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
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, see Learn About Clinical Studies.

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 July 24, 2014