A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo in Acute Bronchitis Patients

Phase 2

Completed

• Conditions: Acute Bronchitis
• Interventions: Drug: HL301(Placebo); Drug: HL301

• Registration Number: NCT03309800
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-29
• Primary Completion: 2017-08-17
• Study Completion: 2017-08-28
• Study First Submitted: 2017-09-08
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-10
• Last Update Submitted: 2017-10-10
• Study First Posted: 2017-10-16
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Kyung Hee University Hospital; 🇰🇷 Seoul, Dongdaemun-gu, Korea, Republic of