Acute Bronchitis
Conditions
Keywords
Acute Bronchitis
Brief summary
A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Placebo in acute bronchitis patients. Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject, Total usage of Acetaminophen
Interventions
DRUGHL301
HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment
DRUGHL301(Placebo)
HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment
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) | Evaluation period: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The improvement and improvement rate of the tester for the treatment response (Chi-square test or Fisher's Exact test) | Visit 3 (7 day) | Evaluation period: Visit 3 (7 day) |
| The satisfaction of the subject (Questionnaire) | Visit 3 (7 day) | Evaluation period: Visit 3 (7 day) |
| Total usage of Acetaminophen | Visit 3 (7 day) | Evaluation period: Visit 3 (7 day) |
Countries
South Korea
Outcome results
None listed