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

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ClinicalTrials.gov Identifier: NCT03623282
Recruitment Status : Completed
First Posted : August 9, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Ahn-Gook Pharmaceuticals Co.,Ltd

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

Condition or disease Intervention/treatment Phase
Bronchitis, COPD Drug: Synatura® 15 mL Phase 4

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  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Study Regarding the Clinical Efficacy of Synatura® in Patients With Chronic Bronchitis Type COPD
Actual Study Start Date : April 17, 2017
Actual Primary Completion Date : May 2, 2018
Actual Study Completion Date : May 2, 2018

Resource links provided by the National Library of Medicine


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 Name: AG NPP709




Primary Outcome Measures :
  1. COPD assessment test (CAT) [ Time Frame: Baseline, At 12weeks ]
    Change from Baseline in baseline to 12 weeks for COPD assessment test (CAT)


Secondary Outcome Measures :
  1. Efficacy of pulmonary function in bronchitis type COPD patients [ Time Frame: Baseline, At 12weeks ]

    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 (%)


  2. Efficacy of inflammation throughout the body in bronchitis type COPD patients [ Time Frame: Baseline, At 12weeks ]

    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


  3. Total number of Bronchitis Severity Score (BSS) [ Time Frame: Baseline, At 12weeks ]

    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).




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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623282


Locations
Korea, Republic of
Seoul St. Mary's hospital
Soeul, Korea, Republic of
Sponsors and Collaborators
Ahn-Gook Pharmaceuticals Co.,Ltd
Investigators
Principal Investigator: Chinkook Rhee, MD Seoul St. Mary's Hospital
  Study Documents (Full-Text)

Documents provided by Ahn-Gook Pharmaceuticals Co.,Ltd:
Study Protocol  [PDF] November 25, 2014


Responsible Party: Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT03623282     History of Changes
Other Study ID Numbers: AG-SYN-01
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ahn-Gook Pharmaceuticals Co.,Ltd:
Synatura
Chronic Obstructive Pulmonary Disease
Ahn Gook Pharmaceuticals

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchitis, Chronic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive