Trial record 5 of 180 for:    Bronchitis, Chronic

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01420445
First received: July 20, 2011
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Acute Bronchitis
Chronic Bronchitis
Drug: YHD001 dose level 1
Drug: YHD001 dose level 2
Drug: Pelargonium sidoides extract
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • Change of total symptom score from baseline to the end of treatment [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety assessment [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D7.

  • time to response [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • compliance, defined by drug accountability [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 118
Study Start Date: September 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01420445     History of Changes
Other Study ID Numbers: YHD001-202
Study First Received: July 20, 2011
Last Updated: September 25, 2013
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 31, 2014