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

AstraZeneca

Status: Active, not recruiting

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05729711

D5180C00034

Details and patient eligibility

About

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

Full 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.

Enrollment: 416 patients

Sex: All

Volunteers: No Healthy Volunteers

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