This is a Non-interventional, Study to Assess Demographic... | NCT06862206

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 11, 2025Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Mar 3, 2025

First Submission Date that Met QC Criteria

Mar 3, 2025

First Posted Date

Mar 6, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2026

Last Update Posted Date

May 19, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
benralizumab group		non-interventional	Other: benralizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
benralizumab	Other	non-interventional	benralizumab group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
asthma control questionnaire	To describe the change in asthma control questionnaire at early time point after initiation of benralizumab	Week 8

Secondary Outcomes

Measure	Description	Time Frame
asthma control questionnaire	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.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

severe eosinophilic asthma

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
AstraZeneca Clinical Study Information Center	Contact	1-877-240-9479		information.center@astrazeneca.com

Overall Officials

Name	Affiliation	Role
chen wang, PhD	China-Japan Friendship Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site	Recruiting	Anhui			China
Research Site

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Not provided

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.

URL

https://vivli.org/

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms