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The safety evaluation of severe asthma treated with Mepolizumab in Korea

The safety evaluation of severe asthma treated with Mepolizumab in Korea

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0006374
Enrollment
50
Registered
2021-07-22
Start date
2021-06-15
Completion date
Unknown
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Hanyang University Seoul Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who receive mepolizumab for treatment among patients with severe asthma, and severe asthma is defined as one or more of the following: 1) Patients with poor asthma control despite receiving step 4 or step 5 treatment according to the definition of the GINA guideline 2) Even if it is controlled well while receiving step 4 or step 5 treatment at the time of the investigation, it falls under one or more of the following cases: (a) Visiting an emergency room, hospitalization or outpatient due to asthma exacerbation at least once a year; (b) systemic steroids are required at least three times a year (at 15 mg/day per prednisolone for at least three days); (c) Immediately asthma worsens when oral or ICS dose is reduced by less than 25%; (d) If you have had a very fatal asthma attack in the past (in intensive care or intubation)

Exclusion criteria

Exclusion criteria: (1) bronchiectasis (except mild) (2) TB destroyed lung (3) interstitial lung disease (4) chronic respiratory disease other than asthma (Tuberculosis, active infectious disease, etc.) (5) severe psychiatric disorders that can impair research, such as schizophrenia (6) severe congestive heart failure (7) Other serious systemic diseases (ESRD on hemodialysis, severe liver disease) (8) continuous systemic steroid user due to other disease control (9) If the life expectancy is less than 3 years due to malignancy (patients in remission for =5 years could be included)

Design outcomes

Primary

MeasureTime frame
Adverse reaction

Secondary

MeasureTime frame
severe adverse reaction

Countries

Korea, Republic of

Contacts

Public ContactSo-Young Park

Chung-Ang University Gwangmyeong Hospital

raina821563@gmail.com+82-2-2030-7638

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026