None listed
Conditions
Interventions
Drug : A arm : ICS+LABA
B arm : ICS+LABA+LAMA
1 year observation, if acute exacerbation occur, patient drop out
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)ACOS definition - any of following 3 criteria (1) positive response bronchodilator: > 200mL forced expiratory volume in 1s (FEV1) and > 12% baseline (2) positive methacholine or mannitol provocation test (3) increase in FEV1 by > 12% and 200 mL from baseline after 4weeks of treatment and satisfied pre-bronchodilator FEV1/FVC ratio < 0.7 at the initial time and continuing after at least 3 months follow-up 2) controlled patients with ICS+LABA treatment 3) patients over 19 years of age 4) 30 = FEV1 (%) < 80 5) acute exacerbation history past 1-year 6) patients agreed to participate in clinical trials
Exclusion criteria
Exclusion criteria: 1) severe benign prostste hypertrophy (BPH) glaucoma End-stage renal disease, chronic renal failure 2) heart failure or previous history of myocardial infarction during 1-year 3) active infection such as pneumonia, pulmonary tuberculosis, fungal infection 4) moderate to severe bronchiectasis 5) Tb destroyed lung 6) acute exacervation of Visit 1 7) pregnancy and breast-feeding 8) using the systemic steroid due to other disease 9) receipt of immunotherapy 10) other patients judged to be inappropriate by clinician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first exacerbation | — |
Secondary
| Measure | Time frame |
|---|---|
| the change of pulmonary function test ;the change of Asthma Control Test (ACT) score;the change of inflammatory cells in sputum ;blood test ;Exhaled Breathing condensate (EBC);K-AQLQ (Asthma Quality of Life Questionnaire);the frequency of using rescue medication ;adverse reaction | — |
Countries
Korea, Republic of
Contacts
Public ContactSo-Young Park
Asan Medical Center
Outcome results
None listed