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

Not yet 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

Recruitment & Eligibility

Status
NOT_YET_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
NameTimeMethod
asthma control questionnaireWeek 8

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

Secondary Outcome Measures
NameTimeMethod
asthma control questionnaireweek 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 functionweek 8, 16 and 56

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

Trial Locations

Locations (100)

Beijing Haidian Hospital

🇨🇳

Beijing, Beijing, China

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

Peking University Third Hospital

🇨🇳

Beijing, Beijing, China

Beijing Hospital

🇨🇳

Beijing, Beijing, China

Beijing Tongren Hospital

🇨🇳

Beijing, Beijing, China

Peking Union Medical College Hospital

🇨🇳

Beijing, Beijing, China

Second Affiliated Hospital of Chongqing Medical University

🇨🇳

Chongqing, Chongqing, China

The First Affiliated Hospital of Chongqing Medical University

🇨🇳

Chongqing, Chongqing, China

First Hospital Affiliated to Fujian Medical University

🇨🇳

Fuzhou, Fujian, China

Union Hospital Affiliated to Fujian Medical University

🇨🇳

Fuzhou, Fujian, China

Quanzhou First Hospital

🇨🇳

Quanzhou, Fujian, China

Zhangzhou City Hospital

🇨🇳

Zhangzhou, Fujian, China

Foshan First People's Hospital

🇨🇳

Foshan, Guangdong, China

First Affiliated Hospital of Sun Yat-sen University

🇨🇳

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

🇨🇳

Guangzhou, Guangdong, China

First Affiliated Hospital, Guangzhou Medical University

🇨🇳

Guangzhou, Guangdong, China

Guangdong Provincial Hospital of Chinese Medicine

🇨🇳

Guangzhou, Guangdong, China

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

🇨🇳

Guangzhou, Guangdong, China

Guangzhou First People's Hospital

🇨🇳

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University

🇨🇳

Guangzhou, Guangdong, China

First Affiliated Hospital of Jinan University

🇨🇳

Guangzhou, Guangdong, China

Shenzhen People's Hospital

🇨🇳

Shenzhen, Guangdong, China

Shenzhen Second People's Hospital

🇨🇳

Shenzhen, Guangdong, China

Peking University Shenzhen Hospital

🇨🇳

Shenzhen, Guangdong, China

Sun Yat-sen University Affiliated Fifth Hospital

🇨🇳

Zhongshan, Guangdong, China

First Affiliated Hospital of Guangxi Medical University

🇨🇳

Nanning, Guangxi, China

Hebei Medical University Second Hospital

🇨🇳

Shijiazhuang, Hebei, China

Tianjin First Central Hospital

🇨🇳

Tianjin, Hebei, China

Zhengzhou People's Hospital

🇨🇳

Zhengzhou, Henan, China

Zhengzhou Central Hospital

🇨🇳

Zhengzhou, Henan, China

First Affiliated Hospital of Zhengzhou University

🇨🇳

Zhengzhou, Henan, China

Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

🇨🇳

Wuhan, Hubei, China

Nanjing Drum Tower Hospital

🇨🇳

Nanjing, Jiangsu, China

Jiangsu Provincial People's Hospital

🇨🇳

Nanjing, Jiangsu, China

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

🇨🇳

Wuhan, Hubei, China

Renmin Hospital of Wuhan University

🇨🇳

Wuhan, Hubei, China

Wuhan Central Hospital

🇨🇳

Wuhan, Hubei, China

Jiangsu Province Hospital of Traditional Chinese Medicine

🇨🇳

Nanjing, Jiangsu, China

Xiangya Hospital of Central South University

🇨🇳

Changsha, Hunan, China

Xiangya Second Hospital, Central South University

🇨🇳

Changsha, Hunan, China

First Affiliated Hospital of Dalian Medical University

🇨🇳

Dalian, Liaoning, China

Second Hospital of Xi'an Jiaotong University

🇨🇳

Xi'an, Shaanxi, China

First Affiliated Hospital of Xi'an Jiaotong University

🇨🇳

Xi'an, Shaanxi, China

Jining Medical University Affiliated Hospital

🇨🇳

Jining, Shandong, China

Linyi People's Hospital

🇨🇳

Linyi, Shandong, China

Qingdao University Affiliated Hospital

🇨🇳

Qingdao, Shandong, China

Ruijin Hospital, Shanghai Jiao Tong University

🇨🇳

Shanghai, Shanghai, China

Shanghai Oriental Hospital

🇨🇳

Shanghai, Shanghai, China

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

🇨🇳

Shanghai, Shanghai, China

Shanghai Sixth People's Hospital

🇨🇳

Shanghai, Shanghai, China

Shanghai Changhai Hospital

🇨🇳

Shanghai, Shanghai, China

Nanjing First Hospital

🇨🇳

Nanjing, Jiangsu, China

Nanjing Jiangning Hospital

🇨🇳

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Soochow University

🇨🇳

Suzhou, Jiangsu, China

Wuxi People's Hospital

🇨🇳

Wuxi, Jiangsu, China

Jiangxi Provincial People's Hospital

🇨🇳

Nanchang, Jiangxi, China

Second Affiliated Hospital of Dalian Medical University

🇨🇳

Dalian, Liaoning, China

The First Affiliated Hospital of Soochow University

🇨🇳

Suzhou, Jiangsu, China

First Affiliated Hospital of Nanchang University

🇨🇳

Nanchang, Jiangxi, China

First Affiliated Hospital of China Medical University

🇨🇳

Shenyang, Liaoning, China

Shengjing Hospital of China Medical University

🇨🇳

Shenyang, Liaoning, China

Shandong First Medical University Affiliated Shandong Provincial Hospital

🇨🇳

Jinan, Shandong, China

Qingdao Municipal Hospital

🇨🇳

Qingdao, Shandong, China

Weifang People's Hospital

🇨🇳

Weifang, Shandong, China

Qilu Hospital of Shandong University

🇨🇳

Jinan, Shandong, China

First Affiliated Hospital of Shandong First Medical University

🇨🇳

Jinan, Shandong, China

Weifang Second People's Hospital

🇨🇳

Weifang, Shandong, China

Zhongshan Hospital, Fudan University

🇨🇳

Shanghai, Shanghai, China

Yantai Yuhuangding Hospital

🇨🇳

Yantai, Shandong, China

Shanghai Changzheng Hospital

🇨🇳

Shanghai, Shanghai, China

Shanghai General Hospital

🇨🇳

Shanghai, Shanghai, China

Huadong Hospital Affiliated to Fudan University

🇨🇳

Shanghai, Shanghai, China

Tongji Hospital Affiliated to Tongji University

🇨🇳

Shanghai, Shanghai, China

Shanghai Pulmonary Hospital

🇨🇳

Shanghai, Shanghai, China

First Hospital of Shanxi Medical University

🇨🇳

Taiyuan, Shanxi, China

Shanxi Bethune Hospital

🇨🇳

Taiyuan, Shanxi, China

Xijing Hospital, Air Force Medical University

🇨🇳

Xian, Shanxi, China

Chengdu Third People's Hospital

🇨🇳

Chengdu, Sichuan, China

Chengdu Fifth People's Hospital

🇨🇳

Chengdu, Sichuan, China

West China Hospital, Sichuan University

🇨🇳

Chengdu, Sichuan, China

Sichuan Provincial People's Hospital

🇨🇳

Chengdu, Sichuan, China

Tianjin Chest Hospital

🇨🇳

Tianjin, Tianjin, China

General Hospital of Tianjin Medical University

🇨🇳

Tianjin, Tianjin, China

Yunnan Provincial First People's Hospital

🇨🇳

Kunming, Yunnan, China

Second Affiliated Hospital of Kunming Medical University

🇨🇳

Kunming, Yunnan, China

First Hospital Affiliated to Zhejiang University School of Medicine

🇨🇳

Hangzhou, Zhejiang, China

Second Affiliated Hospital, Zhejiang University

🇨🇳

Hangzhou, Zhejiang, China

Hangzhou First People's Hospital

🇨🇳

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

🇨🇳

Hangzhou, Zhejiang, China

Huzhou Central Hospital

🇨🇳

Huzhou, Zhejiang, China

Ningbo University Affiliated Hospital

🇨🇳

Ningbo, Zhejiang, China

First Affiliated Hospital of Wenzhou Medical University

🇨🇳

Wenzhou, Zhejiang, China

Second Affiliated Hospital of Wenzhou Medical University

🇨🇳

Wenzhou, Zhejiang, China

Henan Provincial People's Hospital

🇨🇳

Zhengzhou, Zhengzhou, China

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