A Multicenter, Randomized, Double-blind, Parallel Group S... | NCT02250027

Studies
A Multicenter, Randomized, Double-blind, Parallel Group Study to Determine the Optimal Dose of HL301 After 7 Days Oral Administration in Acute Bronchitis or Acute Exacerbations of Chronic Bronchitis Patients (HL301: Mixed Extract of Rehmannia Glutinosa, Schisandra and so on)

NCT02250027

Sponsor

Hanlim Pharm. Co., Ltd.

Status

Completed

Last Update Posted

Sep 26, 2014Estimated

Enrollment

156Actual

Phase

Phase 2

Conditions

Acute Bronchitis
Acute Exacerbations of Chronic Bronchitis

Interventions

HL301 300mg capsule
Placebo

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

Status Module

Record Verification Date

Sep 2014

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

Mar 2014

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Sep 2, 2014

First Submission Date that Met QC Criteria

Sep 25, 2014

First Posted Date

Sep 26, 2014Estimated

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

Sep 25, 2014

Last Update Posted Date

Sep 26, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

156Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental A (0.6g/day)	Experimental	HL301 0.6g/day: 2 capsules at once, 3 times a day, for 7 days	Drug: HL301 300mg capsule Drug: Placebo
experimental B (1.2g/day)	Experimental	HL301 1.2g/day: 2 capsules at once, 3 times a day, for 7 days	Drug: HL301 300mg capsule Drug: Placebo
experimental C (1.8g/day)	Experimental	HL301 1.8g/day: 2 capsules at once, 3 times a day, for 7 days	Drug: HL301 300mg capsule
Placebo	Placebo Comparator	placebo: 2 capsules at once, 3 times a day, for 7 days	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HL301 300mg capsule	Drug	2 capsules at once, 3 times a day, for 7 days	experimental A (0.6g/day) experimental B (1.2g/day) experimental C (1.8g/day)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bronchitis Severity Score	Bronchitis Severity Score	baseline(day 0) and day 7

Secondary Outcomes

Measure	Description	Time Frame
Breathlessness, Cough, and Sputum Scale	Breathlessness, Cough, and Sputum Scale	baseline(day 0) and day 7
evaluation of symptoms of cough and sputum		baseline(day 0) and day 7

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Both gender, 19 years ≤ age ≤ 80 years
Acute bronchitis or acute exacerbations of chronic bronchitis patients with BSS(Bronchitis Severity Score)* ≥ 5point at Visit1 and Visit2
Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

Patients who were increased the bleeding tendency
Patients with any of Alanine aminotransferase, Aspartate aminotransferase or serum Blood Urea Nitrogen, Creatinine> 2 times of the normal upper range
Patients who investigators determines to severe respiratory disease that would interfere with study assessment
Patients with COPD(Chronic Obstructive Pulmonary Disease) history of stage 3 or more
Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to study participation
Patients who were treated with oral β2-agonist, anticholinergic, Methylxanthine, antibiotics, antihistamines, sympathomimetic agent or oriental medicine/health functional food for antitussive and mucolytic Effect within 1 weeks prior to study participation
Patients who were treated with oral Antitussive, Mucolytic Agents,systemic antimicrobial agent within 3 days prior to study medication dosing
Patients with drug or alcohol abuse
Patients with clinically significant active liver, renal, cardiovascular, respiratory, endocrine, central nervous system disease or history of malignant tumor or mental illness(except no relapse for 5 years after surgery)
The aged person with severe medical history which is mental disorder(dementia), cancer, chronic renal failure, chronic liver failure
Pregnant or breast-feeding
Patients currently participating in or has participated in other clinical study within 30 days prior to study participation
Patients who investigators determines not appropriate to take part in this clinical study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Aug 27, 2018
Reset	Feb 1, 2019
Release	Feb 12, 2019

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 27, 2018			Feb 1, 2019
Feb 12, 2019			May 10, 2019
May 17, 2019			Jul 19, 2019

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases