FASENRA SCEI for Long-term Use

August 26, 2025 updated by: AstraZeneca

FASENRA Subcutaneous Injection 30 mg Syringe Specific Clinical Experience Investigation for Long-term Use

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

653

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan, D3250C00057
        • Research Site
      • Akita, Japan, D3250C00057
        • Research Site
      • Aomori, Japan, D3250C00057
        • Research Site
      • Chiba, Japan, D3250C00057
        • Research Site
      • Ehime, Japan, D3250C00057
        • Research Site
      • Fukuoka, Japan, D3250C00057
        • Research Site
      • Gunma, Japan, D3250C00057
        • Research Site
      • Hiroshima, Japan, D3250C00057
        • Research Site
      • Hokkaido, Japan, D3250C00057
        • Research Site
      • Hyōgo, Japan, D3250C00057
        • Research Site
      • Ibaraki, Japan, D3250C00057
        • Research Site
      • Kagawa, Japan, D3250C00057
        • Research Site
      • Kagoshima, Japan, D3250C00057
        • Research Site
      • Kanagawa, Japan, D3250C00057
        • Research Site
      • Kumamoto, Japan, D3250C00057
        • Research Site
      • Kyoto, Japan, D3250C00057
        • Research Site
      • Mie, Japan, D3250C00057
        • Research Site
      • Miyagi, Japan, D3250C00057
        • Research Site
      • Numakunai, Japan, D3250C00057
        • Research Site
      • Okayama, Japan, D3250C00057
        • Research Site
      • Okinawa, Japan, D3250C00057
        • Research Site
      • Osaka, Japan, D3250C00057
        • Research Site
      • Saitama, Japan, D3250C00057
        • Research Site
      • Shiga, Japan, D3250C00057
        • Research Site
      • Tochigi, Japan, D3250C00057
        • Research Site
      • Tokyo, Japan, D3250C00057
        • Research Site
      • Yamagata, Japan, D3250C00057
        • Research Site
      • Yamaguchi, Japan, D3250C00057
        • Research Site
      • Ōita, Japan, D3250C00057
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The 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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidences of adverse drug reactions (ADRs) [all ADRS, unexpected ADRs and key investigational safety specification (serious infection)]
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Change scores from baseline in Asthma Control Questionnaire (ACQ) with exploring a factor to affect them by patient's background and treatment condition
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Toshimitsu Tokimoto, Astrazeneca KK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2018

Primary Completion (Actual)

September 10, 2024

Study Completion (Actual)

September 10, 2024

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

July 4, 2018

First Posted (Actual)

July 17, 2018

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3250C00057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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