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

Sponsor

Hanlim Pharm. Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03309800

Collaborator

(none)

168

Enrollment

Location

Arms

Actual Duration (Months)

33.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Bronchitis	Drug: HL301 Drug: HL301(Placebo)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 29, 2017

Actual Primary Completion Date :

Aug 17, 2017

Actual Study Completion Date :

Aug 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment	Drug: HL301 HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment
Placebo Comparator: Placebo comparator HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment	Drug: HL301(Placebo) HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment

Arm

Intervention/Treatment

Experimental: Experimental

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

Drug: HL301

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

Placebo Comparator: Placebo comparator

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

Drug: HL301(Placebo)

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

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyung Hee University Hospital	Seoul	Dongdaemun-gu	Korea, Republic of	130-872

Sponsors and Collaborators

Hanlim Pharm. Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanlim Pharm. Co., Ltd.

ClinicalTrials.gov Identifier:

NCT03309800

Other Study ID Numbers:

HL_HL301_202

First Posted:

Oct 16, 2017

Last Update Posted:

Oct 16, 2017

Last Verified:

Oct 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hanlim Pharm. Co., Ltd.

Acute Bronchitis

Additional relevant MeSH terms:

Bronchitis

Acute Disease

Study Results

No Results Posted as of Oct 16, 2017