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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Bronchial Asthma (Only the Patients With Severe or Intractable Bronchial Asthma Which Could Not be Controlled With the Existing Therapy) Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aichi, Japan

About this study

The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire.

Development of related AEs
Contributing factors possibly having an impact on the safety and effectiveness
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Incidence of ADRs

Time frame: 156 weeks

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

TEZSPIRE Subcutaneous Injection 210mg Specific Use-results Study (Long Term) in Patients With Bronchial Asthma.

Important dates

Study start: 2023
Primary completion: 2029
Study completion: 2029
First posted: Feb 15, 2023
Registry last updated: Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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