A prospective study that examines changes in lung function and analyzes samples in patients with severe asthma who will receive biologics to identify factors affecting changes in lung function and treatment response through omics analysis

Not Applicable

Conditions: Diseases of the respiratory system

Registration Number: KCT0006967

Lead Sponsor: Asan Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 60

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 even with the drug. Here, uncontrolled asthma means any of the following:
a. ACT score less than 20 or ‘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

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 before research 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

Study & Design

Study Type: Observational Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ACT, QLQAKA, Severe Asthma Questionnaire, Euro-QoL-5D, Cough Questionnaire for Asthma (CQA), SNOT-22, PFT, FeNO, chest x-ray, nasopharyngoscopy, sputum analysis, allergen test, omix blood sample, urine, sputum

Secondary Outcome Measures