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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
19/03/2021
Date data sharing statement initially provided
15/10/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Australian Benralizumab Registry
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Scientific title
The Thoracic Society of Australia and New Zealand -Australasian Severe Asthma Benralizumab Registry
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Secondary ID [1]
299449
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ESR-18-13872
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Universal Trial Number (UTN)
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Trial acronym
ABR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Severe Asthma
314649
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Condition category
Condition code
Respiratory
312989
312989
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0
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Asthma
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
2
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Target follow-up type
Years
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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.
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Intervention code [1]
315694
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Number of participants with well controlled Severe Asthma (score of 0-0.75) as measured by the Asthma Control Questionnaire-5 (ACQ-5).
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Assessment method [1]
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Timepoint [1]
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6 months post commencement of Benralizumab
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Secondary outcome [1]
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Quality of life assessed using the Juniper's Asthma Quality of Life Questionnaire-Standardised (AQLQ(S))
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Assessment method [1]
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Timepoint [1]
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6,12, 18 and 24 months after Benralizumab commencement
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Secondary outcome [2]
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Change from baseline ACQ-5 up to 24 weeks
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Assessment method [2]
375351
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Timepoint [2]
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6,12, 18 and 24 months after Benralizumab commencement
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Secondary outcome [3]
375352
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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
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Assessment method [3]
375352
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Timepoint [3]
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Medication history at baseline, and at each time point (6,12, 18 and 24 months)
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Secondary outcome [4]
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Number of exacerbations from data linkage to medical records and participant diary,
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Assessment method [4]
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Timepoint [4]
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6,12, 18 and 24 months after Benralizumab commencement
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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;
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
28/10/2019
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Actual
30/09/2019
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Date of last participant enrolment
Anticipated
30/05/2022
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Actual
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Date of last data collection
Anticipated
29/11/2024
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Actual
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Sample size
Target
200
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Accrual to date
110
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Recruitment hospital [1]
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John Hunter Hospital - New Lambton
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Recruitment hospital [2]
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The Alfred - Melbourne
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Recruitment hospital [3]
14899
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [4]
14900
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [5]
14901
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Concord Repatriation Hospital - Concord
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Recruitment hospital [6]
14902
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [7]
14903
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Flinders Private Hospital - Bedford Park
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Recruitment hospital [8]
14905
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Frankston Hospital - Frankston
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Recruitment hospital [9]
14906
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Liverpool Hospital - Liverpool
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Recruitment hospital [10]
14907
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The Prince Charles Hospital - Chermside
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Recruitment hospital [11]
14908
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [12]
14909
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The Royal Adelaide Hospital - Adelaide
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Recruitment hospital [13]
14910
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [14]
14911
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [15]
14912
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St George Hospital - Kogarah
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Recruitment hospital [16]
14913
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St Vincent's Hospital (Darlinghurst) - Darlinghurst
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Recruitment hospital [17]
14915
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
28166
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2305 - New Lambton
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Recruitment postcode(s) [2]
28167
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3004 - Melbourne
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Recruitment postcode(s) [3]
28168
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3084 - Heidelberg
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Recruitment postcode(s) [4]
28169
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2560 - Campbelltown
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Recruitment postcode(s) [5]
28170
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2139 - Concord
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Recruitment postcode(s) [6]
28171
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6150 - Murdoch
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Recruitment postcode(s) [7]
28172
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5042 - Bedford Park
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Recruitment postcode(s) [8]
28174
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3199 - Frankston
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Recruitment postcode(s) [9]
28175
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2170 - Liverpool
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Recruitment postcode(s) [10]
28176
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4032 - Chermside
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Recruitment postcode(s) [11]
28177
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4102 - Woolloongabba
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Recruitment postcode(s) [12]
28178
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5000 - Adelaide
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Recruitment postcode(s) [13]
28179
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2050 - Camperdown
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Recruitment postcode(s) [14]
28180
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6009 - Nedlands
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Recruitment postcode(s) [15]
28181
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2217 - Kogarah
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Recruitment postcode(s) [16]
28182
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2010 - Darlinghurst
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Recruitment postcode(s) [17]
28184
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2145 - Westmead
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Recruitment outside Australia
Country [1]
21895
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New Zealand
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State/province [1]
21895
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Funding & Sponsors
Funding source category [1]
303952
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Commercial sector/Industry
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Name [1]
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AstraZeneca Pty Ltd
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Address [1]
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66 Talavera Road, North Ryde, 2113, NSW Australia
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Country [1]
303952
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
The Thoracic Society of Australia and New Zealand
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Address
Suite 405/5 Hunter Street Sydney, 2000, NSW, Australia.
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Country
Australia
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Secondary sponsor category [1]
304238
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None
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Name [1]
304238
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Address [1]
304238
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Country [1]
304238
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304452
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Hunter New England Human Research Ethics Committee
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Ethics committee address [1]
304452
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The Lodge, Rankin Park Campus
Locked Bag 1 HRMC NSW 2310
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Ethics committee country [1]
304452
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Australia
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Date submitted for ethics approval [1]
304452
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30/04/2019
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Approval date [1]
304452
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08/07/2019
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Ethics approval number [1]
304452
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2019/ETH08669
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Peter Gibson
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Address
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John Hunter Hospital, Lookout Rd, New Lambton Heights NSW 2305
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Country
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Australia
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Phone
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+61 2 40420143
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Laura Mitchell
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Address
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The Thoracic Society of Australia and New Zealand (TSANZ)
Suite 405/5 Hunter Street, Sydney, 2000, NSW, Australia
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Country
96995
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Australia
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Phone
96995
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+61 2 9222 6207
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Fax
96995
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Email
96995
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[email protected]
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Contact person for scientific queries
Name
96996
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Prof Peter Gibson
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Address
96996
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John Hunter Hospital, Lookout Rd, New Lambton Heights NSW 2305
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Country
96996
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Australia
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Phone
96996
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+61 2 40420143
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Fax
96996
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Email
96996
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
individual participant data (IPD) sharing was not included in the approved ethics approval.
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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.
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