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FASENRA Regulatory Postmarketing Surveillance in Korea

CompletedN/A

Sponsor: AstraZeneca

Conditions: Asthma, EGPA(Eosinophilic Granulomatosis With Polyangiitis)

Countries: South Korea

As part of a post approval commitment, the MFDS has requested a study to characterize safety in patients who are treated with FASENRA for severe eosinophilic asthma and/or eosinophilic granulomatosis with polyangiitis (EGPA) by physicians in normal clinical practice settings. This study is designed to confirm or assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of FASENRA under conditions of routine daily medical practice in Korea.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Patients aged 18 years and older
2. Patients with severe asthma with an eosinophilic phenotype eligible for first time treatment with FASENRA according to the indication as indicated in the locally approved prescribing information
3. Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

1. Hypersensitivity to the active substances or to any of the excipients
2. Current participation in any interventional trial

Locations (5)

Busan, South Korea
Gangneung-si, South Korea
Seoul, South Korea
Suwon, South Korea
Ulsan, South Korea