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

Overview

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

Full Title of Study: “Study Regarding the Clinical Efficacy of Synatura® in Patients With Chronic Bronchitis Type COPD”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2, 2018

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

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

Arms, Groups and Cohorts

  • Experimental: Synatura® 15 mL
    • Synatura syrup single arm

Clinical Trial Outcome Measures

Primary Measures

  • COPD assessment test (CAT)
    • Time Frame: Baseline, At 12weeks
    • Change from Baseline in baseline to 12 weeks for COPD assessment test (CAT)

Secondary Measures

  • Efficacy of pulmonary function in bronchitis type COPD patients
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ahn-Gook Pharmaceuticals Co.,Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chinkook Rhee, MD, Principal Investigator, Seoul St. Mary’s Hospital

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