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

October 10, 2017 updated by: Hanlim Pharm. Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Dongdaemun-gu
      • Seoul, Dongdaemun-gu, Korea, Republic of, 130-872
        • Kyung Hee University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The improvement and improvement rate of the tester for the treatment response (Chi-square test or Fisher's Exact test)
Time Frame: Visit 3 (7 day)
Evaluation period: Visit 3 (7 day)
Visit 3 (7 day)
The satisfaction of the subject (Questionnaire)
Time Frame: Visit 3 (7 day)
Evaluation period: Visit 3 (7 day)
Visit 3 (7 day)
Total usage of Acetaminophen
Time Frame: Visit 3 (7 day)
Evaluation period: Visit 3 (7 day)
Visit 3 (7 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanlim Pharm. Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2017

Primary Completion (Actual)

August 17, 2017

Study Completion (Actual)

August 28, 2017

Study Registration Dates

First Submitted

September 8, 2017

First Submitted That Met QC Criteria

October 10, 2017

First Posted (Actual)

October 16, 2017

Study Record Updates

Last Update Posted (Actual)

October 16, 2017

Last Update Submitted That Met QC Criteria

October 10, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL_HL301_202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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