This is a Non-interventional, Study to Assess Demographic Characteristics and Patient Reported Outcomes in China Patients With SEA Treated With Benralizumab

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients currently participating in any other clinical trial.

Known history of allergy or reaction to any component of the study treatment formulation.

Malignancy of any kind.

Patients with prior or ongoing treatment with benralizumab.

Trial population

severe eosinophilic asthma

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • benralizumab

    Other intervention

    non-interventional

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: benralizumab group1 intervention

Trial outcomes

Primary outcomes

1

asthma control questionnaire

To describe the change in asthma control questionnaire at early time point after initiation of benralizumab

Time frame
Week 8

Secondary outcomes

1

asthma control questionnaire

* 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.

Time frame
week 1, 2, 4, 8, 16, 24, 40 and 56.
2

changes in lung function

Changes from baseline in pre-BD FEV1 at week 8, 16 and 56 after initiation of benralizumab.

Time frame
week 8, 16 and 56

Other outcomes

Sponsors and contacts

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