Clinical trial NCT05091333: FASENRA Regulatory Postmarketing Surveillance in Korea
Official title: FASENRA Regulatory Postmarketing Surveillance in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma, EGPA(Eosinophilic Granulomatosis With Polyangiitis)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-10-25
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Detailed description: This is a local, prospective, non-interventional, observational study is designed to evaluate safety and effectiveness of FASENRA in real world clinical practice setting in Korea. Adult patients with severe eosinophilic asthma and/or eosinophilic granulomatosis with polyangiitis (EGPA) who are initiating FASENRA for the first time as indicated by the MFDS will be included. At least 45 patients are followed for up 24 weeks and/or 48 weeks.

Patients will be treated as part of routine practice at Korean healthcare centers by accredited physicians. Each investigator will sequentially enroll patients who are initiating FASENRA for the first time and receive at least one dose until the target number of patients per center is reached. The characteristics of the study population and the FASENRA treatment schedule should be consistent with those described in the local product information at the time of enrolment (as the local product information may change). The study will enrol patients until the target number is reached.

All patients will be evaluated for safety during FASENRA use or for 30 days after their last dose of the surveillance drug if patients discontinued FASENRA before 24 weeks. Investigator's follow up of adverse events can be conducted by mail, phone calls, or e-mail for patients who discontinue early. The decision about the duration and discontinuation of treatment is solely at the discretion of the treating investigator with agreement of the patient.

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

Primary outcomes:
measure: Percentage (%) of AEs and SAEs in patients who are treated with FASENRA
timeFrame: 24 or 48 weeks
measure: Nature (type) of AEs in patients who are treated with FASENRA
timeFrame: 24 or 48 weeks
measure: Incidence of AEs in patients who are treated with FASENRA
timeFrame: 24 or 48 weeks
measure: Severity of AEs in patients who are treated with FASENRA
timeFrame: 24 or 48 weeks
measure: Nature of unexpected adverse drug reactions in patients who are treated with FASENRA
timeFrame: 24 or 48 weeks
measure: Incidence of unexpected adverse drug reactions in patients who are treated with FASENRA
timeFrame: 24 or 48 weeks
measure: Severity of unexpected adverse drug reactions in patients who are treated with FASENRA
timeFrame: 24 or 48 weeks
Secondary outcomes:
measure: Number of exacerbation
timeFrame: 24 or 48 weeks
measure: Numbers of hospitalizations or ER visits due to asthma exacerbation
timeFrame: 24 or 48 weeks
measure: Overall investigator's assessment on the outcome of the treatment: "Well control", "Partly control", "Uncontrolled"
timeFrame: 24 or 48 weeks
measure: Overall investigator's assessment on any of the criteria below
timeFrame: 24 or 48 weeks
Other outcomes:
measure: Pre-bronchodilator FEV1(mL), if available
timeFrame: 24 or 48 weeks
measure: Peripheral blood eosinophil count, if available
timeFrame: 24 or 48 weeks
measure: FeNO, if available
timeFrame: 24 or 48 weeks
Locations:
city: Busan
country: Korea, Republic of
facility: Research Site
city: Gangneung-si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon-si
country: Korea, Republic of
facility: Research Site
city: Ulsan
country: Korea, Republic of
facility: Research Site
Study officials:
References: