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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01820481

Enrollment

209

Registered

2013-03-28

Start date

2012-09-30

Completion date

2013-11-30

Last updated

2013-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

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

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

Interventions

DRUGWIN-901X dose level 1

100mg Bid, PO, 12weeks

DRUGWIN-901X dose level 2

200mg Bid, PO, 12weeks

DRUGWIN-901X dose level 3

300mg Bid, PO, 12weeks

DRUGPlacebo

Bid, PO, 12weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Compare the change of ACQ to the baseline after the medication	Baseline, week 12	ACQ: Asthma Control Questionnaire
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	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026