Study Regarding the Clinical Efficacy of Synatura® in Patients With Chronic Bronchitis Type COPD

Study Overview
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Brief Summary
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This study aims to examine the clinical efficacy of synatura in patients with chronic bronchitis type COPD in Korea.

Detailed Description
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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.

Official Title
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Study Regarding the Clinical Efficacy of Synatura® in Patients With Chronic Bronchitis Type COPD

Conditions
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Bronchitis, COPD

Intervention / Treatment
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* Drug: Synatura® 15 mL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post bronchodilator FEV1/FVC < 0.7 Smoking history of ≥10 packs per year 40 to <75 years of age Patients with symptoms of chronic bronchitis (in case they have symptoms of cough or sputum over 3 months) Exclusion Criteria: Patients with acute exacerbation Patients with pneumonia Patients with active tuberculosis Pregnant women Breast-feeding women Patients with fructose intolerance

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synatura® 15 mL<br>Synatura syrup single arm | Drug: Synatura® 15 mL<br>* All subjects will receive Synatura® 15 mL every day three times for 3 months.<br>* Other names: AG NPP709;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD assessment test (CAT) | Change from Baseline in baseline to 12 weeks for COPD assessment test (CAT) | Baseline, At 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of pulmonary function in bronchitis type COPD patients | 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 (%) | Baseline, At 12weeks | 
| Efficacy of inflammation throughout the body in bronchitis type COPD patients | 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 | Baseline, At 12weeks | 
| Total number of Bronchitis Severity Score (BSS) | 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). | Baseline, At 12weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Synatura, Chronic Obstructive Pulmonary Disease, Ahn Gook Pharmaceuticals