Status:
COMPLETED
Safety and Efficacy of WIN-901X in Asthma
Lead Sponsor:
Whanin Pharmaceutical Company
Conditions:
Asthma
Eligibility:
All Genders
20-79 years
Phase:
PHASE2
Brief Summary
This clinical trial is designed to evaluate the efficacy, dose-response and safety of WIN-901X in Asthma patients.
Detailed Description
Double blinded, Randomized, Placebo Controlled, Multi-center, Phase 2 : Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of WIN-901X in Asthma Patients
Eligibility Criteria
Inclusion
- Greater than or equal to 20 and less than 80 years of age
- Have physician diagnosed asthma with irreversible airway obstruction at least 6 months prior to the screening
- FEV1 between 60% and 85% before inhaling fast-acting bronchodilator at screening
- No history of smoking at least one year prior to the screening
- Having voluntarily signed an informed consent
Exclusion
- Have visited emergency room due to the worsening asthma symptoms, within 4 weeks before the screening
- Have been hospitalized due to an acute worsening of asthma within 3 months before the screening
- Have a history of laryngitis, pyrexia, sinusitis, otitis media, respiratory tract infection, and infectious rhinitis within 4 weeks prior to the screening
- Have malignant tumor
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT01820481
Start Date
September 1 2012
End Date
November 1 2013
Last Update
December 9 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ajou University Medical Center
Suwon, South Korea