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Safety and Efficacy of WIN-901X in Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01820481
First Posted: March 28, 2013
Last Update Posted: December 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Whanin Pharmaceutical Company
  Purpose
This clinical trial is designed to evaluate the efficacy, dose-response and safety of WIN-901X in Asthma patients.

Condition Intervention Phase
Asthma Drug: WIN-901X dose level 1 Drug: WIN-901X dose level 2 Drug: WIN-901X dose level 3 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Whanin Pharmaceutical Company:

Primary Outcome Measures:
  • Compare the change of FEV1% to the baseline after the medication [ Time Frame: Baseline, week 12 ]
    FEV1: Forced Expiratory Volume In One Second


Secondary Outcome Measures:
  • Compare the change of ACQ to the baseline after the medication [ Time Frame: Baseline, week 12 ]
    ACQ: Asthma Control Questionnaire

  • Ratio of the date, where no rescue drug was used, during the trial [ Time Frame: Baseline, week 12 ]
  • Ratio of symptom free days during the trial [ Time Frame: Baseline, week 12 ]

Enrollment: 209
Study Start Date: September 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: Placebo
Bid, PO, 12weeks

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01820481


Locations
Korea, Republic of
Ajou University Medical Center
Suwon, Korea, Republic of
Sponsors and Collaborators
Whanin Pharmaceutical Company
Investigators
Study Chair: Park Hae Sim, M.D., Professor Yes
  More Information

Responsible Party: Whanin Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT01820481     History of Changes
Other Study ID Numbers: WIN-901X-P2
First Submitted: March 25, 2013
First Posted: March 28, 2013
Last Update Posted: December 9, 2013
Last Verified: December 2013

Keywords provided by Whanin Pharmaceutical Company:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases