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Completed

NCT Number: NCT01820481

Safety and Efficacy of WIN-901X in Asthma

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ajou University Medical Center

Suwon, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WIN-901X dose level 1

Drug

100mg Bid, PO, 12weeks

WIN-901X dose level 2

Drug

200mg Bid, PO, 12weeks

WIN-901X dose level 3

Drug

300mg Bid, PO, 12weeks

Placebo

Drug

Bid, PO, 12weeks

Primary outcomes

  1. Compare the change of FEV1% to the baseline after the medication

    Time frame: Baseline, week 12

    FEV1: Forced Expiratory Volume In One Second

Secondary outcomes

  1. Compare the change of ACQ to the baseline after the medication

    Time frame: Baseline, week 12

    ACQ: Asthma Control Questionnaire

  2. Ratio of the date, where no rescue drug was used, during the trial

    Time frame: Baseline, week 12

  3. Ratio of symptom free days during the trial

    Time frame: Baseline, week 12

Sponsors and collaborators

Lead sponsor

Whanin Pharmaceutical Company

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 28, 2013
Registry last updated
Dec 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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