The Improvement of lung function after long-term use of Dupilumab in Korean severe asthma patients

Asan Medical Center0 个研究点目标入组 222 人开始时间: 待定最近更新: 2022年11月28日

试验速览

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•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%

•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

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