FASENRA SCEI for Long-term Use

NCT ID: NCT03588546

Last Updated: 2025-09-02

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

COMPLETED

Total Enrollment

653 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-31

Study Completion Date

2024-09-10

Brief Summary

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The purpose of the investigation is to confirm the safety and efficacy under the post-marketing actual long-term use of FASENRA Subcutaneous Injection 30 mg Syringe.

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 FASENRA Subcutaneous Injection 30 mg Syringe.

1. Detection of unexpected Adverse Drug Reactions
2. To grasp development of Adverse Drug Reactions
3. To grasp contributing factors possibly having an impact on the safety and efficacy
4. Development of key investigational safety specification (serious infection).

Conditions

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Asthma

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 treated with Fasenra for the first time due to "Bronchial asthma (only the patients with intractable bronchial asthma which could not be controlled with the existing therapy).

Exclusion Criteria

-No past history of hypersensitivity to the components of Fasenra.
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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Ehime, , Japan

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Fukuoka, , 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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Kagawa, , Japan

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Kagoshima, , 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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Numakunai, , Japan

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Okayama, , Japan

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Okinawa, , Japan

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Osaka, , Japan

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Ōita, , Japan

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Saitama, , Japan

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Shiga, , Japan

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Tochigi, , Japan

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Tokyo, , Japan

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Yamagata, , Japan

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Yamaguchi, , Japan

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Countries

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Japan

Other Identifiers

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D3250C00057

Identifier Type: -

Identifier Source: org_study_id

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