Fasenra Pediatric Japan Post-Marketing Study(PMS)

AstraZeneca

Status: Enrolling

Conditions: Bronchial Asthma

Study type: Observational

Funder types: Industry

Identifiers

NCT06427876

D3250C00100

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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