Actively Recruiting

All Genders
ID06427876

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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • None specified

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

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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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