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

Sponsor
Hanlim Pharm. Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03654196
Collaborator
(none)
246
Enrollment
1
Location
2
Arms
6.2
Actual Duration (Months)
39.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
246 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 16, 2018
Actual Primary Completion Date :
Sep 21, 2018
Actual Study Completion Date :
Sep 21, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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]

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]
Other Names:
  • HL301 and Placebo of Umkamin

    		•
    Active Comparator: 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]

    Drug: 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]
    Other Names:
  • Placebo of HL301 and Umkamin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bronchitis Severity Total Score(BSS) Change [Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)]

      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

    Secondary Outcome Measures

    1. The improvement and improvement rate of the tester for the treatment [Visit 3 (7 day)]

      Improvement and improvement rate are assessed by tester according to a 5 factors: Deterioration, No change, Slight to moderate improvement, Major improvement, Complete recovery

    2. The satisfaction of the subject (Questionnaire) [Visit 3 (7 day)]

      Satisfaction of the subject (Questionnaire) are assessed by subject according to a 5 factors: Very dissatisfied, Dissatisfied, Neutral, Satisfied, Very satisfied

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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:
    NCT03654196
    Other Study ID Numbers:
    • HL_HL301_301
    First Posted:
    Aug 31, 2018
    Last Update Posted:
    Feb 12, 2019
    Last Verified:
    Feb 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hanlim Pharm. Co., Ltd.
    Acute Bronchitis
    Additional relevant MeSH terms:
    Bronchitis
    Acute Disease

    Study Results

    No Results Posted as of Feb 12, 2019