Safety and Efficacy of WIN-901X in Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Whanin Pharmaceutical Company
ClinicalTrials.gov Identifier:
NCT01820481
First received: March 25, 2013
Last updated: December 5, 2013
Last verified: December 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    ACQ: Asthma Control Questionnaire

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

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

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Whanin Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT01820481     History of Changes
Other Study ID Numbers: WIN-901X-P2
Study First Received: March 25, 2013
Last Updated: December 5, 2013
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014