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

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ClinicalTrials.gov Identifier: NCT03654196
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.

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
Acute Bronchitis Drug: HL301(Experimental) Drug: Umkamin(Active Comparator) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 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 : March 16, 2018
Estimated Primary Completion Date : September 21, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acute Bronchitis

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 Name: 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 Name: Placebo of HL301 and Umkamin




Primary Outcome Measures :
  1. Bronchitis Severity Total Score(BSS) Change [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654196


Contacts
Contact: Hee Sik Yun, CRC (822)9582817 yhs812498@naver.com
Contact: Na Hyun Kang, PM (822)34896298 nahyun.kang@hanlim.com

Locations
Korea, Republic of
Kyung Hee University Hospital Recruiting
Seoul, Dongdaemun-gu, Korea, Republic of, 130-872
Contact: Hee Sik Yun, CRC       yhs812498@naver.com   
Principal Investigator: Myung Jae Park, PI         
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.

Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT03654196     History of Changes
Other Study ID Numbers: HL_HL301_301
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes