None listed
Conditions
Interventions
None listed
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult asthma patients between the ages of 18 and 80 years old 2) Definition of patients with mild asthma (GINA steps 1 to 2) Absolute Criteria: Blood eosinophil less than 300 & allergen check (skin tests 14 or more or MAST tests) All negative FENO (less than 25) or sputum eosinophil (less than 3%) in patients who meet the above absolute criteria. Register if one is satisfied - The above criteria are applied the same when reassessing the washout visibility after 6 months. 3) For more than three months, use low dose ICS only, LRTA only, or prn Ventolin without worsening asthma. The T2 low criteria above are tested after a month of drug interruption in a stable patient. a satisfied patient 4) New asthma-diagnosed mild case 5) FEV1 (%) > 80
Exclusion criteria
Exclusion criteria: 1) Minors under the age of 18 and older than 80 years of age; 2) Smoking power of 10PY or higher or current smokers 3) In case of acute deterioration of steroid injection above 30 mg prednisolone was required within 6 months prior to registration of the study; 4) In addition to severe asthma, severe respiratory diseases are accompanied by clinically significant respiratory diseases 5) In case it is difficult to evaluate asthma alone due to severe respiratory diseases (Lung canner, Tb destroyed Lung, Interstitial Lung disease, etc.) 6) Hypereosinophilic syndrome, ABPA, EGPA, COPD 7) Pregnant women 8) Patients who are unable to use LAMA drugs due to side effects £ Benign prostatic hypertrophy (BPH) in severe cases £ Glaucoma £ New disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variable in Detailed Task 1 is the response difference determined by the hierarchical critteria. In phase I clinical trials, each patient experiences both ICS and LAMA treatments according to cross-over design, and then measures which treatment they responded to better. Conduct a hypothesis test for non-equivalence. Since the null hypothesis is tested and the non-equivalence test is a one-sided test, the significance level of 0.025 is used to ensure the same rigor as a typical two-sided test. The secondary result variables are analyzed using the generalized linear mixed model using the link function according to the variable type. Use drugs and baseline charateristics as fixed effects and random effects for each patient's organ. | — |
Secondary
| Measure | Time frame |
|---|---|
| Continuous variables (such as asthma control score, symptom control survey, lung function, etc.) are analyzed using mixed effects linear regression method to satisfy normality if necessary, and count variables such as asthma deterioration frequency and frequency of use are analyzed. | — |
Countries
Korea, Republic of
Contacts
Public ContactLIM JIN
Asan Medical Center
Outcome results
None listed