We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01420445
Recruitment Status : Completed
First Posted : August 19, 2011
Last Update Posted : September 26, 2013
Sponsor:
Information provided by (Responsible Party):

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
Acute Bronchitis Chronic Bronchitis 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  (Clinical Trial)
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 : September 2011
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Undecided
Experimental: YHD001 dose level 2
YHD001 dose level 2
Drug: YHD001 dose level 2
three times daily / 7 days
Other Name: Undecided
Active Comparator: Pelargonium sidoides extract
Pelargonium sidoides extract (Syrup)
Drug: Pelargonium sidoides extract
6-9mL three times daily / 7 days
Other Name: 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 [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. 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.

  2. time to response [ Time Frame: 7 days ]
  3. compliance, defined by drug accountability [ Time Frame: 7 days ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01420445


Locations
Korea, Republic of
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
More Information

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01420445     History of Changes
Other Study ID Numbers: YHD001-202
First Posted: August 19, 2011    Key Record Dates
Last Update Posted: September 26, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive