None listed
Conditions
Interventions
None listed
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with severe asthma between the ages of 18 and 80 who are scheduled to receive dupilumab 2) Diagnosed as asthma by a specialist and has severe asthma according to the 2014 ATS/ERS guidelines; - Patients who need to use high-dose inhaled steroids and additional modulators for symptom control or systemic steroids for more than 50% of the year. Or when asthma is not controlled by the drug. Here, uncontrolled asthma means any of the following: a. ACT score less than 20 or ‘not well controlled’ according to the GINA guideline b. frequent exacerbations; 2 or more systemic steroid administration (3 consecutive days or more) required in the previous year c. severe exacerbation; At least one exacerbation that required hospitalization, intensive care unit admission, or ventilator application in the preceding year d. airflow limitation; FEV1 < 80%
Exclusion criteria
Exclusion criteria: 1) Minors under the age of 18, senior citizens over 80 years of age 2) If there is a history of using other biological products within 3 months prior to study registration 3) In case of acute exacerbation that required steroid administration of steroid burst (total 90mg prednisolone or more) during the screening period of 4 weeks prior to study registration (possible for long-term prednisolone users) 4) In case of clinically serious respiratory disease in addition to severe asthma 5) Hypereosinophilic syndrome, ABPA, EGPA accompanied 6) When it is difficult to evaluate asthma alone due to severe respiratory disease 7) Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of lung function (FEV1) after treatment with Dupilumab | — |
Secondary
| Measure | Time frame |
|---|---|
| frequency of annual asthma exacerbation;inflammation marker (blood eosinophil count, fractional exhaled nitric oxide);changes in questionnaire (ACT, QLQAKA, Severe Asthma Questionnaire (SAQ), Euro-QoL-5D, Cough Questionnaire for Asthma, SNOT-22) | — |
Countries
Korea, Republic of
Contacts
Public ContactYuri Kang
Asan Medical Center
Outcome results
None listed