Back to resultsSafety and Efficacy of YHD001 in Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YHD001 dose level 1
YHD001 dose level 2
Singulair
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility 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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
YHD001 dose level 1
YHD001 dose level 2
Singulair
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline of FEV1 at week 4
FEV1: Forced Expiratory Volume In One Second
Secondary Outcome Measures
Change from baseline of FEV1 at week 8
Change from baseline of PEFR at week 8
PEFR: Peak Expiratory Flow Rate
Change from baseline of ACT Score at week 8
ACT: Asthma control test
Change from baseline of using rescue medication(b-Agonist) at week 8
safety assessment
Comparison of the adverse event profiles throughout the course of the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01424124
Brief Title
Safety and Efficacy of YHD001 in Asthma
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 Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation
4. Oversight
Data Monitoring Committee
No
5. 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.
Detailed Description
Singulair: Montelukast sodium (leukotriene modulator)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
YHD001 dose level 1
Arm Type
Experimental
Arm Title
YHD001 dose level 2
Arm Type
Experimental
Arm Title
Singulair
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
YHD001 dose level 1
Intervention Description
Tablet, three times daily / 8 weeks
Intervention Type
Drug
Intervention Name(s)
YHD001 dose level 2
Intervention Description
Tablet, three times daily / 8 weeks
Intervention Type
Drug
Intervention Name(s)
Singulair
Intervention Description
Tablet, one times daily / 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet, one times daily / 7 days
Primary Outcome Measure Information:
Title
Change from baseline of FEV1 at week 4
Description
FEV1: Forced Expiratory Volume In One Second
Time Frame
Baseline, week 4
Secondary Outcome Measure Information:
Title
Change from baseline of FEV1 at week 8
Time Frame
Baseline, week 8
Title
Change from baseline of PEFR at week 8
Description
PEFR: Peak Expiratory Flow Rate
Time Frame
Baseline, week 8
Title
Change from baseline of ACT Score at week 8
Description
ACT: Asthma control test
Time Frame
Baseline, week 8
Title
Change from baseline of using rescue medication(b-Agonist) at week 8
Time Frame
Baseline, week 8
Title
safety assessment
Description
Comparison of the adverse event profiles throughout the course of the study
Time Frame
week 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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Safety and Efficacy of YHD001 in Asthma
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