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Completed

NCT Number: NCT03623282

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

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

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Key information

Conditions

Bronchitis, COPD Bronchial Diseases Bronchitis Chronic Disease Disease Attributes Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul St. Mary's hospital

Soeul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synatura® 15 mL

Drug

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

Other names: AG NPP709

Primary outcomes

  1. COPD assessment test (CAT)

    Time frame: Baseline, At 12weeks

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

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 9, 2018
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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