Asthma, EGPA(Eosinophilic Granulomatosis With Polyangiitis)FASENRA rPMSNCT05091333
FASENRA Regulatory Postmarketing Surveillance in Korea
An observational study of Asthma, EGPA(Eosinophilic Granulomatosis With Polyangiitis), run by AstraZeneca at 5 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, EGPA(Eosinophilic Granulomatosis With Polyangiitis)
- How many people
- 51 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 11 Mar 2022to 6 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Hypersensitivity to the active substances or to any of the excipients
- Current participation in any interventional trial
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Research Site
Busan
Research Site
Gangneung-si
Research Site
Seoul
Research Site
Suwon
Research Site
Ulsan
About this study
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.
Read the 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.
- Medical subject headings
- Asthma, Churg-Strauss Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage (%) of AEs and SAEs in patients who are treated with FASENRA
Measured: 24 or 48 weeks
Nature (type) of AEs in patients who are treated with FASENRA
Measured: 24 or 48 weeks
Incidence of AEs in patients who are treated with FASENRA
Measured: 24 or 48 weeks
Severity of AEs in patients who are treated with FASENRA
Measured: 24 or 48 weeks
Nature of unexpected adverse drug reactions in patients who are treated with FASENRA
Measured: 24 or 48 weeks
Incidence of unexpected adverse drug reactions in patients who are treated with FASENRA
Measured: 24 or 48 weeks
Severity of unexpected adverse drug reactions in patients who are treated with FASENRA
Measured: 24 or 48 weeks
Secondary outcomes (4)
Number of exacerbation
Measured: 24 or 48 weeks
Numbers of hospitalizations or ER visits due to asthma exacerbation
Measured: 24 or 48 weeks
Overall investigator's assessment on the outcome of the treatment: "Well control", "Partly control", "Uncontrolled"
Measured: 24 or 48 weeks
Overall investigator's assessment on any of the criteria below
EGPA Remission (defined as BVAS = 0 and prednisolone/prednisone dose ≤ 4 mg/day)
≥ 50% reduction in average daily prednisolone/prednisone dose EGPA relapse free during treatment period
Measured: 24 or 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start11 Mar 2022
- Primary completion6 Mar 2025
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, EGPA(Eosinophilic Granulomatosis With Polyangiitis)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091333
- Sponsor's protocol ID
- D3250R00043
- Acronym
- FASENRA rPMS
- Status last verified
- Feb 2026
- First submitted
- 30 Sep 2021
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FASENRA Regulatory Postmarketing Surveillance in Korea
- ClinicalTrials.gov ID
- NCT05091333
- Acronym / sponsor ID
- FASENRA rPMS / D3250R00043
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Hypersensitivity to the active substances or to any of the excipients
- Current participation in any interventional trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage (%) of AEs and SAEs in patients who are treated with FASENRA
Time frame: 24 or 48 weeks
Nature (type) of AEs in patients who are treated with FASENRA
Time frame: 24 or 48 weeks
Incidence of AEs in patients who are treated with FASENRA
Time frame: 24 or 48 weeks
Severity of AEs in patients who are treated with FASENRA
Time frame: 24 or 48 weeks
Nature of unexpected adverse drug reactions in patients who are treated with FASENRA
Time frame: 24 or 48 weeks
Incidence of unexpected adverse drug reactions in patients who are treated with FASENRA
Time frame: 24 or 48 weeks
Severity of unexpected adverse drug reactions in patients who are treated with FASENRA
Time frame: 24 or 48 weeks
4 secondary outcomes
Number of exacerbation
Time frame: 24 or 48 weeks
Numbers of hospitalizations or ER visits due to asthma exacerbation
Time frame: 24 or 48 weeks
Overall investigator's assessment on the outcome of the treatment: "Well control", "Partly control", "Uncontrolled"
Time frame: 24 or 48 weeks
Overall investigator's assessment on any of the criteria below
Time frame: 24 or 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, EGPA(Eosinophilic Granulomatosis With Polyangiitis), run by AstraZeneca at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage (%) of AEs and SAEs in patients who are treated with FASENRA (time frame: 24 or 48 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.