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 range18 Years

SexALL

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

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 range18 Years

SexALL

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