Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000361

EU PAS number

EUPAS1000000361

Study ID

1000000361

Official title and acronym

Comparative effectiveness and safety of omalizumab and dupilumab in children with asthma

DARWIN EU® study

No

Study countries

Korea, Republic of

Study description

This study is a cohort study which aims to:
1) Compare the effectiveness of omalizumab and dupilumab in pediatric asthma patients.
2) Compare the incidence of previously known side effects of omalizumab and dupilumab in pediatric asthma patients.

AIM 1) Comparative Effectiveness
- Determine and compare the incidence rate of asthma exacerbation in asthma patients on either omalizumab or dupilumab.
- Compare how much reduction of steroid use was achieved in asthma patients on either omalizumab or dupilumab.

AIM 2) Comparative Safety
- Determine and compare the incidence rate of previously known side effects of omalizumab and dupilumab, including eosinophilia, helminth infection, anaphylaxis, and conjunctivitis.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Seng Chan You

Primary lead investigator
ORCID number:
0000-0002-5052-6399
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding

More details on funding

This research was supported by a grant of the MD-Phd/Medical Scientist Training Program through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea.
Study protocol
Initial protocol

BiologicsCDM_Research Protocol

English (352.98 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable