Clinical trial NCT06862206: This is a Non-interventional, Study to Assess Demographic Characteristics and Patient Reported Outcomes in China Patients With SEA Treated With Benralizumab
Official title: A Multicentre, Single Arm, Non-interventional, Prospective Study to Assess Demographic Characteristics and Patient Reported Outcomes in Patients With Severe Eosinophilic Asthma Treated With Benralizumab in China
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-03-06
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: severe eosinophilic asthma

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.


Eligibility criteria: 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 exclusion criteria are fulfilled:

* 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.

Primary outcomes:
measure: asthma control questionnaire
timeFrame: Week 8
Secondary outcomes:
measure: asthma control questionnaire
timeFrame: week 1, 2, 4, 8, 16, 24, 40 and 56.
measure: changes in lung function
timeFrame: week 8, 16 and 56
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Jingmei Group General Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Haidian Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Chongqing
country: China
facility: Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: First Hospital Affiliated to Fujian Medical University
state: Fujian
city: Fuzhou
country: China
facility: Union Hospital Affiliated to Fujian Medical University
state: Fujian
city: Quanzhou
country: China
facility: Quanzhou First Hospital
state: Fujian
city: Zhangzhou
country: China
facility: Zhangzhou City Hospital
state: Fujian
city: Foshan
country: China
facility: Foshan First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: First Affiliated Hospital, Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: First Affiliated Hospital of Jinan University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Zhongshan
country: China
facility: Sun Yat-sen University Affiliated Fifth Hospital
state: Guangdong
city: Nanning
country: China
facility: First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Shijiazhuang
country: China
facility: Hebei Medical University Second Hospital
state: Hebei
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Hebei
city: Zhengzhou
country: China
facility: Zhengzhou People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Wuhan Central Hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Second Hospital, Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Jiangning Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Dalian
country: China
facility: First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: Second Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: First Affiliated Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: Second Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Shandong First Medical University Affiliated Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: First Affiliated Hospital of Shandong First Medical University
state: Shandong
city: Jining
country: China
facility: Jining Medical University Affiliated Hospital
state: Shandong
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao University Affiliated Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
city: Weifang
country: China
facility: Weifang Second People's Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Tongji Hospital Affiliated to Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Oriental Hospital
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Xian
country: China
facility: Xijing Hospital, Air Force Medical University
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Third People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Fifth People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Tianjin
country: China
facility: General Hospital of Tianjin Medical University
state: Tianjin
city: Kunming
country: China
facility: Yunnan Provincial First People's Hospital
state: Yunnan
city: Kunming
country: China
facility: Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: First Hospital Affiliated to Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
state: Zhejiang
city: Huzhou
country: China
facility: Huzhou Central Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo University Affiliated Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Wenzhou
country: China
facility: Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Zhengzhou
Study officials:
affiliation: China-Japan Friendship Hospital
name: chen wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: