Bronchitis, COPD
Conditions
Keywords
Synatura, Chronic Obstructive Pulmonary Disease, Ahn Gook Pharmaceuticals
Brief summary
This study aims to examine the clinical efficacy of synatura in patients with chronic bronchitis type COPD in Korea.
Detailed description
Synatura® is a drug commonly used to suppress cough and sputum in patients with acute upper respiratory tract infection and chronic inflammatory bronchitis. According to the Phase III studies conducted in Korea, the safety and efficacy of Synatura® on antitussive and expectorant effects were confirmed in patients with acute upper respiratory infection and chronic inflammatory bronchitis. However, no studies have been conducted for the effects of Synatura® in patients with COPD. COPD is divided into emphysema type and chronic bronchitis type, while typical clinical symptoms of chronic bronchitis are cough and sputum. Therefore, Synatura®, which is effective for chronic bronchitis, is expected to be effective in patients with chronic bronchitis accompanied by COPD.
Interventions
DRUGSynatura® 15 mL
All subjects will receive Synatura® 15 mL every day three times for 3 months.
Sponsors
Ahn-Gook Pharmaceuticals Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Experimental(Single arm): The enrolled patients will be prescribed Synatura® following measurement of pre-dose pulmonary functions, quality of life and systemic inflammatory state. Pulmonary functions, quality of life and systemic inflammatory state will be repeatedly measured after taking Synatura® for 3 months, and the changes from pre-dose measurements will be observed.
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Post bronchodilator FEV1/FVC \< 0.7 2. Smoking history of ≥10 packs per year 3. 40 to \<75 years of age 4. Patients with symptoms of chronic bronchitis (in case they have symptoms of cough or sputum over 3 months)
Exclusion criteria
1. Patients with acute exacerbation 2. Patients with pneumonia 3. Patients with active tuberculosis 4. Pregnant women 5. Breast-feeding women 6. Patients with fructose intolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COPD assessment test (CAT) | Baseline, At 12weeks | Change from Baseline in baseline to 12 weeks for COPD assessment test (CAT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of pulmonary function in bronchitis type COPD patients | Baseline, At 12weeks | Pulmonary function test will be performed before and 3 months after taking Synatura. Assessment Tools: FVC (L), FVC (%), FEV1 (L), FEV1 (%), FEV1/FVC (%), TLC (%), RV (%), RV/TLC (%), DLCO (%), DLCO/VA (%) |
| Efficacy of inflammation throughout the body in bronchitis type COPD patients | Baseline, At 12weeks | Blood samples will be taken before and 3 months after taking Synatura, then stored and measured by ELISA in the laboratory. Assessment Tools: CRP, Fibrinogen, IL-6, TNF-α |
| Total number of Bronchitis Severity Score (BSS) | Baseline, At 12weeks | Bronchitis Severity Score (BSS) will be performed before and 3 months after taking Synatura The BSS measured cough, sputum, rales/ rhonchi, chest pain during coughing, and dyspnoea. Each of these features of acute bronchitis was scored by a welltrained doctor using a 5point Likert rating scale ranging from 0 to 4 (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe) The overall BSS will be graded as mild (0-7), moderate (8-14), and severe (15,20). |
Countries
South Korea
Outcome results
None listed