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

NCT ID: NCT05729711

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

416 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-04

Study Completion Date

2029-11-16

Brief Summary

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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

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Toshimitsu Tokimoto

Role: STUDY_DIRECTOR

AstraZeneca KK

Locations

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Research Site

Aichi, , Japan

Site Status

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Akita, , Japan

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Aomori, , Japan

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Chiba, , Japan

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Fukui, , Japan

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Fukuoka, , Japan

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Gifu, , Japan

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Gunma, , Japan

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Hiroshima, , Japan

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Hokkaido, , Japan

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Hyōgo, , Japan

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Ibaraki, , Japan

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Ishikawa, , Japan

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Kagawa, , Japan

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Kanagawa, , Japan

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Kumamoto, , Japan

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Kyoto, , Japan

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Mie, , Japan

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Miyagi, , Japan

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Nara, , Japan

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Numakunai, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Ōita, , Japan

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Saitama, , Japan

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Shimane, , Japan

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Shizuoka, , Japan

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Tochigi, , Japan

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Tokyo, , Japan

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Toyama, , Japan

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Wakayama, , Japan

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Yamagata, , Japan

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Yamaguchi, , Japan

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Yamanashi, , Japan

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Countries

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Japan

Other Identifiers

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D5180C00034

Identifier Type: -

Identifier Source: org_study_id