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

Ahn-Gook Pharmaceuticals Co.,Ltd30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bronchitis, COPD

Interventions

Synatura® 15 mLDRUG

All subjects will receive Synatura® 15 mL every day three times for 3 months.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul St. Mary's hospital

Soeul, South Korea

Outcomes

Primary Outcomes

COPD assessment test (CAT)

Change from Baseline in baseline to 12 weeks for COPD assessment test (CAT)

Time frame: Baseline, At 12weeks

Secondary Outcomes

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 (%)

Time frame: 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

Time frame: 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).

Time frame: Baseline, At 12weeks

Data from ClinicalTrials.gov

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