Back to resultsSafety/Tolerability and Efficacy of YHD001 in Patients With Acute and Chronic Bronchitis
Primary Purpose
Acute Bronchitis, Chronic Bronchitis
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YHD001 dose level 1
YHD001 dose level 2
Pelargonium sidoides extract
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Bronchitis
Eligibility 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
Sites / Locations
- The Catholic University of Korea Seoul St. Mary'S Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
YHD001 dose level 1
YHD001 dose level 2
Pelargonium sidoides extract
Placebo
Arm Description
YHD001 dose level 1
YHD001 dose level 2
Pelargonium sidoides extract (Syrup)
Placebo for YHD001 & active comparator(syrup)
Outcomes
Primary Outcome Measures
Change of total symptom score from baseline to the end of treatment
Secondary Outcome Measures
safety assessment
comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D7.
time to response
compliance, defined by drug accountability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01420445
Brief Title
Safety/Tolerability and Efficacy of YHD001 in Patients With Acute and Chronic Bronchitis
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 Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bronchitis, Chronic Bronchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
YHD001 dose level 1
Arm Type
Experimental
Arm Description
YHD001 dose level 1
Arm Title
YHD001 dose level 2
Arm Type
Experimental
Arm Description
YHD001 dose level 2
Arm Title
Pelargonium sidoides extract
Arm Type
Active Comparator
Arm Description
Pelargonium sidoides extract (Syrup)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for YHD001 & active comparator(syrup)
Intervention Type
Drug
Intervention Name(s)
YHD001 dose level 1
Other Intervention Name(s)
Undecided
Intervention Description
three times daily / 7 days
Intervention Type
Drug
Intervention Name(s)
YHD001 dose level 2
Other Intervention Name(s)
Undecided
Intervention Description
three times daily / 7 days
Intervention Type
Drug
Intervention Name(s)
Pelargonium sidoides extract
Other Intervention Name(s)
UMCKAMIN Syrup
Intervention Description
6-9mL three times daily / 7 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
three times daily / 7 days
Primary Outcome Measure Information:
Title
Change of total symptom score from baseline to the end of treatment
Time Frame
7 days
Secondary Outcome Measure Information:
Title
safety assessment
Description
comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D7.
Time Frame
7 days
Title
time to response
Time Frame
7 days
Title
compliance, defined by drug accountability
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Kyoon Kim, M.D., Ph.D.
Organizational Affiliation
Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital,College of Medicine, The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Catholic University of Korea Seoul St. Mary'S Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Safety/Tolerability and Efficacy of YHD001 in Patients With Acute and Chronic Bronchitis
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