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

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

Study Overview

• Status: Completed
• Conditions: Bronchitis, COPD
• Intervention / Treatment: Drug: Synatura® 15 mL

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Soeul, Korea, Republic of
    • Seoul St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
• Investigators: Principal Investigator: Chinkook Rhee, MD, Seoul St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2017
• Primary Completion (Actual): May 2, 2018
• Study Completion (Actual): May 2, 2018

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Synatura; Ahn Gook Pharmaceuticals
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Acute Disease; Bronchitis; Bronchitis, Chronic
• Other Study ID Numbers: AG-SYN-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No