This is a Non-interventional, Study to Assess Demographic Characteristics and Patient Reported Outcomes in China Patients With SEA Treated With Benralizumab (SPEED)
July 21, 2026 updated by: AstraZeneca
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: 1-877-240-9479
- Email: information.center@astrazeneca.com
Study Locations
-
-
-
Anhui, China
- Recruiting
- Research Site
-
Anning, China
- Recruiting
- Research Site
-
Beijing, China
- Recruiting
- Research Site
-
Binzhou, China
- Recruiting
- Research Site
-
Changzhou, China
- Recruiting
- Research Site
-
Fenyang, China
- Recruiting
- Research Site
-
Guangdong, China
- Recruiting
- Research Site
-
Guangzhou, China
- Recruiting
- Research Site
-
Hangzhou, China
- Recruiting
- Research Site
-
Huzhou, China
- Recruiting
- Research Site
-
Jiaxing, China
- Recruiting
- Research Site
-
Jinan, China
- Recruiting
- Research Site
-
Jinhua, China
- Recruiting
- Research Site
-
Jining, China
- Recruiting
- Research Site
-
Jiyuan, China
- Recruiting
- Research Site
-
Kunshan, China
- Recruiting
- Research Site
-
Linyi, China
- Recruiting
- Research Site
-
Mianyang, China
- Recruiting
- Research Site
-
Nanbu, China
- Recruiting
- Research Site
-
Nanchang, China
- Recruiting
- Research Site
-
Nanjing, China
- Recruiting
- Research Site
-
Ningbo, China
- Recruiting
- Research Site
-
Shanghai, China
- Recruiting
- Research Site
-
Shanxi, China
- Recruiting
- Research Site
-
Shenzhen, China
- Recruiting
- Research Site
-
Shijiazhuang, China
- Recruiting
- Research Site
-
Suining, China
- Recruiting
- Research Site
-
Taiyuan, China
- Recruiting
- Research Site
-
Weifang, China
- Recruiting
- Research Site
-
Wuhan, China
- Recruiting
- Research Site
-
Wuxi, China
- Recruiting
- Research Site
-
Xi'an, China
- Recruiting
- Research Site
-
Xiamen, China
- Recruiting
- Research Site
-
Zhangjiagang, China
- Recruiting
- Research Site
-
Zhengzhou, China
- Recruiting
- Research Site
-
Zhenjiang, China
- Recruiting
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
severe eosinophilic asthma
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
benralizumab group
non-interventional
|
non-interventional
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
asthma control questionnaire
Time Frame: Week 8
|
To describe the change in asthma control questionnaire at early time point after initiation of benralizumab
|
Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
asthma control questionnaire
Time Frame: week 1, 2, 4, 8, 16, 24, 40 and 56.
|
|
week 1, 2, 4, 8, 16, 24, 40 and 56.
|
|
changes in lung function
Time Frame: week 8, 16 and 56
|
Changes from baseline in pre-BD FEV1 at week 8, 16 and 56 after initiation of benralizumab.
|
week 8, 16 and 56
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: chen wang, PhD, China-Japan Friendship Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 11, 2025
Primary Completion (Estimated)
January 30, 2028
Study Completion (Estimated)
January 30, 2028
Study Registration Dates
First Submitted
March 3, 2025
First Submitted That Met QC Criteria
March 3, 2025
First Posted (Actual)
March 6, 2025
Study Record Updates
Last Update Posted (Actual)
July 22, 2026
Last Update Submitted That Met QC Criteria
July 21, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D3250R00131
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.