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

Acute Bronchitis Clinical Trial

Official title:

A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Umkamin Tab. in Acute Bronchitis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03654196
• Other study ID #: HL_HL301_301
• Status: Completed
• Phase: Phase 3
• Start date: March 16, 2018
• Est. completion date: September 21, 2018

Study information

• Verified date: February 2019
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Umkamin tab. in acute bronchitis patients

Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: September 21, 2018
• Est. primary completion date: September 21, 2018
• 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(Experimental)
Total 7 days of treatment and The daily dose is as follows [Morning: HL301 1Tab + Placebo of Umkamin 1Tab] [Noon: Placebo of Umkamin 1Tab] [Evening: HL301 1Tab + Placebo of Umkamin 1Tab]
• Umkamin(Active Comparator)
Total 7 days of treatment and The daily dose is as follows [Morning: Placebo of HL301 1Tab + Umkamin 1Tab] [Noon: Umkamin 1Tab] [Evening: Placebo of HL301 1Tab + Umkamin 1Tab]

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	The BSS comprises the following five symptoms typical for Acute Bronchitis: cough, sputum, rales on auscultation, chest pain on coughing, and dyspnoea. These symptoms are each assessed according to a 5-point Likert scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe	Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)
Secondary	The improvement and improvement rate of the tester for the treatment	Improvement and improvement rate are assessed by tester according to a 5 factors: Deterioration, No change, Slight to moderate improvement, Major improvement, Complete recovery	Visit 3 (7 day)
Secondary	The satisfaction of the subject (Questionnaire)	Satisfaction of the subject (Questionnaire) are assessed by subject according to a 5 factors: Very dissatisfied, Dissatisfied, Neutral, Satisfied, Very satisfied	Visit 3 (7 day)