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

Bronchitis, COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03623282
• Other study ID #: AG-SYN-01
• Status: Completed
• Phase: Phase 4
• Start date: April 17, 2017
• Est. completion date: May 2, 2018

Study information

• Verified date: August 2018
• Source: Ahn-Gook Pharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2, 2018
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Bronchitis
• Bronchitis, Chronic
• Bronchitis, COPD

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's hospital	Soeul

Sponsors (1)

Lead Sponsor	Collaborator
Ahn-Gook Pharmaceuticals Co.,Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COPD assessment test (CAT)	Change from Baseline in baseline to 12 weeks for COPD assessment test (CAT)	Baseline, At 12weeks
Secondary	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
Secondary	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-a	Baseline, At 12weeks
Secondary	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