TEZSPIRE (Tezepelumab) Asthma Japan Post-Marketing Study (PMS)

N/AActive Not RecruitingNCT05729711

AstraZeneca416 enrolled

Overview

The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire. 1. Development of related AEs 2. Contributing factors possibly having an impact on the safety and effectiveness 3. Development of unexpected related AEs This investigation will be conducted to support the application for re-examination specified in Article 14-4 of the Act on Securing Quality, Effectiveness and Safety of Products Including Pharmaceuticals and Medical Devices.

Study Type

OBSERVATIONAL

Enrollment

416

Conditions

Bronchial Asthma (Only the Patients With Severe or Intractable Bronchial Asthma Which Could Not be Controlled With the Existing Therapy)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * The evaluable patients are those treated with Tezspire for the first time due to "Bronchial asthma (only the patients with severe or intractable bronchial asthma which could not be controlled with the existing therapy) Exclusion Criteria: None

Locations (34)

Research Site

Aichi, Japan

Outcomes

Primary Outcomes

Incidence of ADRs

the incidence of ADRs related to Tezspire Safety Specifications: Serious hypersensitivity, infection, malignancy, cardiac disorders

Time frame: 156 weeks

Data from ClinicalTrials.gov

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