- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01820481
Safety and Efficacy of WIN-901X in Asthma
December 5, 2013 updated by: Whanin Pharmaceutical Company
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
This clinical trial is designed to evaluate the efficacy, dose-response and safety of WIN-901X in Asthma patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
209
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Suwon, Korea, Republic of
- Ajou University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Bid, PO, 12weeks
|
Experimental: Treatment 1
|
100mg Bid, PO, 12weeks
|
Experimental: Treatment 2
|
200mg Bid, PO, 12weeks
|
Experimental: Treatment 3
|
300mg Bid, PO, 12weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare the change of FEV1% to the baseline after the medication
Time Frame: Baseline, week 12
|
FEV1: Forced Expiratory Volume In One Second
|
Baseline, week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare the change of ACQ to the baseline after the medication
Time Frame: Baseline, week 12
|
ACQ: Asthma Control Questionnaire
|
Baseline, week 12
|
Ratio of the date, where no rescue drug was used, during the trial
Time Frame: Baseline, week 12
|
Baseline, week 12
|
|
Ratio of symptom free days during the trial
Time Frame: Baseline, week 12
|
Baseline, week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Park Hae Sim, M.D., Professor, Yes
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
March 25, 2013
First Submitted That Met QC Criteria
March 25, 2013
First Posted (Estimate)
March 28, 2013
Study Record Updates
Last Update Posted (Estimate)
December 9, 2013
Last Update Submitted That Met QC Criteria
December 5, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WIN-901X-P2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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