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Safety and Efficacy of YHD001 in Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01424124
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : July 10, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Asthma Drug: YHD001 dose level 1 Drug: YHD001 dose level 2 Drug: Singulair Drug: Placebo Phase 2

Detailed Description:
Singulair: Montelukast sodium (leukotriene modulator)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
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
Study Start Date : November 2011
Primary Completion Date : June 2013
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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


Secondary Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424124


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

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01424124     History of Changes
Other Study ID Numbers: YHD001-201
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
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