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

Primary Purpose

Bronchitis, COPD

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Synatura® 15 mL
Sponsored by
Ahn-Gook Pharmaceuticals Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchitis, COPD focused on measuring Synatura, Chronic Obstructive Pulmonary Disease, Ahn Gook Pharmaceuticals

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul St. Mary's hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Synatura® 15 mL

Arm Description

Synatura syrup single arm

Outcomes

Primary Outcome Measures

COPD assessment test (CAT)
Change from Baseline in baseline to 12 weeks for COPD assessment test (CAT)

Secondary Outcome Measures

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 (%)
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
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).

Full Information

First Posted
August 6, 2018
Last Updated
August 9, 2018
Sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03623282
Brief Title
Study Regarding the Clinical Efficacy of Synatura® in Patients With Chronic Bronchitis Type COPD
Official Title
Study Regarding the Clinical Efficacy of Synatura® in Patients With Chronic Bronchitis Type COPD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 17, 2017 (Actual)
Primary Completion Date
May 2, 2018 (Actual)
Study Completion Date
May 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchitis, COPD
Keywords
Synatura, Chronic Obstructive Pulmonary Disease, Ahn Gook Pharmaceuticals

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Synatura® 15 mL
Arm Type
Experimental
Arm Description
Synatura syrup single arm
Intervention Type
Drug
Intervention Name(s)
Synatura® 15 mL
Other Intervention Name(s)
AG NPP709
Intervention Description
All subjects will receive Synatura® 15 mL every day three times for 3 months.
Primary Outcome Measure Information:
Title
COPD assessment test (CAT)
Description
Change from Baseline in baseline to 12 weeks for COPD assessment test (CAT)
Time Frame
Baseline, At 12weeks
Secondary Outcome Measure Information:
Title
Efficacy of pulmonary function in bronchitis type COPD patients
Description
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 (%)
Time Frame
Baseline, At 12weeks
Title
Efficacy of inflammation throughout the body in bronchitis type COPD patients
Description
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
Time Frame
Baseline, At 12weeks
Title
Total number of Bronchitis Severity Score (BSS)
Description
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).
Time Frame
Baseline, At 12weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Post bronchodilator FEV1/FVC < 0.7 Smoking history of ≥10 packs per year 40 to <75 years of age Patients with symptoms of chronic bronchitis (in case they have symptoms of cough or sputum over 3 months) Exclusion Criteria: Patients with acute exacerbation Patients with pneumonia Patients with active tuberculosis Pregnant women Breast-feeding women Patients with fructose intolerance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chinkook Rhee, MD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's hospital
City
Soeul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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