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

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AstraZeneca

Status

Enrolling

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Other: benralizumab

Study type

Observational

Funder types

Industry

Identifiers

NCT06862206
D3250R00131

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

1,000 participants in 1 patient group

benralizumab group
Description:
non-interventional
Treatment:
Other: benralizumab

Trial contacts and locations

16

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Central trial contact

AstraZeneca Clinical Study Information Center

Data sourced from clinicaltrials.gov

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