Safety and Efficacy of WIN-901X in Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820481
• Other study ID #: WIN-901X-P2
• Status: Completed
• Phase: Phase 2
• First received: March 25, 2013
• Last updated: December 5, 2013
• Start date: September 2012
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: Whanin Pharmaceutical Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• WIN-901X dose level 1
100mg Bid, PO, 12weeks
• WIN-901X dose level 2
200mg Bid, PO, 12weeks
• WIN-901X dose level 3
300mg Bid, PO, 12weeks
• Placebo
Bid, PO, 12weeks

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Medical Center	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Whanin Pharmaceutical Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the change of FEV1% to the baseline after the medication	FEV1: Forced Expiratory Volume In One Second	Baseline, week 12	No
Secondary	Compare the change of ACQ to the baseline after the medication	ACQ: Asthma Control Questionnaire	Baseline, week 12	No
Secondary	Ratio of the date, where no rescue drug was used, during the trial		Baseline, week 12	No
Secondary	Ratio of symptom free days during the trial		Baseline, week 12	No