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
Overview
- Phase
- Phase 3
- Intervention
- HL301(Experimental)
- Conditions
- Acute Bronchitis
- Sponsor
- Hanlim Pharm. Co., Ltd.
- Enrollment
- 246
- Locations
- 1
- Primary Endpoint
- Bronchitis Severity Total Score(BSS) Change
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
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
Arms & Interventions
HL301(Experimental)
Total 7 days of treatment and The daily dose is as follows \[Morning: HL301 1Tab + Placebo of Umkamin 1Tab\] \[Noon: Placebo of Umkamin 1Tab\] \[Evening: HL301 1Tab + Placebo of Umkamin 1Tab\]
Intervention: HL301(Experimental)
Umkamin(Active Comparator)
Total 7 days of treatment and The daily dose is as follows \[Morning: Placebo of HL301 1Tab + Umkamin 1Tab\] \[Noon: Umkamin 1Tab\] \[Evening: Placebo of HL301 1Tab + Umkamin 1Tab\]
Intervention: Umkamin(Active Comparator)
Outcomes
Primary Outcomes
Bronchitis Severity Total Score(BSS) Change
Time Frame: 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 Outcomes
- The improvement and improvement rate of the tester for the treatment(Visit 3 (7 day))
- The satisfaction of the subject (Questionnaire)(Visit 3 (7 day))