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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.
Intervention code [1] 284795 0
Prevention
Comparator / control treatment
Placebo comprising of excipients of neutralising agents including starch (gluten free).
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
Minimum age
3 Months
Maximum age
9 Months
Sex
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.
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
Date of first participant enrolment
Anticipated
1/02/2013
Actual
10/04/2013
Date of last participant enrolment
Anticipated
31/05/2016
Actual
10/05/2016
Date of last data collection
Anticipated
31/12/2018
Actual
11/10/2018
Sample size
Target
60
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 285199 0
University
Name [1] 285199 0
Child Health Research Centre, The University of Queensland
Country [1] 285199 0
Australia
Primary sponsor type
University
Name
Child Health Research Centre, University of Queensland
Address
Level 7, Centre for Child Health Research
62 Graham Street
South Brisbane Queensland 4101
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
Ethics committee name [1] 287200 0
Queensland Children's Health Services (RCH) HREC
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
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
Name 34137 0
Prof Peter Sly
Address 34137 0
Level 7, Centre for Children's Health Research, The University of Queensland, 62 Graham Street, South Brisbane, QLD 4101
Country 34137 0
Australia
Phone 34137 0
+61 7 3069 7383
Fax 34137 0
+61 7 3069 7159
Email 34137 0
[email protected]
Contact person for public queries
Name 17384 0
Peter Sly
Address 17384 0
Level 7, Centre for Children's Health Research, The University of Queensland, 62 Graham Street, South Brisbane, QLD 4101
Country 17384 0
Australia
Phone 17384 0
+61730697445
Fax 17384 0
+61 7 3069 7159
Email 17384 0
[email protected]
Contact person for scientific queries
Name 8312 0
Peter Sly
Address 8312 0
Level 7, Centre for Children's Health Research, The University of Queensland, 62 Graham Street, South Brisbane, QLD 4101
Country 8312 0
Australia
Phone 8312 0
+61730697445
Fax 8312 0
+61 7 3069 7159
Email 8312 0
[email protected]

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?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePrimary prevention of severe lower respiratory illnesses in at-risk infants using the immunomodulator OM-85.2019https://dx.doi.org/10.1016/j.jaci.2019.05.032
N.B. These documents automatically identified may not have been verified by the study sponsor.