Patients with severe asthma are at risk of increased metabolic disease and severity, including drug-related side effects, and patients requiring systemic steroid therapy have reported higher mortality rates. Recent developments in asthma mechanism research have highlighted omalizumab, reslizumab, mepolizumab, benralizumab, and dupilumab as novel treatments that reduce acute exacerbations and decrease systemic steroid use and side effects in severe asthma.
Therefore, in this study, various genomic analyses will be performed on patients with severe asthma to attempt molecular phenotype analysis beyond current biomarkers, and a personalized precision medicine model will be established based on these analyses.

The study will target severe asthma patients registered at each institution for a period of 10-18 months per patient. Prior to registration, there will be a screening period of 1-3 months during which general phenotyping, such as blood tests and sputum tests, will be performed. Based on the evaluation results, patients will be divided into T2 high and T2 low groups, and if patients in the T2 high group meet the indications for biological agents, treatment with appropriate medication will be initiated at the discretion of the physician.

Subsequently, sample collection for multiomics analysis, survey evaluations, and CRF creation will be performed at 1 month, 6 months, 10-12 months after registration, and 6 months after the end of treatment or at the time of exacerbation. In the case of patients using biological agents, a mid-term evaluation will be conducted at 6 months after registration and a final evaluation at 10-12 months. In addition, patient follow-up will be conducted by sample collection, survey evaluations, and CRF creation at the time of the last visit after 6 months of the end of drug support. In cases where biological agents are not indicated, existing treatment will be continued, and sample collection will be performed at the same time points as the biological agent use group: at registration, 1 month, 6 months, and 10-12 months.

• Adult asthma patients between 18 and 79 years old
• Patients who meet the criteria for severe asthma according to the 2014 ATS/ERS guidelines (GINA 4/5) that are barely controlled or not well controlled with high-dose inhaled steroids and additional controller medications, or patients who require systemic steroid therapy for more than 50% of the year to control symptoms or those for whom asthma is not controlled despite the use of the above-mentioned drugs.
  • - Patients for whom asthma is not controlled with the above-mentioned drugs (if any of the following apply):
  • a. ACT score less than 20 points or GINA level 5.
  • b. Frequent exacerbations (more than 2 per year)
  • c. Evidence of airflow obstruction on pulmonary function testing
  • d. Chronic rhinosinusitis with nasal polyps.

• - If the participant is using biologic therapy: support for medication costs is available.
• - If the participant is not using biologic therapy: support for study participation fees and test costs, including pulmonary function tests, induced sputum, FeNO, blood tests, chest CT scans, etc., is available.

Patients with severe asthma are at risk of increased metabolic disease and severity, including drug-related side effects, and patients requiring systemic steroid therapy have reported higher mortality rates. Recent developments in asthma mechanism research have highlighted omalizumab, reslizumab, mepolizumab, benralizumab, and dupilumab as novel treatments that reduce acute exacerbations and decrease systemic steroid use and side effects in severe asthma.
Therefore, in this study, various genomic analyses will be performed on patients with severe asthma to attempt molecular phenotype analysis beyond current biomarkers, and a personalized precision medicine model will be established based on these analyses.

The study will target severe asthma patients registered at each institution for a period of 10-18 months per patient. Prior to registration, there will be a screening period of 1-3 months during which general phenotyping, such as blood tests and sputum tests, will be performed. Based on the evaluation results, patients will be divided into T2 high and T2 low groups, and if patients in the T2 high group meet the indications for biological agents, treatment with appropriate medication will be initiated at the discretion of the physician.

Subsequently, sample collection for multiomics analysis, survey evaluations, and CRF creation will be performed at 1 month, 6 months, 10-12 months after registration, and 6 months after the end of treatment or at the time of exacerbation. In the case of patients using biological agents, a mid-term evaluation will be conducted at 6 months after registration and a final evaluation at 10-12 months. In addition, patient follow-up will be conducted by sample collection, survey evaluations, and CRF creation at the time of the last visit after 6 months of the end of drug support. In cases where biological agents are not indicated, existing treatment will be continued, and sample collection will be performed at the same time points as the biological agent use group: at registration, 1 month, 6 months, and 10-12 months.

• Adult asthma patients between 18 and 79 years old
• Patients who meet the criteria for severe asthma according to the 2014 ATS/ERS guidelines (GINA 4/5) that are barely controlled or not well controlled with high-dose inhaled steroids and additional controller medications, or patients who require systemic steroid therapy for more than 50% of the year to control symptoms or those for whom asthma is not controlled despite the use of the above-mentioned drugs.
  • - Patients for whom asthma is not controlled with the above-mentioned drugs (if any of the following apply)
  • a. ACT score less than 20 points or GINA level 5.
  • b. Frequent exacerbations (more than 2 per year)
  • c. Evidence of airflow obstruction on pulmonary function testing
  • d. Chronic rhinosinusitis with nasal polyps.

• - If the participant is using biologic therapy: support for medication costs is available.
• - If the participant is not using biologic therapy: support for study participation fees and test costs, including pulmonary function tests, induced sputum, FeNO, blood tests, chest CT scans, etc., is available.