Status:
COMPLETED
A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo in Acute Bronchitis Patients
Lead Sponsor:
Hanlim Pharm. Co., Ltd.
Conditions:
Acute Bronchitis
Eligibility:
All Genders
19-80 years
Phase:
PHASE2
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: BS...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2017
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT03309800
Start Date
March 29 2017
End Date
August 28 2017
Last Update
October 16 2017
Active Locations (1)
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1
Kyung Hee University Hospital
Seoul, Dongdaemun-gu, South Korea, 130-872