Status:
COMPLETED
Safety/Tolerability and Efficacy of YHD001 in Patients With Acute and Chronic Bronchitis
Lead Sponsor:
Yuhan Corporation
Conditions:
Acute Bronchitis
Chronic Bronchitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 trea...
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 ...
Eligibility Criteria
Inclusion
- Male and female patients aged ≥18 year
- Provision of written informed consent
- Acute bronchitis with a Bronchitis Severity Score(BSS)≥five points
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT01420445
Start Date
September 1 2011
End Date
May 1 2012
Last Update
September 26 2013
Active Locations (1)
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1
The Catholic University of Korea Seoul St. Mary'S Hospital
Seoul, South Korea, 137-701