Back to resultsSafety and Efficacy of WIN-901X in Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
WIN-901X dose level 1
WIN-901X dose level 2
WIN-901X dose level 3
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases
Eligibility 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
Sites / Locations
- Ajou University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Treatment 1
Treatment 2
Treatment 3
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Compare the change of FEV1% to the baseline after the medication
FEV1: Forced Expiratory Volume In One Second
Secondary Outcome Measures
Compare the change of ACQ to the baseline after the medication
ACQ: Asthma Control Questionnaire
Ratio of the date, where no rescue drug was used, during the trial
Ratio of symptom free days during the trial
Full Information
NCT ID
NCT01820481
First Posted
March 25, 2013
Last Updated
December 5, 2013
Sponsor
Whanin Pharmaceutical Company
1. Study Identification
Unique Protocol Identification Number
NCT01820481
Brief Title
Safety and Efficacy of WIN-901X in Asthma
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Whanin Pharmaceutical Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
209 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment 1
Arm Type
Experimental
Arm Title
Treatment 2
Arm Type
Experimental
Arm Title
Treatment 3
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
WIN-901X dose level 1
Intervention Description
100mg Bid, PO, 12weeks
Intervention Type
Drug
Intervention Name(s)
WIN-901X dose level 2
Intervention Description
200mg Bid, PO, 12weeks
Intervention Type
Drug
Intervention Name(s)
WIN-901X dose level 3
Intervention Description
300mg Bid, PO, 12weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Bid, PO, 12weeks
Primary Outcome Measure Information:
Title
Compare the change of FEV1% to the baseline after the medication
Description
FEV1: Forced Expiratory Volume In One Second
Time Frame
Baseline, week 12
Secondary Outcome Measure Information:
Title
Compare the change of ACQ to the baseline after the medication
Description
ACQ: Asthma Control Questionnaire
Time Frame
Baseline, week 12
Title
Ratio of the date, where no rescue drug was used, during the trial
Time Frame
Baseline, week 12
Title
Ratio of symptom free days during the trial
Time Frame
Baseline, week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Park Hae Sim, M.D., Professor
Organizational Affiliation
Yes
Official's Role
Study Chair
Facility Information:
Facility Name
Ajou University Medical Center
City
Suwon
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of WIN-901X in Asthma
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