Long-term use of Tezspire for severe asthma in Japan
TEZSPIRE Subcutaneous Injection 210mg Specific Use-results Study (Long Term) in Patients With Bronchial Asthma.
This study is testing how safe and effective Tezspire is for people in Japan with severe asthma that isn't well controlled by other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 62 sites (Aichi and 61 other locations) |
| Trial ID | NCT05729711 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the long-term safety and effectiveness of Tezspire (tezepelumab) in patients with severe or intractable bronchial asthma that is not controlled by existing therapies. It will assess the development of related adverse events (AEs) and identify factors that may influence the treatment's safety and effectiveness. The findings will support regulatory re-examination under Japanese pharmaceutical law.
Who should consider this trial
Good fit: Ideal candidates are patients in Japan with severe or intractable bronchial asthma who are starting treatment with Tezspire for the first time.
Not a fit: Patients with mild or well-controlled asthma are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of Tezspire for patients with severe asthma.
How similar studies have performed: Other studies on Tezspire have shown promising results, indicating its potential effectiveness in managing severe asthma.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aichi and 61 other locations
- Research Site — Aichi, Japan (Active_not_recruiting)
- Research Site — Aichi, Japan (Recruiting)
- Research Site — Akita, Japan (Active_not_recruiting)
- Research Site — Aomori, Japan (Active_not_recruiting)
- Research Site — Chiba, Japan (Recruiting)
- Research Site — Chiba, Japan (Active_not_recruiting)
- Research Site — Fukui, Japan (Active_not_recruiting)
- Research Site — Fukuoka, Japan (Active_not_recruiting)
- Research Site — Fukuoka, Japan (Recruiting)
- Research Site — Gifu, Japan (Recruiting)
- Research Site — Gifu, Japan (Withdrawn)
- Research Site — Gunma, Japan (Withdrawn)
- Research Site — Gunma, Japan (Active_not_recruiting)
- Research Site — Hiroshima, Japan (Active_not_recruiting)
- Research Site — Hiroshima, Japan (Recruiting)
- Research Site — Hokkaido, Japan (Active_not_recruiting)
- Research Site — Hokkaido, Japan (Recruiting)
- Research Site — Hyogo, Japan (Active_not_recruiting)
- Research Site — Hyogo, Japan (Recruiting)
- Research Site — Ibaraki, Japan (Recruiting)
- Research Site — Ibaraki, Japan (Active_not_recruiting)
- Research Site — Ishikawa, Japan (Active_not_recruiting)
- Research Site — Iwate, Japan (Recruiting)
- Research Site — Iwate, Japan (Active_not_recruiting)
- Research Site — Kagawa, Japan (Recruiting)
- Research Site — Kanagawa, Japan (Recruiting)
- Research Site — Kanagawa, Japan (Active_not_recruiting)
- Research Site — Kumamoto, Japan (Active_not_recruiting)
- Research Site — Kumamoto, Japan (Recruiting)
- Research Site — Kyoto, Japan (Recruiting)
- Research Site — Kyoto, Japan (Active_not_recruiting)
- Research Site — Mie, Japan (Withdrawn)
- Research Site — Mie, Japan (Active_not_recruiting)
- Research Site — Miyagi, Japan (Active_not_recruiting)
- Research Site — Miyagi, Japan (Recruiting)
- Research Site — Nara, Japan (Active_not_recruiting)
- Research Site — Nara, Japan (Recruiting)
- Research Site — Oita, Japan (Active_not_recruiting)
- Research Site — Oita, Japan (Recruiting)
- Research Site — Okayama, Japan (Recruiting)
- Research Site — Osaka, Japan (Withdrawn)
- Research Site — Osaka, Japan (Active_not_recruiting)
- Research Site — Osaka, Japan (Recruiting)
- Research Site — Saitama, Japan (Recruiting)
- Research Site — Saitama, Japan (Active_not_recruiting)
- Research Site — Saitama, Japan (Withdrawn)
- Research Site — Shimane, Japan (Active_not_recruiting)
- Research Site — Shimane, Japan (Recruiting)
- Research Site — Shizuoka, Japan (Active_not_recruiting)
- Research Site — Shizuoka, Japan (Recruiting)
+12 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.