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

Acute Bronchitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03309800
• Other study ID #: HL_HL301_202
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2017
• Last updated: October 10, 2017
• Start date: March 29, 2017
• Est. completion date: August 28, 2017

Study information

• Verified date: October 2017
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: August 28, 2017
• Est. primary completion date: August 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Bronchitis
• Acute Disease
• Bronchitis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital	Seoul	Dongdaemun-gu

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bronchitis Severity Total Score(BSS) Change	Evaluation period: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)	Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)
Secondary	The improvement and improvement rate of the tester for the treatment response (Chi-square test or Fisher's Exact test)	Evaluation period: Visit 3 (7 day)	Visit 3 (7 day)
Secondary	The satisfaction of the subject (Questionnaire)	Evaluation period: Visit 3 (7 day)	Visit 3 (7 day)
Secondary	Total usage of Acetaminophen	Evaluation period: Visit 3 (7 day)	Visit 3 (7 day)