Actively Recruiting
FASENRA® Subcutaneous Injection 30 mg / 10mg Syringe Post-Marketing Study for Pediatric Patients with Bronchial Asthma
Led by AstraZeneca · Updated on 2026-05-27
40
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the real-world use of Fasenra® Subcutaneous Injection 30 mg / 10 mg Syringe in children with bronchial asthma who have not responded to existing treatments. The study focuses on monitoring the development of unexpected adverse events that may be related to the drug, as well as tracking known adverse events in a post-marketing setting. Additionally, the study will assess the drug's effectiveness in improving lung function and asthma control. Participants in this observational study are children aged 6 to under 15 years who are receiving Fasenra for the first time due to difficult-to-control bronchial asthma. There is no intervention or randomization involved since this is a post-marketing surveillance study. The study will collect data during regular treatment and follow-up visits as the drug is used in typical clinical practice. Participants will be monitored for up to one year to record any adverse drug reactions and to evaluate asthma control and pulmonary function. The main outcome measured is the incidence of adverse drug reactions from the start of treatment through one year. Researchers will gather information from medical records and routine clinical assessments to understand the drug’s safety and effectiveness over this period.
CONDITIONS
Brief Title
Fasenra Pediatric Japan Post-Marketing Study(PMS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 years to under 15 years
- Diagnosed with bronchial asthma that is difficult to control with existing therapies
- Starting Fasenra treatment for the first time
You will not qualify if you...
- None specified
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants who undergo routine care with Fasenra are observed to confirm safety and effectiveness in a real-world post-marketing setting.
Regular visits as part of routine care
Trial Site Locations
Total: 13 locations
1
Research Site
Aichi, Japan
Actively Recruiting
2
Research Site
Chiba, Japan
Actively Recruiting
3
Research Site
Hiroshima, Japan
Actively Recruiting
4
Research Site
Hokkaido, Japan
Actively Recruiting
5
Research Site
Hyōgo, Japan
Actively Recruiting
6
Research Site
Ibaraki, Japan
Active, Not Recruiting
7
Research Site
Ibaraki, Japan
Actively Recruiting
8
Research Site
Kumamoto, Japan
Not Yet Recruiting
9
Research Site
Mie, Japan
Actively Recruiting
10
Research Site
Okayama, Japan
Actively Recruiting
11
Research Site
Osaka, Japan
Active, Not Recruiting
12
Research Site
Osaka, Japan
Actively Recruiting
13
Research Site
Saitama, Japan
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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