Observational study on Fasenra for pediatric bronchial asthma in Japan
FASENRA® Subcutaneous Injection 30 mg / 10mg Syringe Protocol of Specific Drug Use Result Study for Pediatric Patients
This study is testing how well Fasenra works and its safety for children aged 6 to 14 with hard-to-treat asthma in Japan.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 11 sites (Aichi and 10 other locations) |
| Trial ID | NCT06427876 on ClinicalTrials.gov |
What this trial studies
This investigation aims to evaluate the real-world use of Fasenra® in children aged 6 to 14 years with intractable bronchial asthma. It focuses on monitoring the development of unexpected adverse events (AEs) and assessing the drug's effectiveness in improving pulmonary function and asthma control. The study is conducted under post-marketing conditions to gather data that supports regulatory re-examination of the medication. The findings will help understand the safety and efficacy of Fasenra in a pediatric population.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 14 years who are receiving Fasenra for the first time due to intractable bronchial asthma.
Not a fit: Patients who do not have intractable bronchial asthma or are outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of Fasenra for children with difficult-to-treat asthma.
How similar studies have performed: Other studies on Fasenra have shown promising results in adult populations, but this specific pediatric investigation is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The evaluable patients in children aged ≥6 years to \<15 years are those 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: none
Where this trial is running
Aichi and 10 other locations
- Research Site — Aichi, Japan (Recruiting)
- Research Site — Chiba, Japan (Recruiting)
- Research Site — Hiroshima, Japan (Active_not_recruiting)
- Research Site — Hokkaido, Japan (Recruiting)
- Research Site — Hyōgo, Japan (Recruiting)
- Research Site — Ibaraki, Japan (Active_not_recruiting)
- Research Site — Mie, Japan (Recruiting)
- Research Site — Okayama, Japan (Recruiting)
- Research Site — Osaka, Japan (Active_not_recruiting)
- Research Site — Osaka, Japan (Recruiting)
- Research Site — Saitama, Japan (Recruiting)
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.