FASENRA Regulatory Postmarketing Surveillance in Korea

Asthma Clinical Trial

Official title:

FASENRA Regulatory Postmarketing Surveillance in Korea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05091333
• Other study ID #: D3250R00043
• Status: Recruiting
• Start date: March 11, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 asthma with an eosinophilic phenotype 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.

This study will provide information on the Korean patient population that is treated with this drug.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	GangNeung
Korea, Republic of	Research Site	Gangwon Do	South Korea
Korea, Republic of	Research Site	Gwangju
Korea, Republic of	Research Site	Gyeonggi do
Korea, Republic of	Research Site	Gyeonggi do
Korea, Republic of	Research Site	Jeonju
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon si
Korea, Republic of	Research Site	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pre-bronchodilator FEV1(mL), if available		24 or 48 weeks
Other	Peripheral blood eosinophil count, if available		24 or 48 weeks
Other	FeNO, if available		24 or 48 weeks
Primary	Percentage (%) of AEs and SAEs in patients who are treated with FASENRA		24 or 48 weeks
Primary	Nature (type) of AEs in patients who are treated with FASENRA		24 or 48 weeks
Primary	Incidence of AEs in patients who are treated with FASENRA		24 or 48 weeks
Primary	Severity of AEs in patients who are treated with FASENRA		24 or 48 weeks
Primary	Nature of unexpected adverse drug reactions in patients who are treated with FASENRA		24 or 48 weeks
Primary	Incidence of unexpected adverse drug reactions in patients who are treated with FASENRA		24 or 48 weeks
Primary	Severity of unexpected adverse drug reactions in patients who are treated with FASENRA		24 or 48 weeks
Secondary	Number of exacerbation		24 or 48 weeks
Secondary	Numbers of hospitalizations or ER visits due to asthma exacerbation		24 or 48 weeks
Secondary	Overall investigator's assessment on the outcome of the treatment: "Well control", "Partly control", "Uncontrolled"		24 or 48 weeks