Study Regarding the Clinical Efficacy of Synatura® in Pat... | NCT03623282

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

NCT03623282

Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Status

Completed

Last Update Posted

Aug 10, 2018Actual

Enrollment

30Actual

Phase

Phase 4

Conditions

Bronchitis, COPD

Interventions

Synatura® 15 mL

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 17, 2017Actual

Primary Completion Date

May 2, 2018Actual

Completion Date

May 2, 2018Actual

First Submitted Date

Aug 6, 2018

First Submission Date that Met QC Criteria

Aug 6, 2018

First Posted Date

Aug 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2018

Last Update Posted Date

Aug 10, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Synatura® 15 mL	Experimental	Synatura syrup single arm	Drug: Synatura® 15 mL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Synatura® 15 mL	Drug	All subjects will receive Synatura® 15 mL every day three times for 3 months.	Synatura® 15 mL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
COPD assessment test (CAT)	Change from Baseline in baseline to 12 weeks for COPD assessment test (CAT)	Baseline, At 12weeks

Secondary Outcomes

Measure	Description	Time Frame
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 (%)	Baseline, At 12weeks
Efficacy of inflammation throughout the body in bronchitis type COPD patients

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chinkook Rhee, MD	Seoul St. Mary's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul St. Mary's hospital		Soeul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 25, 2014	Jul 23, 2018	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D001991	Bronchitis
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000588959	AG NPP709

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

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.