Safety and Efficacy of WIN-901X in Asthma
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
1 other identifier
interventional
209
1 country
1
Brief Summary
This clinical trial is designed to evaluate the efficacy, dose-response and safety of WIN-901X in Asthma patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Sep 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 25, 2013
CompletedFirst Posted
Study publicly available on registry
March 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedDecember 9, 2013
December 1, 2013
1.2 years
March 25, 2013
December 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare the change of FEV1% to the baseline after the medication
FEV1: Forced Expiratory Volume In One Second
Baseline, week 12
Secondary Outcomes (3)
Compare the change of ACQ to the baseline after the medication
Baseline, week 12
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
Study Arms (4)
Treatment 1
EXPERIMENTALTreatment 2
EXPERIMENTALTreatment 3
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ajou University Medical Center
Suwon, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Park Hae Sim, M.D., Professor
Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2013
First Posted
March 28, 2013
Study Start
September 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
December 9, 2013
Record last verified: 2013-12