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Trial registered on ANZCTR


Registration number
ACTRN12611001106921
Ethics application status
Approved
Date submitted
20/10/2011
Date registered
24/10/2011
Date last updated
26/06/2019
Date data sharing statement initially provided
26/06/2019
Date results information initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Winter-only treatment with omalizumab to prevent asthma exacerbations in children
Scientific title
A phase 3, multi-centre, double-blind, randomised, placebo-controlled study testing the efficacy of winter only treatment with omalizumab for the reduction of asthma exacerbations in children aged 6 to 15 years.
Secondary ID [1] 273246 0
Nil
Universal Trial Number (UTN)
U1111-1125-3449
Trial acronym
RELAX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 279007 0
Condition category
Condition code
Respiratory 279192 279192 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Omalizumab, based on body weight and serum IgE, by subcutaneous injection each two to four weeks for five months over the Australian winter viral season (April to September).
The following paediatric dosing table applies: A dose of 75mg each four weeks is administered for: IgE level 30-100IU/ml and weight 20-40kg.
A dose of 150mg is administered each four weeks for: IgE level 30-100IU/ml and weight 40-90kg; IgE level 100-200IU/ml and weight 20-40kg; IgE level 200-300IU/ml and weight 20-30kg.
A dose of 225 is administered each four weeks for: IgE level 200-300IU/ml and weight 30-40kg; IgE level 300-400IU/ml and weight 20-30kg; IgE level 400-500IU/ml and weight 20-25kg.
A dose of 300mg is administered each four weeks for: IgE level 30-100IU/ml and weight 90-150kg; IgE level 100-200IU/ml and weight 40-90kg; IgE level 200-300IU/ml and weight 40-60kg; IgE level 300-400IU/ml and weight 30-40kg; IgE level 400-500IU/ml and weight 25-30kg; IgE level 500-600IU/ml and weight 20-30kg; IgE level over 600IU/ml and weight 20-25kg.
A dose of 225mg is administered each two weeks for IgE level 700-1100IU/ml and weight 20-25kg; IgE level 700-900 and weight 25-30kg; IgE level 400-700 and weight 30-40kg; IgE level 300-500 and 40-50kg; IgE level 300-400 and weight 50-60kg; IgE level 200-400 and weight 60-70kg; IgE level 200-300 and weight 70-90kg; IgE level 100-200 and weight 90-125kg.
A dose of 300mg is administered each two weeks for IgE level 1100-1300 and weight 20-25kg; IgE level 900-1200 and weight 25-30kg; IgE level 700-900 and weight 30-40kg; IgE level 500-700 and weight 40-50kg; IgE level 400-600 and weight 50-60kg; IgE level 400-500 and weight 60-70kg; IgE level 300-400 and weight 70-90kg; IgE level 200-300 and weight 90-125kg; IgE level 100-200 and weight 125-150kg.
A dose of 375mg is administered each two weeks for IgE level 1200-1300 and weight 25-30kg; IgE level 900-1100 and weight 30-40kg; IgE level 700-900 and weight 40-50kg; IgE level 600-700 and weight 50-60kg; IgE level 500-600 and weight 60-70kg; IgE level 400-500 and weight 70-90kg; IgE level 200-300 and weight 125-150kg.

Drug is administered to the participant by a study doctor who will also record the dose given to measure adherence.
Intervention code [1] 269582 0
Prevention
Intervention code [2] 269587 0
Treatment: Drugs
Comparator / control treatment
Identical placebo by subcutaneous injection each two to four weeks for five months over the Australian winter viral season (April to September)
Control group
Placebo

Outcomes
Primary outcome [1] 279829 0
Proportion of children with acute asthma exacerbations during treatment period. Exacerbations are defined by the ATS/ERS statement on asthma control and exacerbations, namely: use of steriods (recorded in the concomitant medications) and hospitalisation (recorded in unscheduled events and hospital log).
Timepoint [1] 279829 0
1.4 years (1 year 4 months) after intervention commencement
Secondary outcome [1] 294526 0
Proportion of viral respiratory infections that result in lower airway symptoms during the treatment period. Presence of upper and lower respiratory tract infection symptoms will be recorded in a patient diary. Detection and identification of virus will be determined using PCR on nasal washes (collected at every clinic visit) and on nasal swabs (collected by study staff at unscheduled visits if possible and by parents during periods of lower respiratory tract infections).
Timepoint [1] 294526 0
1.4 years (1 year 4 months) after intervention commencement
Secondary outcome [2] 294527 0
Lung function and airway responsiveness over the follow up period. Lung function will be measured by spirometry. Airway responsiveness will be measured by methacholine challenge testing.
Timepoint [2] 294527 0
1.4 years (1 year 4 months) after intervention commencement

Eligibility
Key inclusion criteria
1. Children of either sex, aged 6 to 15 years, with current asthma;
2. Admission to a hospital emergency department in the previous winter season for acute exacerbation of asthma, as defined by the ATS/ERS statement on asthma control and exacerbation;
3. Atopy;
4. Atopic family history;
5. Participants who, in the opinion of the site investigator, are able to comply with the protocol for its duration;
6. Written informed consent signed and dated by parent/legal guardian according to local regulations.
Minimum age
6 Years
Maximum age
15 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Hypersensitivity to omalizumab 2. Treatment with omalizumab within 30 days prior to screening 3. Prolonged high dose oral steroids 4. Participation in another randomised controlled trial within the 3 months preceding inclusion in this study 5. 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
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?



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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA,VIC
Recruitment postcode(s) [1] 4652 0
4000
Recruitment postcode(s) [2] 4653 0
3000
Recruitment postcode(s) [3] 4654 0
6000

Funding & Sponsors
Funding source category [1] 270073 0
Government body
Name [1] 270073 0
National Health and Medical Research Council
Address [1] 270073 0
GPO Box 1421
Canberra ACT 2601
Country [1] 270073 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 269039 0
None
Name [1] 269039 0
Address [1] 269039 0
Country [1] 269039 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272030 0
QLD Children's Health Services (RCH) Human Research Ethics Committee
Ethics committee address [1] 272030 0
Level 3, RCH Foundation Building
Royal Children's Hospital
Herston road
Herston, QLD, 4029
Ethics committee country [1] 272030 0
Australia
Date submitted for ethics approval [1] 272030 0
Approval date [1] 272030 0
02/08/2011
Ethics approval number [1] 272030 0
HREC/11/QRCH/11
Ethics committee name [2] 289627 0
RCH Human Research Ethics
Ethics committee address [2] 289627 0
The Royal Children's Hospital
50 Flemington road
Parkville, Victoria, 3052
Ethics committee country [2] 289627 0
Australia
Date submitted for ethics approval [2] 289627 0
Approval date [2] 289627 0
13/09/2012
Ethics approval number [2] 289627 0
31231A
Ethics committee name [3] 289628 0
Princess Margaret Hospital for Children Ethics Committee
Ethics committee address [3] 289628 0
Princess Margaret Hospital for Children
Roberts road
Subiaco, Western Australia, 6008
Ethics committee country [3] 289628 0
Australia
Date submitted for ethics approval [3] 289628 0
Approval date [3] 289628 0
19/04/2012
Ethics approval number [3] 289628 0
1957/EP

Summary
Brief summary
Background
Asthma is a huge social and economic burden on our community. Acute exacerbations of asthma are linked with worse lung outcomes for children. In school aged children a risk for acute exacerbations include viral infections, which occur mainly in winter, and allergy.

A drug called omalizumab may help prevent acute exacerbations by damping the allergy response.

Aim
We want to see if omalizumab will decrease the number of children with asthma having an acute exacerbation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33289 0
Prof Peter Sly
Address 33289 0
Queensland Children's Medical Research Institute University of Queensland
Level 7, Center for Children's Health Research
62 Graham Street
South Brisbane QLD 4101
Country 33289 0
Australia
Phone 33289 0
+61 7 3069 7383
Fax 33289 0
Email 33289 0
p.sly@uq.edu.au
Contact person for public queries
Name 16536 0
Prof Peter Sly
Address 16536 0
Queensland Children's Medical Research Institute University of Queensland
Level 7, Center for Children's Health Research
62 Graham Street
South Brisbane QLD 4101
Country 16536 0
Australia
Phone 16536 0
+61 7 3069 7383
Fax 16536 0
+61 7 3069 7159
Email 16536 0
CLEAR@uq.edu.au
Contact person for scientific queries
Name 7464 0
Prof Professor Peter Sly
Address 7464 0
Queensland Children's Medical Research Institute University of Queensland
Level 7, Center for Children's Health Research
62 Graham Street
South Brisbane QLD 4101
Country 7464 0
Australia
Phone 7464 0
+61 7 3069 7383
Fax 7464 0
+61 7 3069 7159
Email 7464 0
p.sly@uq.edu.au

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?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary