AsthmaNCT03588546

FASENRA SCEI for Long-term Use

An observational study of Asthma, run by AstraZeneca at 29 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Asthma
How many people: 653 participants
Where: 29 sitesJapan
Study dates: 31 May 2018to 10 Sep 2024
How long will I take part?: 1 Year
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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).

Who may be able to join

-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).

Who cannot join

-No past history of hypersensitivity to the components of Fasenra.

Trial locations and contacts

29 sites in 1 country.

City, postcode or hospital

29 sites in 1 country

Japan29 sites

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

Other trials in Japan

About this study

Official title: 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.

Read the 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.

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

Conditions: Asthma
Keywords: Fasenra Benralizumab Bronchial asthma
Medical subject headings: Asthma

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 201810 Sep 2024

First posted17 Jul 2018
Study start31 May 2018
Primary completion10 Sep 2024
Study completion10 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 653 participants (actual)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT03588546
Sponsor's protocol ID: D3250C00057
Status last verified: Aug 2025
First submitted: 25 May 2018
Last updated: 2 Sep 2025
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: FASENRA Subcutaneous Injection 30 mg Syringe Specific Clinical Experience Investigation for Long-term Use
ClinicalTrials.gov ID: NCT03588546
Acronym / sponsor ID: D3250C00057
Conditions: Asthma
Keywords: Fasenra Benralizumab Bronchial asthma
Study type: Observational
Recruitment status: Completed
Enrolment: 653 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 31 May 2018 (actual)
Primary completion: 10 Sep 2024 (actual)
Study completion: 10 Sep 2024 (actual)
First posted: 17 Jul 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Year

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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).

Key inclusion criteria (1 listed)

-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).

Key exclusion criteria (1 listed)

-No past history of hypersensitivity to the components of Fasenra.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
CSR SynopsisLink provided by the sponsor.

Related trials for Asthma

RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Toshimitsu Tokimoto study director

AstraZeneca KK

29 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by AstraZeneca at 29 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidences of adverse drug reactions (ADRs) [all ADRS, unexpected ADRs and key investigational safety specification (serious infection)] (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03588546.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.