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Trial registered on ANZCTR


Registration number
ACTRN12619001426178
Ethics application status
Approved
Date submitted
30/09/2019
Date registered
15/10/2019
Date last updated
15/10/2019
Date data sharing statement initially provided
15/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian Benralizumab Registry
Scientific title
The Thoracic Society of Australia and New Zealand -Australasian Severe Asthma Benralizumab Registry
Secondary ID [1] 299449 0
ESR-18-13872
Universal Trial Number (UTN)
Trial acronym
ABR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Asthma 314649 0
Condition category
Condition code
Respiratory 312989 312989 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
Severe asthma is defined as ‘Uncontrolled asthma which can result in risk of frequent severe exacerbation (or death) and/or adverse reactions to medications and/or chronic morbidity (including impaired lung function or reduced lung growth in children).’

The Australian Benralizumab Registry will:
· collect and report on data from people with severe refractory eosinophilic asthma who receive benralizumab:
a) as part of the PBS subsidised benralizumab treatment cycle, and the Pharmaceutical Benefits Scheme (PBS) Section 100 Special Authority Program,
or
b) who receive benralizumab for severe refractory eosinophilic asthma outside of the PBS restrictions.

Patients will be followed prospectively for 2 years and data collection will be conducted every 6 months. At patients' visits, data on demographics, anthropometrics, Quality of Life and clinical data will be collected.
Intervention code [1] 315694 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321557 0
Number of participants with well controlled Severe Asthma (score of 0-0.75) as measured by the Asthma Control Questionnaire-5 (ACQ-5).
Timepoint [1] 321557 0
6 months post commencement of Benralizumab
Secondary outcome [1] 375350 0
Quality of life assessed using the Juniper's Asthma Quality of Life Questionnaire-Standardised (AQLQ(S))
Timepoint [1] 375350 0
6,12, 18 and 24 months after Benralizumab commencement
Secondary outcome [2] 375351 0
Change from baseline ACQ-5 up to 24 weeks
Timepoint [2] 375351 0
6,12, 18 and 24 months after Benralizumab commencement
Secondary outcome [3] 375352 0
To assess the change in concomitant medications (including OCS use) over the 56 weeks study period after enrolment in the ABR following initiation of benralizumab in a real-world Australian setting
Timepoint [3] 375352 0
Medication history at baseline, and at each time point (6,12, 18 and 24 months)
Secondary outcome [4] 375894 0
Number of exacerbations from data linkage to medical records and participant diary,
Timepoint [4] 375894 0
6,12, 18 and 24 months after Benralizumab commencement

Eligibility
Key inclusion criteria
1. adults aged 18 years and over;
2. provision of informed consent prior to any study specific procedures;
3. confirmed asthma diagnosis;
4. using maximum therapy [inhaled high dose of corticosteroid and 2nd controller];
5. uncontrolled asthma [currently, or on reduction in maximal therapy], which constitutes each of:
a. poor symptom control: ACQ-5>=2;
b. >=1 severe exacerbation in the past 12 months;
c. airflow obstruction: FEV1<80% predicted;
6. optimised asthma management skills;
7. triggers and relevant co-morbidity have been assessed and managed;
8. eosinophilic asthma as determined from airway sample (induced sputum, BAL >3%) or peripheral blood sample;
9. Blood eosinophil count >=300/µL in the previous 12 months;
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. unable to complete study data collection requirements, unable to participate over 2 year period;
2. people highly dependent on medical care;
3. cognitive impairment preventing completion of data collection forms.

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The sample size for this study was calculated using GPower (Erdfelder et al. 1996). This current study hypothesis is that benralizumab improves asthma control in severe refractory eosinophilic asthma, measured using the ACQ-5. We would aim to detect moderate magnitude of effect of benralizumab therapy on severe refractory eosinophilic asthma control. To obtain a power of 0.80, n = 74 participants will need to be recruited. With an expected drop-out rate of 30% (Lane, 2008), a minimum of approximately 100 patients will be required for this study.

Change in ACQ-5 from baseline to first continuation visit [likely 6 months] will be computed and expressed as mean and sd/ 95% confidence intervals (CI).
Proportion (95% CI) with change in ACQ-5 greater than 0.5.

Recruitment
Recruitment status
Not yet recruiting
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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 14897 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 14898 0
The Alfred - Melbourne
Recruitment hospital [3] 14899 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 14900 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [5] 14901 0
Concord Repatriation Hospital - Concord
Recruitment hospital [6] 14902 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [7] 14903 0
Flinders Private Hospital - Bedford Park
Recruitment hospital [8] 14905 0
Frankston Hospital - Frankston
Recruitment hospital [9] 14906 0
Liverpool Hospital - Liverpool
Recruitment hospital [10] 14907 0
The Prince Charles Hospital - Chermside
Recruitment hospital [11] 14908 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [12] 14909 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [13] 14910 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [14] 14911 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [15] 14912 0
St George Hospital - Kogarah
Recruitment hospital [16] 14913 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [17] 14915 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 28166 0
2305 - New Lambton
Recruitment postcode(s) [2] 28167 0
3004 - Melbourne
Recruitment postcode(s) [3] 28168 0
3084 - Heidelberg
Recruitment postcode(s) [4] 28169 0
2560 - Campbelltown
Recruitment postcode(s) [5] 28170 0
2139 - Concord
Recruitment postcode(s) [6] 28171 0
6150 - Murdoch
Recruitment postcode(s) [7] 28172 0
5042 - Bedford Park
Recruitment postcode(s) [8] 28174 0
3199 - Frankston
Recruitment postcode(s) [9] 28175 0
2170 - Liverpool
Recruitment postcode(s) [10] 28176 0
4032 - Chermside
Recruitment postcode(s) [11] 28177 0
4102 - Woolloongabba
Recruitment postcode(s) [12] 28178 0
5000 - Adelaide
Recruitment postcode(s) [13] 28179 0
2050 - Camperdown
Recruitment postcode(s) [14] 28180 0
6009 - Nedlands
Recruitment postcode(s) [15] 28181 0
2217 - Kogarah
Recruitment postcode(s) [16] 28182 0
2010 - Darlinghurst
Recruitment postcode(s) [17] 28184 0
2145 - Westmead
Recruitment outside Australia
Country [1] 21895 0
New Zealand
State/province [1] 21895 0

Funding & Sponsors
Funding source category [1] 303952 0
Commercial sector/Industry
Name [1] 303952 0
AstraZeneca Pty Ltd
Address [1] 303952 0
66 Talavera Road, North Ryde, 2113, NSW Australia
Country [1] 303952 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Thoracic Society of Australia and New Zealand
Address
Suite 405/5 Hunter Street Sydney, 2000, NSW, Australia.
Country
Australia
Secondary sponsor category [1] 304238 0
None
Name [1] 304238 0
Address [1] 304238 0
Country [1] 304238 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304452 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 304452 0
The Lodge, Rankin Park Campus
Locked Bag 1 HRMC NSW 2310
Ethics committee country [1] 304452 0
Australia
Date submitted for ethics approval [1] 304452 0
30/04/2019
Approval date [1] 304452 0
08/07/2019
Ethics approval number [1] 304452 0
2019/ETH08669

Summary
Brief summary
The Australian Benralizumab Registry (the ABR) wil collect and report on data from people with severe refractory eosinophilic asthma who receive benralizumab:
o as part of the PBS subsidised benralizumab treatment cycle, and the Pharmaceutical Benefits Scheme (PBS) Section 100 Special Authority Program,
or
o who receive benralizumab for severe refractory eosinophilic asthma outside of the PBS restrictions.

The ABR will provide a mechanism for sharing information which will help researchers and clinicians to better understand the use, efficacy, and safety associated with the treatment of severe asthma with benralizumab. All information collected from participating sites will be securely stored in the main data repository. Access to the ABR will be restricted to authorised users. The ABR will report regularly on characteristics and outcomes for this population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96994 0
Prof Peter Gibson
Address 96994 0
John Hunter Hospital, Lookout Rd, New Lambton Heights NSW 2305
Country 96994 0
Australia
Phone 96994 0
+61 2 40420143
Fax 96994 0
Email 96994 0
Peter.Gibson@health.nsw.gov.au
Contact person for public queries
Name 96995 0
Ms Lauren Coulson
Address 96995 0
The Thoracic Society of Australia and New Zealand (TSANZ)
Suite 405/5 Hunter Street, Sydney, 2000, NSW, Australia
Country 96995 0
Australia
Phone 96995 0
+61 2 9222 6207
Fax 96995 0
Email 96995 0
ASAR@thoracic.org.au
Contact person for scientific queries
Name 96996 0
Prof Peter Gibson
Address 96996 0
John Hunter Hospital, Lookout Rd, New Lambton Heights NSW 2305
Country 96996 0
Australia
Phone 96996 0
+61 2 40420143
Fax 96996 0
Email 96996 0
Peter.Gibson@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
individual participant data (IPD) sharing was not included in the approved ethics approval.
What supporting documents are/will be available?
No other documents available
Summary results
No Results