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
|Condition or disease||Intervention/treatment||Phase|
|Bronchitis, COPD||Drug: Synatura® 15 mL||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
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)|
|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|
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
- COPD assessment test (CAT) [ Time Frame: Baseline, At 12weeks ]Change from Baseline in baseline to 12 weeks for COPD assessment test (CAT)
- 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 (%)
- 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
- 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).
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
|Korea, Republic of|
|Seoul St. Mary's hospital|
|Soeul, Korea, Republic of|
|Principal Investigator:||Chinkook Rhee, MD||Seoul St. Mary's Hospital|