Skip to main content
OpenTrials
Completed

NCT Number: NCT03309800

A 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Bronchitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kyung Hee University Hospital

Seoul, Dongdaemun-gu, 130-872, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HL301

Drug

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

HL301(Placebo)

Drug

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hanlim Pharm. Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 16, 2017
Registry last updated
Oct 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.