Safety and Efficacy of WIN-901X in Asthma

December 5, 2013 updated by: Whanin Pharmaceutical Company

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

209

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Bid, PO, 12weeks
Experimental: Treatment 1
Drug: WIN-901X dose level 1
100mg Bid, PO, 12weeks
Experimental: Treatment 2
Drug: WIN-901X dose level 2
200mg Bid, PO, 12weeks
Experimental: Treatment 3
Drug: WIN-901X dose level 3
300mg Bid, PO, 12weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Whanin Pharmaceutical Company

Investigators

  • Study Chair: Park Hae Sim, M.D., Professor, yes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

March 25, 2013

First Submitted That Met QC Criteria

March 25, 2013

First Posted (Estimate)

March 28, 2013

Study Record Updates

Last Update Posted (Estimate)

December 9, 2013

Last Update Submitted That Met QC Criteria

December 5, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIN-901X-P2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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