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Trial registered on ANZCTR


Registration number
ACTRN12614000062628
Ethics application status
Approved
Date submitted
14/01/2014
Date registered
20/01/2014
Date last updated
27/11/2019
Date data sharing statement initially provided
27/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing asthma exacerbations in children aged 6 to 12 years with atopic asthma using a winter only treatment with OM-85
Scientific title
A phase 3, multi-centre, double blind, randomised, placebo-controlled study testing the efficacy of winter only treatment with OM-85 for the reduction of lower respiratory events in atopic children with asthma aged 6 to 12 years
Secondary ID [1] 283899 0
None
Universal Trial Number (UTN)
Trial acronym
OM Child
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 290892 0
Atopy 290929 0
Condition category
Condition code
Respiratory 291245 291245 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug Substance Name: OM-85
Drug Product Name: Broncho-Vaxom

Dose: 3.5mg daily
Duration: 10 days followed by 20 days no treatment for 5 months beginning in March/April
Mode of administration: Oral

Adherence will be measured by return of empty and full drug blister packs.
Intervention code [1] 288577 0
Treatment: Drugs
Comparator / control treatment
Placebo: Hard gelatine capsules with the active principle replaced by mannitol
Control group
Placebo

Outcomes
Primary outcome [1] 291243 0
The mean number of lower respiratory events per patient over the treatment period.

Lower respiratory events are defined as a wheezy lower respiratory infection lasting two or more days requiring additional asthma medication. Events will be recorded via patient daily diary.
Timepoint [1] 291243 0
- Two weeks after the last dose of treatment (5 months after start of treatment), and
- Three months after last dose of treatment
Secondary outcome [1] 306321 0
Mean change in C-ACT score
Timepoint [1] 306321 0
- Two weeks after the last dose of treatment (5 months after start of treatment), and
- Three months after last dose of treatment
Secondary outcome [2] 306322 0
The mean frequency and duration of upper and lower respiratory tract infection (RTI) over the treatment period assessed using a patient daily diary.
Timepoint [2] 306322 0
- Two weeks after the last dose of treatment (5 months after start of treatment), and
- Three months after last dose of treatment
Secondary outcome [3] 306323 0
The cumulative frequency and duration of event free days over the treatment period assessed using patient daily diary. An event free day is defined as a day without respiratory symptoms.
Timepoint [3] 306323 0
- Two weeks after the last dose of treatment (5 months after start of treatment), and
- Three months after last dose of treatment
Secondary outcome [4] 306324 0
The cumulative frequency and duration of upper and lower RTI over the treatment period assessed using patient daily diary.
Timepoint [4] 306324 0
- Two weeks after the last dose of treatment (5 months after start of treatment), and
- Three months after last dose of treatment
Secondary outcome [5] 306325 0
Lung function over the treatment period assessed using the Forced Oscillation Technique.
Timepoint [5] 306325 0
- Two weeks after the last dose of treatment (5 months after start of treatment), and
- Three months after last dose of treatment

Eligibility
Key inclusion criteria
Children of either sex, aged 6 to younger than 12 years, with current asthma;

At least one moderate or severe exacerbation of asthma, as defined by the ATS/ERS statement on asthma control and exacerbation, in the past 12 months;

A C-ACT score of less than or equal to 19;

Positive skin prick test to either mould, house dust mite or cat;

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

Written informed consent signed and dated by parent/legal guardian according to local regulations.
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who has previously received OM-85 in the past 3 months;

If female and currently pregnant, breastfeeding or of child-bearing potential without reliable contraceptive methods;

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

A significant medical disease or condition other than asthma that is likely to interfere with the child’s ability to complete the entire protocol.

Study design
Purpose of the study
Treatment
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 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/03/2014
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
7/05/2014
Date of last data collection
Anticipated
31/12/2017
Actual
31/12/2015
Sample size
Target
90
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
QLD,VIC

Funding & Sponsors
Funding source category [1] 288541 0
Government body
Name [1] 288541 0
Office of Health and Medical Research
Country [1] 288541 0
Australia
Funding source category [2] 288542 0
Commercial sector/Industry
Name [2] 288542 0
Vifor Pharma P/L
Country [2] 288542 0
Switzerland
Primary sponsor type
University
Name
The University of Queensland
Address
Queensland Children's Research Institute
Level 4, Foundation Building
Royal Children's Hospital
Herston road
Herston, QLD, 4029
Country
Australia
Secondary sponsor category [1] 287252 0
None
Name [1] 287252 0
Address [1] 287252 0
Country [1] 287252 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290406 0
Children's Health Services Human Research Ethics Committee
Ethics committee address [1] 290406 0
Level 3, Foundation Building
Department of Paediatrics and Child Health
Royal Children's Hospital
Herston road
Herston QLD 4029
Ethics committee country [1] 290406 0
Australia
Date submitted for ethics approval [1] 290406 0
18/11/2013
Approval date [1] 290406 0
10/12/2013
Ethics approval number [1] 290406 0
EC00175
Ethics committee name [2] 290407 0
Princess Margaret Hospital for Children Ethics Committee
Ethics committee address [2] 290407 0
GPO Box D184
Perth WA 6840
Ethics committee country [2] 290407 0
Australia
Date submitted for ethics approval [2] 290407 0
13/01/2014
Approval date [2] 290407 0
Ethics approval number [2] 290407 0
EC00268

Summary
Brief summary
Asthma imposes a huge social and economic burden on our community, accounting for approximately 1.4% of the total expenditure on health in Australia. Major risk factors for exacerbations include previous exacerbations, young age, poorly controlled asthma, and, in particular, viral respiratory infections. Viral induced exacerbations account for between 80 to 85% of all asthma exacerbations, with the most common viruses including rhinovirus, respiratory syncytial virus, human metapneumovirus and the influenza virus.

The primary aim of this study is to prevent lower respiratory tract infections over the treatment period using a novel bacterial-derived immunostimulant OM85.

OM85 has bacterial lysates of strains frequently encountered in respiratory infections. OM85 BV reduces the susceptibility to suffer from recurrent respiratory infections by priming the immune system. This will help in preventing and reducing the respiratory symptoms to better control asthma in children and reduce severe exacerbations of asthma in children. Lower respiratory events are defined as a wheezy lower respiratory infection lasting three or more days requiring additional asthma medication.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45518 0
Prof Peter Sly
Address 45518 0
Level 7, Centre for Children's Health Research, The University of Queensland, 62 Graham road, South Brisbane 4101
Country 45518 0
Australia
Phone 45518 0
+61 7 3069 7383
Fax 45518 0
+61 7 3069 7159
Email 45518 0
[email protected]
Contact person for public queries
Name 45519 0
Peter Sly
Address 45519 0
Level 7, Centre for Children's Health Research, The University of Queensland, 62 Graham road, South Brisbane 4101
Country 45519 0
Australia
Phone 45519 0
+61730697383
Fax 45519 0
+61 7 3069 7159
Email 45519 0
[email protected]
Contact person for scientific queries
Name 45520 0
Peter Sly
Address 45520 0
Level 7, Centre for Children's Health Research, The University of Queensland, 62 Graham road, South Brisbane 4101
Country 45520 0
Australia
Phone 45520 0
+61 7 3069 7383
Fax 45520 0
+61 7 3069 7159
Email 45520 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.