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Active, not recruitingNCT06427876Updated Sep 10, 2026

Fasenra Pediatric Japan Post-Marketing Study(PMS)

An observational study in Bronchial Asthma, sponsored by AstraZeneca. Active, not recruiting at 9 sites in Japan. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Sex
All
01

Study summary

The purpose of the investigation is to confirm the followings under the post-marketing actual use of Fasenra® Subcutaneous Injection 30 mg / 10mg Syringe (hereinafter referred to as Fasenra).

  1. Development of unexpected related AEs*
  2. To grasp development of related AEs* in the real-world post-marketing setting.
  3. Effectiveness (pulmonary function and asthma control) * AEs investigator or MAH considers that there is a reasonable possibility that the experience may have been caused by the drug
Read the detailed description

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.

The purpose of the investigation is to confirm the followings under the post-marketing actual use of Fasenra® Subcutaneous Injection 30 mg / 10mg Syringe (hereinafter referred to as Fasenra).

  1. Development of unexpected related AEs*
  2. To grasp development of related AEs* in the real-world post-marketing setting.
  3. Effectiveness (pulmonary function and asthma control) * AEs investigator or MAH considers that there is a reasonable possibility that the experience may have been caused by the drug
02

Conditions studied

  • Bronchial Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 40 is below the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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)

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

Exclusion Criteria:

none

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Incidence of ADRs

    The incidence of ADRs related to Fasenra Safety Specification, Serious infection and other

    Time frame: from baseline to 1year

07

Study locations

9 sites
  • Research Site
    Chiba, Japan
  • Research Site
    Hiroshima, Japan
  • Research Site
    Hokkaido, Japan
  • Research Site
    Hyōgo, Japan
  • Research Site
    Ibaraki, Japan
  • Research Site
    Mie, Japan
  • Research Site
    Okayama, Japan
  • Research Site
    Osaka, Japan
  • Research Site
    Saitama, Japan
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06427876
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
May 24, 2024
Start date
Jul 16, 2024
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 10, 2026

Study contacts

Shunsuke Hiroki
study director · AstraZeneca

Oversight

FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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