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

Sponsor
Yuhan Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01420445
Collaborator
(none)
118
Enrollment
1
Location
4
Arms
8
Duration (Months)
14.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: YHD001 dose level 1
  • Drug: YHD001 dose level 2
  • Drug: Pelargonium sidoides extract
  • Drug: placebo
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
118 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: YHD001 dose level 1

YHD001 dose level 1

Drug: YHD001 dose level 1
three times daily / 7 days
Other Names:
  • Undecided

    		•
    Experimental: YHD001 dose level 2

    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

    Outcome Measures

    Primary Outcome Measures

    1. Change of total symptom score from baseline to the end of treatment [7 days]

    Secondary Outcome Measures

    1. safety assessment [7 days]

      comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D7.

    2. time to response [7 days]

    3. compliance, defined by drug accountability [7 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Catholic University of Korea Seoul St. Mary'S Hospital Seoul Korea, Republic of 137-701

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuhan Corporation
    ClinicalTrials.gov Identifier:
    NCT01420445
    Other Study ID Numbers:
    • YHD001-202
    First Posted:
    Aug 19, 2011
    Last Update Posted:
    Sep 26, 2013
    Last Verified:
    Sep 1, 2013
    Additional relevant MeSH terms:
    Bronchitis
    Bronchitis, Chronic
    Acute Disease

    Study Results

    No Results Posted as of Sep 26, 2013