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

Ahn-Gook Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Bronchitis, COPD

Treatments: Drug: Synatura® 15 mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT03623282

AG-SYN-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Synatura® 15 mL

Experimental group

Description:

Synatura syrup single arm

Treatment:

Drug: Synatura® 15 mL