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

Phase 3

Completed

• Conditions: Acute Bronchitis
• Interventions: Drug: HL301(Experimental); Drug: Umkamin(Active Comparator)

• Registration Number: NCT03654196
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-16
• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Primary Completion: 2018-09-21
• Study Completion: 2018-09-21
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-10
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HL301(Experimental)	HL301(Experimental)	Total 7 days of treatment and The daily dose is as follows \[Morning: HL301 1Tab + Placebo of Umkamin 1Tab\] \[Noon: Placebo of Umkamin 1Tab\] \[Evening: HL301 1Tab + Placebo of Umkamin 1Tab\]
Umkamin(Active Comparator)	Umkamin(Active Comparator)	Total 7 days of treatment and The daily dose is as follows \[Morning: Placebo of HL301 1Tab + Umkamin 1Tab\] \[Noon: Umkamin 1Tab\] \[Evening: Placebo of HL301 1Tab + Umkamin 1Tab\]

Primary Outcome Measures

Name	Time	Method
Bronchitis Severity Total Score(BSS) Change	Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)	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

Name	Time	Method
The improvement and improvement rate of the tester for the treatment	Visit 3 (7 day)	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)	Visit 3 (7 day)	Satisfaction of the subject (Questionnaire) are assessed by subject according to a 5 factors: Very dissatisfied, Dissatisfied, Neutral, Satisfied, Very satisfied

Trial Locations

Locations (1)

Kyung Hee University Hospital; 🇰🇷 Seoul, Dongdaemun-gu, Korea, Republic of