Back to resultsA Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Umkamin Tab in Acute Bronchitis Patients
Primary Purpose
Acute Bronchitis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HL301(Experimental)
Umkamin(Active Comparator)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Bronchitis focused on measuring Acute Bronchitis
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
Sites / Locations
- Kyung Hee University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HL301(Experimental)
Umkamin(Active Comparator)
Arm Description
Total 7 days of treatment and The daily dose is as follows [Morning: HL301 1Tab + Placebo of Umkamin 1Tab] [Noon: Placebo of Umkamin 1Tab] [Evening: HL301 1Tab + Placebo of Umkamin 1Tab]
Total 7 days of treatment and The daily dose is as follows [Morning: Placebo of HL301 1Tab + Umkamin 1Tab] [Noon: Umkamin 1Tab] [Evening: Placebo of HL301 1Tab + Umkamin 1Tab]
Outcomes
Primary Outcome Measures
Bronchitis Severity Total Score(BSS) Change
The BSS comprises the following five symptoms typical for Acute Bronchitis: cough, sputum, rales on auscultation, chest pain on coughing, and dyspnoea. These symptoms are each assessed according to a 5-point Likert scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe
Secondary Outcome Measures
The improvement and improvement rate of the tester for the treatment
Improvement and improvement rate are assessed by tester according to a 5 factors: Deterioration, No change, Slight to moderate improvement, Major improvement, Complete recovery
The satisfaction of the subject (Questionnaire)
Satisfaction of the subject (Questionnaire) are assessed by subject according to a 5 factors: Very dissatisfied, Dissatisfied, Neutral, Satisfied, Very satisfied
Full Information
NCT ID
NCT03654196
First Posted
August 29, 2018
Last Updated
February 10, 2019
Sponsor
Hanlim Pharm. Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03654196
Brief Title
A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Umkamin Tab in Acute Bronchitis Patients
Official Title
A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Umkamin Tab. in Acute Bronchitis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
September 21, 2018 (Actual)
Study Completion Date
September 21, 2018 (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, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Umkamin tab. in acute bronchitis patients
Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject
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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
246 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HL301(Experimental)
Arm Type
Experimental
Arm Description
Total 7 days of treatment and The daily dose is as follows [Morning: HL301 1Tab + Placebo of Umkamin 1Tab] [Noon: Placebo of Umkamin 1Tab] [Evening: HL301 1Tab + Placebo of Umkamin 1Tab]
Arm Title
Umkamin(Active Comparator)
Arm Type
Active Comparator
Arm Description
Total 7 days of treatment and The daily dose is as follows [Morning: Placebo of HL301 1Tab + Umkamin 1Tab] [Noon: Umkamin 1Tab] [Evening: Placebo of HL301 1Tab + Umkamin 1Tab]
Intervention Type
Drug
Intervention Name(s)
HL301(Experimental)
Other Intervention Name(s)
HL301 and Placebo of Umkamin
Intervention Description
Total 7 days of treatment and The daily dose is as follows [Morning: HL301 1Tab + Placebo of Umkamin 1Tab] [Noon: Placebo of Umkamin 1Tab] [Evening: HL301 1Tab + Placebo of Umkamin 1Tab]
Intervention Type
Drug
Intervention Name(s)
Umkamin(Active Comparator)
Other Intervention Name(s)
Placebo of HL301 and Umkamin
Intervention Description
Total 7 days of treatment and The daily dose is as follows [Morning: Placebo of HL301 1Tab + Umkamin 1Tab] [Noon: Umkamin 1Tab] [Evening: Placebo of HL301 1Tab + Umkamin 1Tab]
Primary Outcome Measure Information:
Title
Bronchitis Severity Total Score(BSS) Change
Description
The BSS comprises the following five symptoms typical for Acute Bronchitis: cough, sputum, rales on auscultation, chest pain on coughing, and dyspnoea. These symptoms are each assessed according to a 5-point Likert scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe
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
Description
Improvement and improvement rate are assessed by tester according to a 5 factors: Deterioration, No change, Slight to moderate improvement, Major improvement, Complete recovery
Time Frame
Visit 3 (7 day)
Title
The satisfaction of the subject (Questionnaire)
Description
Satisfaction of the subject (Questionnaire) are assessed by subject according to a 5 factors: Very dissatisfied, Dissatisfied, Neutral, Satisfied, Very satisfied
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 Umkamin Tab in Acute Bronchitis Patients
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