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

May 18, 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

Study Locations

  • China
      • 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
Other: benralizumab
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.
  • 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.
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

AstraZeneca

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)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

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)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 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.

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