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

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ClinicalTrials.gov Identifier: NCT03309800
Recruitment Status : Completed
First Posted : October 16, 2017
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.

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 Type : Interventional  (Clinical Trial)
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 : March 29, 2017
Actual Primary Completion Date : August 17, 2017
Actual Study Completion Date : August 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acute Bronchitis

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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. The satisfaction of the subject (Questionnaire) [ Time Frame: Visit 3 (7 day) ]
    Evaluation period: Visit 3 (7 day)

  3. Total usage of Acetaminophen [ Time Frame: Visit 3 (7 day) ]
    Evaluation period: Visit 3 (7 day)



Information from the National Library of Medicine

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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): NCT03309800


Locations
Korea, Republic of
Kyung Hee University Hospital
Seoul, Dongdaemun-gu, Korea, Republic of, 130-872
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.

Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT03309800     History of Changes
Other Study ID Numbers: HL_HL301_202
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017

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