Safety and Efficacy of YHD001 in Asthma
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
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 asthma
Started Nov 2011
Typical duration for phase_2 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2011
CompletedFirst Posted
Study publicly available on registry
August 26, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedJuly 10, 2014
July 1, 2014
1.6 years
August 24, 2011
July 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline of FEV1 at week 4
FEV1: Forced Expiratory Volume In One Second
Baseline, week 4
Secondary Outcomes (5)
Change from baseline of FEV1 at week 8
Baseline, week 8
Change from baseline of PEFR at week 8
Baseline, week 8
Change from baseline of ACT Score at week 8
Baseline, week 8
Change from baseline of using rescue medication(b-Agonist) at week 8
Baseline, week 8
safety assessment
week 9
Study Arms (4)
YHD001 dose level 1
EXPERIMENTALYHD001 dose level 2
EXPERIMENTALSingulair
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2011
First Posted
August 26, 2011
Study Start
November 1, 2011
Primary Completion
June 1, 2013
Study Completion
January 1, 2014
Last Updated
July 10, 2014
Record last verified: 2014-07