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A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo in Acute Bronchitis Patients

Primary Purpose

Acute Bronchitis

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HL301
HL301(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

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. (Bronchitis Severity Score)* ≥ 5point at Visit 2 (Randomized Visit)
  3. Acute bronchitis within 48hr based on Visit 2 (Randomized Visit)
  4. Those who can comply with the requirements of clinical trials
  5. Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

  1. Patients with respiratory and systemic infections requiring systemic antibiotic therapy
  2. Patients with bleeding tendency
  3. Patients who investigators determines to severe respiratory disease that would interfere with study assessment
  4. Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to Visit 2
  5. Patients who were treated with oral antihistamines, ACE suppressive. or systemic/inhalative glucocorticosteroid within 2 weeks prior to Visit 2

Sites / Locations

  • Kyung Hee University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Placebo comparator

Arm Description

HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment

HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment

Outcomes

Primary Outcome Measures

Bronchitis Severity Total Score(BSS) Change
Evaluation period: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)

Secondary Outcome Measures

The improvement and improvement rate of the tester for the treatment response (Chi-square test or Fisher's Exact test)
Evaluation period: Visit 3 (7 day)
The satisfaction of the subject (Questionnaire)
Evaluation period: Visit 3 (7 day)
Total usage of Acetaminophen
Evaluation period: Visit 3 (7 day)

Full Information

First Posted
September 8, 2017
Last Updated
October 10, 2017
Sponsor
Hanlim Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03309800
Brief Title
A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo in Acute Bronchitis Patients
Official Title
A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo in Acute Bronchitis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 29, 2017 (Actual)
Primary Completion Date
August 17, 2017 (Actual)
Study Completion Date
August 28, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Placebo in acute bronchitis patients. Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject, Total usage of Acetaminophen

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bronchitis
Keywords
Acute Bronchitis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment
Arm Title
Placebo comparator
Arm Type
Placebo Comparator
Arm Description
HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment
Intervention Type
Drug
Intervention Name(s)
HL301
Intervention Description
HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment
Intervention Type
Drug
Intervention Name(s)
HL301(Placebo)
Intervention Description
HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment
Primary Outcome Measure Information:
Title
Bronchitis Severity Total Score(BSS) Change
Description
Evaluation period: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)
Time Frame
Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)
Secondary Outcome Measure Information:
Title
The improvement and improvement rate of the tester for the treatment response (Chi-square test or Fisher's Exact test)
Description
Evaluation period: Visit 3 (7 day)
Time Frame
Visit 3 (7 day)
Title
The satisfaction of the subject (Questionnaire)
Description
Evaluation period: Visit 3 (7 day)
Time Frame
Visit 3 (7 day)
Title
Total usage of Acetaminophen
Description
Evaluation period: Visit 3 (7 day)
Time Frame
Visit 3 (7 day)

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 (Bronchitis Severity Score)* ≥ 5point at Visit 2 (Randomized Visit) Acute bronchitis within 48hr based on Visit 2 (Randomized Visit) Those who can comply with the requirements of clinical trials Written consent voluntarily to participate in this clinical trial Exclusion Criteria: Patients with respiratory and systemic infections requiring systemic antibiotic therapy Patients with bleeding tendency Patients who investigators determines to severe respiratory disease that would interfere with study assessment Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to Visit 2 Patients who were treated with oral antihistamines, ACE suppressive. or systemic/inhalative glucocorticosteroid within 2 weeks prior to Visit 2
Facility Information:
Facility Name
Kyung Hee University Hospital
City
Seoul
State/Province
Dongdaemun-gu
ZIP/Postal Code
130-872
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo in Acute Bronchitis Patients

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