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

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

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

Study Overview

• Status: Completed
• Conditions: Acute Bronchitis
• Intervention / Treatment: Drug: HL301(Experimental); Drug: Umkamin(Active Comparator)

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dongdaemun-gu
    • Seoul, Dongdaemun-gu, Korea, Republic of, 130-872
      • Kyung Hee University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HL301(Experimental); 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]	Drug: HL301(Experimental); 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]; Other Names: HL301 and Placebo of Umkamin
Active Comparator: Umkamin(Active Comparator); 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]	Drug: Umkamin(Active Comparator); 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]; Other Names: Placebo of HL301 and Umkamin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Visit 3 (7 day)
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	Visit 3 (7 day)

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Actual): September 21, 2018
• Study Completion (Actual): September 21, 2018

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 10, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Acute Bronchitis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Acute Disease; Bronchitis
• Other Study ID Numbers: HL_HL301_301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No