Overview

Safety and Efficacy of WIN-901X in Asthma

Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
0
Participant gender:
All
Summary
This clinical trial is designed to evaluate the efficacy, dose-response and safety of WIN-901X in Asthma patients.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Whanin Pharmaceutical Company
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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