CompletedNot Applicable

FASENRA Regulatory Postmarketing Surveillance in Korea

South Korea51 participantsStarted 2022-03-11

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients aged 18 years and older
. 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
. 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

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage (%) of AEs and SAEs in patients who are treated with FASENRA

Timeframe: 24 or 48 weeks

Nature (type) of AEs in patients who are treated with FASENRA

Timeframe: 24 or 48 weeks

Incidence of AEs in patients who are treated with FASENRA

Timeframe: 24 or 48 weeks

Severity of AEs in patients who are treated with FASENRA

Timeframe: 24 or 48 weeks

Nature of unexpected adverse drug reactions in patients who are treated with FASENRA

Timeframe: 24 or 48 weeks

Incidence of unexpected adverse drug reactions in patients who are treated with FASENRA

Timeframe: 24 or 48 weeks

Severity of unexpected adverse drug reactions in patients who are treated with FASENRA

Timeframe: 24 or 48 weeks

Trial details

NCT IDNCT05091333

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-03-06

View on ClinicalTrials.gov More Asthma, EGPA(Eosinophilic Granulomatosis With Polyangiitis) trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients aged 18 years and older
. 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
. 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

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

What they're measuring

Percentage (%) of AEs and SAEs in patients who are treated with FASENRA

Timeframe: 24 or 48 weeks

Nature (type) of AEs in patients who are treated with FASENRA

Timeframe: 24 or 48 weeks

Incidence of AEs in patients who are treated with FASENRA

Timeframe: 24 or 48 weeks

Severity of AEs in patients who are treated with FASENRA

Timeframe: 24 or 48 weeks

Nature of unexpected adverse drug reactions in patients who are treated with FASENRA

Timeframe: 24 or 48 weeks

Incidence of unexpected adverse drug reactions in patients who are treated with FASENRA

Timeframe: 24 or 48 weeks

Severity of unexpected adverse drug reactions in patients who are treated with FASENRA

Timeframe: 24 or 48 weeks