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Safety and Efficacy of YHD001 in Asthma

This study has been completed.
Information provided by (Responsible Party):
Yuhan Corporation Identifier:
First received: August 24, 2011
Last updated: July 8, 2014
Last verified: July 2014

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.

Condition Intervention Phase
Asthma Drug: YHD001 dose level 1 Drug: YHD001 dose level 2 Drug: Singulair Drug: Placebo Phase 2

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

Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • Change from baseline of FEV1 at week 4 [ Time Frame: Baseline, week 4 ]
    FEV1: Forced Expiratory Volume In One Second

Secondary Outcome Measures:
  • Change from baseline of FEV1 at week 8 [ Time Frame: Baseline, week 8 ]
  • Change from baseline of PEFR at week 8 [ Time Frame: Baseline, week 8 ]
    PEFR: Peak Expiratory Flow Rate

  • Change from baseline of ACT Score at week 8 [ Time Frame: Baseline, week 8 ]
    ACT: Asthma control test

  • Change from baseline of using rescue medication(b-Agonist) at week 8 [ Time Frame: Baseline, week 8 ]
  • safety assessment [ Time Frame: week 9 ]
    Comparison of the adverse event profiles throughout the course of the study

Enrollment: 56
Study Start Date: November 2011
Study Completion Date: January 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YHD001 dose level 1 Drug: YHD001 dose level 1
Tablet, three times daily / 8 weeks
Experimental: YHD001 dose level 2 Drug: YHD001 dose level 2
Tablet, three times daily / 8 weeks
Active Comparator: Singulair Drug: Singulair
Tablet, one times daily / 8 weeks
Placebo Comparator: Placebo Drug: Placebo
Tablet, one times daily / 7 days

Detailed Description:
Singulair: Montelukast sodium (leukotriene modulator)

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  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 identifier: NCT01424124

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
  More Information

Responsible Party: Yuhan Corporation Identifier: NCT01424124     History of Changes
Other Study ID Numbers: YHD001-201
Study First Received: August 24, 2011
Last Updated: July 8, 2014

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017