Status:
COMPLETED
Safety and Efficacy of YHD001 in Asthma
Lead Sponsor:
Yuhan Corporation
Conditions:
Asthma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The main objective is to evaluate the safety/tolerability and efficacy of YHD001 compared to singulair or placebo in patients (n=96) with partially controlled asthma. The study will conduct with 4 co...
Detailed Description
Singulair: Montelukast sodium (leukotriene modulator)
Eligibility Criteria
Inclusion
- Provision of signed written informed consent
- Acceptable medical history, physical exam,laboratory tests and EKG, during screening
- Nonsmoking (for longer than 1 year) patients with asthma
- Reversible airways obstruction (an increase in FEV1 absolute value of 12% or greater) 20 to 30 minutes after inhalation of b-agonist
- FEV1 between 50% and 85% of the predicted value (withholding short-acting, inhaled b2-adrenergic agonist for 6 hours)
Exclusion
- History of any clinically significant disease
- History of drug/chemical/alcohol abuse
- Active upper respiratory tract infection within 3 weeks, emergency room treatment for asthma within 1 month, or hospitalization for asthma within 3 months of the prestudy visit
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01424124
Start Date
November 1 2011
End Date
January 1 2014
Last Update
July 10 2014
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea