Bronchial Asthma (Only the Patients With Severe or Intractable Bronchial Asthma Which Could Not be Controlled With the Existing Therapy)NCT05729711

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

An observational study of Bronchial Asthma (Only the Patients With Severe or Intractable Bronchial Asthma Which Could Not be Controlled With the Existing Therapy), run by AstraZeneca at 33 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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 Read more about this study

Who is it for?: Any age
Conditions the study is for: Bronchial Asthma (Only the Patients With Severe or Intractable Bronchial Asthma Which Could Not be Controlled With the Existing Therapy)
How many people: 416 participants
Where: 33 sitesJapan
Study dates: 4 Apr 2023to 16 Nov 2029
Phase: Observational
Are there results?: Not yet: the study is under way

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 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)

Who may be able to join

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)

Who cannot join

None

Trial locations and contacts

33 sites in 1 country.

City, postcode or hospital

33 sites in 1 country

Japan33 sites

Research Site
Aichi
Research Site
Akita
Research Site
Aomori
Research Site
Chiba
Research Site
Fukui
Research Site
Fukuoka
Research Site
Gifu
Research Site
Gunma
Research Site
Hiroshima
Research Site
Hokkaido
Research Site
Hyōgo
Research Site
Ibaraki
Research Site
Ishikawa
Research Site
Kagawa
Research Site
Kanagawa
Research Site
Kumamoto
Research Site
Kyoto
Research Site
Mie
Research Site
Miyagi
Research Site
Nara
Research Site
Numakunai
Research Site
Ōita
Research Site
Okayama
Research Site
Osaka
Research Site
Saitama
Research Site
Shimane
Research Site
Shizuoka
Research Site
Tochigi
Research Site
Tokyo
Research Site
Wakayama
Research Site
Yamagata
Research Site
Yamaguchi
Research Site
Yamanashi

Other trials in Japan

About this study

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

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

Read the detailed description

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.

Conditions: Bronchial Asthma (Only the Patients With Severe or Intractable Bronchial Asthma Which Could Not be Controlled With the Existing Therapy)
Medical subject headings: Asthma

What is being measured

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

Incidence of ADRs
the incidence of ADRs related to Tezspire Safety Specifications: Serious hypersensitivity, infection, malignancy, cardiac disorders
Measured: 156 weeks

Timeline

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

4 Apr 202316 Nov 2029

First posted15 Feb 2023
Study start4 Apr 2023
Primary completion16 Nov 2029 (estimated)
Study completion16 Nov 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bronchial Asthma (Only the Patients With Severe or Intractable Bronchial Asthma Which Could Not be Controlled With the Existing Therapy)Studies 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: 416 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05729711
Sponsor's protocol ID: D5180C00034
Status last verified: Sep 2026
First submitted: 7 Feb 2023
Last updated: 29 Sep 2026
Results posted: No
FDA-regulated drug: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TEZSPIRE Subcutaneous Injection 210mg Specific Use-results Study (Long Term) in Patients With Bronchial Asthma.
ClinicalTrials.gov ID: NCT05729711
Acronym / sponsor ID: D5180C00034
Conditions: Bronchial Asthma (Only the Patients With Severe or Intractable Bronchial Asthma Which Could Not be Controlled With the Existing Therapy)
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 416 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 4 Apr 2023 (actual)
Primary completion: 16 Nov 2029 (estimated)
Study completion: 16 Nov 2029 (estimated)
First posted: 15 Feb 2023 (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 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

Detailed description

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

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

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

Key inclusion criteria (1 listed)

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)

Key exclusion criteria (1 listed)

None

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

Incidence of ADRs
Time frame: 156 weeks
the incidence of ADRs related to Tezspire Safety Specifications: Serious hypersensitivity, infection, malignancy, cardiac disorders

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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

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

Questions about this trial

What is this clinical trial studying?

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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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?

This study is still under way. Results are not available in the source record yet.

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?

Incidence of ADRs (time frame: 156 weeks). 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 NCT05729711.

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 29 Sep 2026.