Australian Benralizumab Registry

Not Applicable

Recruiting

• Conditions: Severe Asthma; Respiratory - Asthma

• Registration Number: ACTRN12619001426178
• Lead Sponsor: The Thoracic Society of Australia and New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-15
• Last Update Posted: 29 March 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

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;

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of participants with well controlled Severe Asthma (score of 0-0.75) as measured by the Asthma Control Questionnaire-5 (ACQ-5). [6 months post commencement of Benralizumab]

Secondary Outcome Measures

Name	Time	Method
Quality of life assessed using the Juniper's Asthma Quality of Life Questionnaire-Standardised (AQLQ(S))[6,12, 18 and 24 months after Benralizumab commencement];Change from baseline ACQ-5 up to 24 weeks<br>[6,12, 18 and 24 months after Benralizumab commencement];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[Medication history at baseline, and at each time point (6,12, 18 and 24 months)];Number of exacerbations from data linkage to medical records and participant diary,[6,12, 18 and 24 months after Benralizumab commencement]