This is a Non-interventional, Study to Assess Demographic Characteristics and Patient Reported Outcomes in China Patients With SEA Treated With Benralizumab
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: benralizumab.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Other benralizumab
non-interventional
Primary outcome measures
- asthma control questionnaire [Time frame: Week 8]
Secondary outcome measures (2)
- asthma control questionnaire [Time frame: week 1, 2, 4, 8, 16, 24, 40 and 56.]
- changes in lung function [Time frame: week 8, 16 and 56]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 36 centers
- Research Site — Anhui
- Research Site — Anning
- Research Site — Beijing
- Research Site — Binzhou
- Research Site — Changzhou
- Research Site — Fenyang
- Research Site — Guangdong
- Research Site — Guangzhou
- … and 28 more centers
Identifiers
NCT: NCT06862206 · D3250R00131