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

Hanlim Pharm

Status and phase: Completed; Phase 3

Conditions: Acute Bronchitis

Treatments: Drug: Umkamin(Active Comparator); Drug: HL301(Experimental)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03654196

HL_HL301_301

Details and patient eligibility

About

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

Enrollment: 246 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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246 participants in 2 patient groups

HL301(Experimental)

Experimental group

Description:

Total 7 days of treatment and The daily dose is as follows \[Morning: HL301 1Tab + Placebo of Umkamin 1Tab\] \[Noon: Placebo of Umkamin 1Tab\] \[Evening: HL301 1Tab + Placebo of Umkamin 1Tab\]

Treatment:

Drug: HL301(Experimental)

Umkamin(Active Comparator)

Active Comparator group

Description:

Total 7 days of treatment and The daily dose is as follows \[Morning: Placebo of HL301 1Tab + Umkamin 1Tab\] \[Noon: Umkamin 1Tab\] \[Evening: Placebo of HL301 1Tab + Umkamin 1Tab\]

Treatment:

Drug: Umkamin(Active Comparator)