Safety and Efficacy of YHD001 in Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01424124
First received: August 24, 2011
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • Change from baseline of FEV1 at week 4 [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]
    FEV1: Forced Expiratory Volume In One Second


Secondary Outcome Measures:
  • Change from baseline of FEV1 at week 8 [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]
  • Change from baseline of PEFR at week 8 [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]
    PEFR: Peak Expiratory Flow Rate

  • Change from baseline of ACT Score at week 8 [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]
    ACT: Asthma control test

  • Change from baseline of using rescue medication(b-Agonist) at week 8 [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: Yes ]
  • safety assessment [ Time Frame: week 9 ] [ Designated as safety issue: Yes ]
    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)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
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: NCT01424124

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

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01424124     History of Changes
Other Study ID Numbers: YHD001-201
Study First Received: August 24, 2011
Last Updated: July 8, 2014
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014