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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) (HL301)

Primary Purpose

Acute Bronchitis, Acute Exacerbations of Chronic Bronchitis

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HL301 300mg capsule
Placebo
Sponsored by
Hanlim Pharm. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bronchitis focused on measuring acute bronchitis, acute exacerbations of chronic bronchitis

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients who were increased the bleeding tendency
  2. Patients with any of Alanine aminotransferase, Aspartate aminotransferase or serum Blood Urea Nitrogen, Creatinine> 2 times of the normal upper range
  3. Patients who investigators determines to severe respiratory disease that would interfere with study assessment
  4. Patients with COPD(Chronic Obstructive Pulmonary Disease) history of stage 3 or more
  5. Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to study participation
  6. 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
  7. Patients who were treated with oral Antitussive, Mucolytic Agents,systemic antimicrobial agent within 3 days prior to study medication dosing
  8. Patients with drug or alcohol abuse
  9. 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)
  10. The aged person with severe medical history which is mental disorder(dementia), cancer, chronic renal failure, chronic liver failure
  11. Pregnant or breast-feeding
  12. Patients currently participating in or has participated in other clinical study within 30 days prior to study participation
  13. Patients who investigators determines not appropriate to take part in this clinical study

Sites / Locations

  • Kyung Hee University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

experimental A (0.6g/day)

experimental B (1.2g/day)

experimental C (1.8g/day)

Placebo

Arm Description

HL301 0.6g/day: 2 capsules at once, 3 times a day, for 7 days

HL301 1.2g/day: 2 capsules at once, 3 times a day, for 7 days

HL301 1.8g/day: 2 capsules at once, 3 times a day, for 7 days

placebo: 2 capsules at once, 3 times a day, for 7 days

Outcomes

Primary Outcome Measures

Bronchitis Severity Score
Bronchitis Severity Score

Secondary Outcome Measures

Breathlessness, Cough, and Sputum Scale
Breathlessness, Cough, and Sputum Scale
evaluation of symptoms of cough and sputum
Total usage of acetaminophen

Full Information

First Posted
September 2, 2014
Last Updated
September 25, 2014
Sponsor
Hanlim Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02250027
Brief Title
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)
Acronym
HL301
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanlim Pharm. Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the optimal dose of HL301 in patients with acute bronchitis or acute exacerbations of chronic bronchitis. - BSS(Bronchitis Severity Score), BCSS(Breathlessness, Cough, and Sputum Scale), evaluation of symptoms of cough and sputum

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bronchitis, Acute Exacerbations of Chronic Bronchitis
Keywords
acute bronchitis, acute exacerbations of chronic bronchitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental A (0.6g/day)
Arm Type
Experimental
Arm Description
HL301 0.6g/day: 2 capsules at once, 3 times a day, for 7 days
Arm Title
experimental B (1.2g/day)
Arm Type
Experimental
Arm Description
HL301 1.2g/day: 2 capsules at once, 3 times a day, for 7 days
Arm Title
experimental C (1.8g/day)
Arm Type
Experimental
Arm Description
HL301 1.8g/day: 2 capsules at once, 3 times a day, for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo: 2 capsules at once, 3 times a day, for 7 days
Intervention Type
Drug
Intervention Name(s)
HL301 300mg capsule
Other Intervention Name(s)
experimental A (0.6g/day) : HL301 300mg 2 capsule, experimental B (1.2g/day) : HL301 300mg 4 capsule, experimental C (1.8g/day) : HL301 300mg 6 capsule
Intervention Description
2 capsules at once, 3 times a day, for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Microcrystalline Cellulose
Intervention Description
2 capsules at once, 3 times a day, for 7 days
Primary Outcome Measure Information:
Title
Bronchitis Severity Score
Description
Bronchitis Severity Score
Time Frame
baseline(day 0) and day 7
Secondary Outcome Measure Information:
Title
Breathlessness, Cough, and Sputum Scale
Description
Breathlessness, Cough, and Sputum Scale
Time Frame
baseline(day 0) and day 7
Title
evaluation of symptoms of cough and sputum
Time Frame
baseline(day 0) and day 7
Title
Total usage of acetaminophen
Time Frame
baseline(day 0) and day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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)

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