Safety and Efficacy of WIN-901X in Asthma

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: WIN-901X dose level 1; Drug: WIN-901X dose level 2; Drug: WIN-901X dose level 3; Drug: Placebo

• Registration Number: NCT01820481
• Lead Sponsor: Whanin Pharmaceutical Company

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

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-03-25
• Study First Submitted QC: 2013-03-25
• Study First Posted: 2013-03-28
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-05
• Last Update Posted: 2013-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment 1	WIN-901X dose level 1	-
Treatment 2	WIN-901X dose level 2	-
Treatment 3	WIN-901X dose level 3	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Compare the change of FEV1% to the baseline after the medication	Baseline, week 12	FEV1: Forced Expiratory Volume In One Second

Secondary Outcome Measures

Name	Time	Method
Ratio of the date, where no rescue drug was used, during the trial	Baseline, week 12
Ratio of symptom free days during the trial	Baseline, week 12
Compare the change of ACQ to the baseline after the medication	Baseline, week 12	ACQ: Asthma Control Questionnaire

Trial Locations

Locations (1)

Ajou University Medical Center; 🇰🇷 Suwon, Korea, Republic of