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

Hanlim Pharm. Co., Ltd.1 site in 1 country168 target enrollmentMarch 29, 2017

ConditionsAcute Bronchitis

InterventionsHL301 HL301(Placebo)

DrugsHL301 HL301(Placebo)

Overview

Phase: Phase 2
Intervention: HL301
Conditions: Acute Bronchitis
Sponsor: Hanlim Pharm. Co., Ltd.
Enrollment: 168
Locations: 1
Primary Endpoint: Bronchitis Severity Total Score(BSS) Change
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 29, 2017

End Date

August 28, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hanlim Pharm. Co., Ltd.

Responsible Party

Sponsor

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

Experimental

HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment

Intervention: HL301

Placebo comparator

HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment

Intervention: HL301(Placebo)

Outcomes

Primary Outcomes

Bronchitis Severity Total Score(BSS) Change

Time Frame: 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 Outcomes

The improvement and improvement rate of the tester for the treatment response (Chi-square test or Fisher's Exact test)(Visit 3 (7 day))
The satisfaction of the subject (Questionnaire)(Visit 3 (7 day))
Total usage of Acetaminophen(Visit 3 (7 day))