Safety and Efficacy of WIN-901X in Asthma | NCT01820481

Studies
Safety and Efficacy of WIN-901X in Asthma

NCT01820481

Sponsor

Whanin Pharmaceutical Company

Status

Completed

Last Update Posted

Dec 9, 2013Estimated

Enrollment

209Actual

Phase

Phase 2

Conditions

Asthma

Interventions

WIN-901X dose level 1
WIN-901X dose level 2
WIN-901X dose level 3
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Mar 25, 2013

First Submission Date that Met QC Criteria

Mar 25, 2013

First Posted Date

Mar 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2013

Last Update Posted Date

Dec 9, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

209Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Treatment 1	Experimental	Drug: WIN-901X dose level 1
Treatment 2	Experimental	Drug: WIN-901X dose level 2
Treatment 3	Experimental	Drug: WIN-901X dose level 3
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
WIN-901X dose level 1	Drug	100mg Bid, PO, 12weeks	Treatment 1
WIN-901X dose level 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Compare the change of ACQ to the baseline after the medication	ACQ: Asthma Control Questionnaire	Baseline, week 12
Ratio of the date, where no rescue drug was used, during the trial		Baseline, week 12

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Park Hae Sim, M.D., Professor	Yes	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ajou University Medical Center		Suwon			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Ancestor Terms

ID	Term
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided