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

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

Non Recruiting
All
Phase N/A

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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

Description

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.

Eligibility

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

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

NCT05729711

AstraZeneca

20 August 2025

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