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

NCT03623282 | Completed Phase 4

• 1 other identifier: AG-SYN-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bronchitis, COPD

Keywords

Synatura; Chronic Obstructive Pulmonary Disease; Ahn Gook Pharmaceuticals

Outcome Measures

Primary Outcomes (1)

• COPD assessment test (CAT)

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

  Baseline, At 12weeks

Secondary Outcomes (3)

• Efficacy of pulmonary function in bronchitis type COPD patients

  Baseline, At 12weeks

• Efficacy of inflammation throughout the body in bronchitis type COPD patients

  Baseline, At 12weeks

• Total number of Bronchitis Severity Score (BSS)

  Baseline, At 12weeks

Study Arms (1)

Synatura® 15 mL

EXPERIMENTAL

Synatura syrup single arm

Drug: Synatura® 15 mL

Interventions

Synatura® 15 mL DRUG

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

Also known as: AG NPP709

Synatura® 15 mL

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post bronchodilator FEV1/FVC \< 0.7
• Smoking history of ≥10 packs per year
• to \<75 years of age
• Patients with symptoms of chronic bronchitis (in case they have symptoms of cough or sputum over 3 months)

You may not qualify if:

• Patients with acute exacerbation
• Patients with pneumonia
• Patients with active tuberculosis
• Pregnant women
• Breast-feeding women
• Patients with fructose intolerance

Sponsors & Collaborators

• Ahn-Gook Pharmaceuticals Co.,Ltd: lead

Study Sites (1)

Seoul St. Mary's hospital

Soeul, South Korea

Location

MeSH Terms

Conditions

Bronchitis; Pulmonary Disease, Chronic Obstructive

Interventions

AG NPP709

Condition Hierarchy (Ancestors)

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

Study Officials

• Chinkook Rhee, MD

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 9, 2018
• Study Start: April 17, 2017
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2018
• Last Updated: August 10, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)