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Safety and Efficacy of WIN-901X in Asthma

NCT ID: NCT01820481

Last Updated: 2013-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-11-30

Brief Summary

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This clinical trial is designed to evaluate the efficacy, dose-response and safety of WIN-901X in Asthma patients.

Detailed Description

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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

Conditions

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Asthma

Keywords

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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment 1

Group Type EXPERIMENTAL

WIN-901X dose level 1

Intervention Type DRUG

100mg Bid, PO, 12weeks

Treatment 2

Group Type EXPERIMENTAL

WIN-901X dose level 2

Intervention Type DRUG

200mg Bid, PO, 12weeks

Treatment 3

Group Type EXPERIMENTAL

WIN-901X dose level 3

Intervention Type DRUG

300mg Bid, PO, 12weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Bid, PO, 12weeks

Interventions

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WIN-901X dose level 1

100mg Bid, PO, 12weeks

Intervention Type DRUG

WIN-901X dose level 2

200mg Bid, PO, 12weeks

Intervention Type DRUG

WIN-901X dose level 3

300mg Bid, PO, 12weeks

Intervention Type DRUG

Placebo

Bid, PO, 12weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Whanin Pharmaceutical Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Park Hae Sim, M.D., Professor

Role: STUDY_CHAIR

Yes

Locations

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Ajou University Medical Center

Suwon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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WIN-901X-P2

Identifier Type: -

Identifier Source: org_study_id