Clinical trial NCT06427876: Fasenra Pediatric Japan Post-Marketing Study(PMS)
Official title: FASENRA® Subcutaneous Injection 30 mg / 10mg Syringe Protocol of Specific Drug Use Result Study for Pediatric Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchial Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-05-24
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

Brief 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

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

Eligibility 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

Primary outcomes:
measure: Incidence of ADRs
timeFrame: from baseline to 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Mie
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Shunsuke Hiroki
role: STUDY_DIRECTOR
References: