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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-17

Study Completion Date

2018-05-02

Brief Summary

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

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Detailed Description

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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.

Conditions

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Bronchitis, COPD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Experimental(Single arm):

The enrolled patients will be prescribed Synatura® following measurement of pre-dose pulmonary functions, quality of life and systemic inflammatory state. Pulmonary functions, quality of life and systemic inflammatory state will be repeatedly measured after taking Synatura® for 3 months, and the changes from pre-dose measurements will be observed.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Synatura® 15 mL

Synatura syrup single arm

Group Type EXPERIMENTAL

Synatura® 15 mL

Intervention Type DRUG

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

Interventions

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Synatura® 15 mL

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

Intervention Type DRUG

Other Intervention Names

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AG NPP709

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No