groups/childrens-health-and-environment-program
Results – basic reporting
Results – plain English summary