Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD
Brief summary
The objective of this study is to collect empirical data that elucidates the clinical profile and therapeutic efficacy of benralizumab among the patients aged 12 years and above, with severe eosinophilic asthma. The study will focus on the early treatment response, treatment outcomes and the change in asthma control of benralizumab therapy in a real-world setting in China. This study will also describe the physician-reported reasons for discontinuation and switching of benralizumab therapy.
Interventions
OTHERbenralizumab
non-interventional
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
-Patients are eligible to be included in the study only if all of the following criteria apply: * Patients must to be 12 years old (inclusive) at the time of signing the informed consent. * Patients with severe eosinophilic asthma prescribed with benralizumab at the discretion of the clinician. * Blood EOS≥150/ul in the 3 months prior to or EOS≥300/ul in the 1 year prior to the time of signing the informed consent. * Participating patients and/or their legally authorized representative must provide signed and dated written informed consent form prior to any study specific procedures.
Exclusion criteria
-Patients should not enter the study if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| asthma control questionnaire | Week 8 | To describe the change in asthma control questionnaire at early time point after initiation of benralizumab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| asthma control questionnaire | week 1, 2, 4, 8, 16, 24, 40 and 56. | * Changes from baseline in ACQ-6 at week 1, 2, 4, 16, 24, 40 and 56 after initiation of benralizumab. * The percentage of patients well controlled (defined as ACQ-6 score ≤0.75), partially controlled (defined as ACQ-6 score \>0.75 and \< 1.5) and uncontrolled (defined as ACQ-6 score ≥1.5) at week 1, 2, 4, 8, 16, 24, 40 and 56. * The percentage of patients who had clinically meaningful change of ACQ-6 (defined as at least (≥) 0.5-unit improvement in ACQ-6 score) at the end of treatment at week 1, 2, 4, 8, 16, 24, 40 and 56. |
| changes in lung function | week 8, 16 and 56 | Changes from baseline in pre-BD FEV1 at week 8, 16 and 56 after initiation of benralizumab. |
Countries
China
Contacts
CONTACTAstraZeneca Clinical Study Information Center
PRINCIPAL_INVESTIGATORchen wang, PhD
China-Japan Friendship Hospital
Outcome results
None listed