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

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT06862206
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-03
• Study First Posted: 2025-03-06
• Status Verified: 2025-07
• Study Start: 2025-07-11
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-24
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
asthma control questionnaire	Week 8	To describe the change in asthma control questionnaire at early time point after initiation of benralizumab

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (100)

The Second Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Beijing Chaoyang Hospital; 🇨🇳 Beijing, Beijing, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Jingmei Group General Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Haidian Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Hospital; 🇨🇳 Beijing, Beijing, China

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