Acute Bronchitis
Conditions
Keywords
Acute Bronchitis
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
Interventions
DRUGHL301(Experimental)
Total 7 days of treatment and The daily dose is as follows \[Morning: HL301 1Tab + Placebo of Umkamin 1Tab\] \[Noon: Placebo of Umkamin 1Tab\] \[Evening: HL301 1Tab + Placebo of Umkamin 1Tab\]
DRUGUmkamin(Active Comparator)
Total 7 days of treatment and The daily dose is as follows \[Morning: Placebo of HL301 1Tab + Umkamin 1Tab\] \[Noon: Umkamin 1Tab\] \[Evening: Placebo of HL301 1Tab + Umkamin 1Tab\]
Sponsors
Hanlim Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed