The safety evaluation of severe asthma treated with Mepolizumab in Korea
- Conditions
- Diseases of the respiratory system
- Registration Number
- KCT0006374
- Lead Sponsor
- Hanyang University Seoul Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 50
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)
(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)
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse reaction
- Secondary Outcome Measures
Name Time Method severe adverse reaction