This is a Non-interventional, Study to Assess Demographic Characteristics and Patient Reported Outcomes in China Patients With SEA Treated With Benralizumab
SPEED
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
1 other identifier
observational
1,000
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2025
Typical duration for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2025
CompletedFirst Posted
Study publicly available on registry
March 6, 2025
CompletedStudy Start
First participant enrolled
July 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 21, 2026
April 1, 2026
2.5 years
March 3, 2025
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
asthma control questionnaire
To describe the change in asthma control questionnaire at early time point after initiation of benralizumab
Week 8
Secondary Outcomes (2)
asthma control questionnaire
week 1, 2, 4, 8, 16, 24, 40 and 56.
changes in lung function
week 8, 16 and 56
Study Arms (1)
benralizumab group
non-interventional
Interventions
Eligibility Criteria
severe eosinophilic asthma
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (20)
Research Site
Anhui, China
Research Site
Beijing, China
Research Site
Binzhou, China
Research Site
Guangzhou, China
Research Site
Hangzhou, China
Research Site
Huzhou, China
Research Site
Jinan, China
Research Site
Jinhua, China
Research Site
Jining, China
Research Site
Linyi, China
Research Site
Mianyang, China
Research Site
Nanchang, China
Research Site
Nanjing, China
Research Site
Ningbo, China
Research Site
Shanghai, China
Research Site
Shanxi, China
Research Site
Suining, China
Research Site
Weifang, China
Research Site
Xi'an, China
Research Site
Zhengzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
chen wang, PhD
China-Japan Friendship Hospital
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2025
First Posted
March 6, 2025
Study Start
July 11, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.