Comparative study on effectiveness of inhaler treatment for elderly patients with asthma-Chronic Obstructive Pulmonary Disease (COPD) overlap syndrome (ACOS)
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0002050
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to first exacerbation
- Secondary Outcome Measures
Name Time Method 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