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Completed

NCT Number: NCT01424124

Safety and Efficacy of YHD001 in Asthma

The main objective is to evaluate the safety/tolerability and efficacy of YHD001 compared to singulair or placebo in patients (n=96) with partially controlled asthma.

The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), singulair 10mg(q.d.) or Placebo for 8 weeks.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

Singulair: Montelukast sodium (leukotriene modulator)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of signed written informed consent
  • Acceptable medical history, physical exam,laboratory tests and EKG, during screening
  • Nonsmoking (for longer than 1 year) patients with asthma
  • Reversible airways obstruction (an increase in FEV1 absolute value of 12% or greater) 20 to 30 minutes after inhalation of b-agonist
  • FEV1 between 50% and 85% of the predicted value (withholding short-acting, inhaled b2-adrenergic agonist for 6 hours)

Exclusion criteria

  • History of any clinically significant disease
  • History of drug/chemical/alcohol abuse
  • Active upper respiratory tract infection within 3 weeks, emergency room treatment for asthma within 1 month, or hospitalization for asthma within 3 months of the prestudy visit

Treatment and study plan

YHD001 dose level 1

Drug

Tablet, three times daily / 8 weeks

YHD001 dose level 2

Drug

Tablet, three times daily / 8 weeks

Singulair

Drug

Tablet, one times daily / 8 weeks

Placebo

Drug

Tablet, one times daily / 7 days

Primary outcomes

  1. Change from baseline of FEV1 at week 4

    Time frame: Baseline, week 4

    FEV1: Forced Expiratory Volume In One Second

Secondary outcomes

  1. Change from baseline of FEV1 at week 8

    Time frame: Baseline, week 8

  2. Change from baseline of PEFR at week 8

    Time frame: Baseline, week 8

    PEFR: Peak Expiratory Flow Rate

  3. Change from baseline of ACT Score at week 8

    Time frame: Baseline, week 8

    ACT: Asthma control test

  4. Change from baseline of using rescue medication(b-Agonist) at week 8

    Time frame: Baseline, week 8

  5. safety assessment

    Time frame: week 9

    Comparison of the adverse event profiles throughout the course of the study

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

Randomized, Double-blind, Placebo/Active-controlled, Multi-center Clinical Trial to Investigate the Safety/Tolerability and Efficacy of YHD001 Following 8 Weeks Oral Administration of YHD001 in Patients With Partially Controlled Asthma

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Aug 26, 2011
Registry last updated
Jul 10, 2014

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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