Safety/Tolerability and Efficacy of YHD001 in Patients With Acute and Chronic Bronchitis

September 25, 2013 updated by: Yuhan Corporation

Randomized, Double-blind, Placebo/Active-controlled, Multi-center, Phase 3 Clinical Trial to Investigate the Safety/Tolerability and Efficacy of YHD001 After Oral Administration in Patients With Acute or Chronic Bronchitis

The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), pelargonium sidoides extract 9mL(t.i.d.) or Placebo for 7 days.

The treatments will be assigned randomly to patients (n=116) with acute or chronic bronchitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The outcome measures is to evaluate the overall change from baseline to the end of treatment in scores relating to the severity of four symptom of bronchitis: cough, sputum, QOL of daily life, QOL of falling asleep at night.

Study Type

Interventional

Enrollment (Actual)

118

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
      • Seoul, Korea, Republic of, 137-701
        • The Catholic University of Korea Seoul St. Mary'S 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients aged ≥18 year
  • Provision of written informed consent
  • Acute bronchitis with a Bronchitis Severity Score(BSS)≥five points

Exclusion Criteria:

  • History of any clinically significant disease
  • History of drug/chemical/alcohol abuse
  • Use of antibiotics, anti-histamine during the 7 days before administration of the investigational product

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: YHD001 dose level 1
Drug: YHD001 dose level 1
three times daily / 7 days
Other Names:
  • Undecided
EXPERIMENTAL: YHD001 dose level 2
Drug: YHD001 dose level 2
three times daily / 7 days
Other Names:
  • Undecided
ACTIVE_COMPARATOR: Pelargonium sidoides extract
Pelargonium sidoides extract (Syrup)
Drug: Pelargonium sidoides extract
6-9mL three times daily / 7 days
Other Names:
  • UMCKAMIN Syrup
PLACEBO_COMPARATOR: Placebo
Placebo for YHD001 & active comparator(syrup)
Drug: placebo
three times daily / 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of total symptom score from baseline to the end of treatment
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety assessment
Time Frame: 7 days
comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D7.
7 days
time to response
Time Frame: 7 days
7 days
compliance, defined by drug accountability
Time Frame: 7 days
7 days

Collaborators and Investigators

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

Sponsor

Yuhan Corporation

Investigators

  • Principal Investigator: Young Kyoon Kim, M.D., Ph.D., Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital,College of Medicine, The Catholic University of Korea

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

September 1, 2011

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

July 20, 2011

First Submitted That Met QC Criteria

August 18, 2011

First Posted (ESTIMATE)

August 19, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 26, 2013

Last Update Submitted That Met QC Criteria

September 25, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YHD001-202

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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