Safety and Efficacy of YHD001 in Asthma

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: YHD001 dose level 1; Drug: Singulair; Drug: Placebo; Drug: YHD001 dose level 2

• Registration Number: NCT01424124
• Lead Sponsor: Yuhan Corporation

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)

Study Timeline

• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-08-25
• Study First Posted: 2011-08-26
• Study Start: 2011-11
• Primary Completion: 2013-06
• Study Completion: 2014-01
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-08
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YHD001 dose level 1	YHD001 dose level 1	-
Singulair	Singulair	-
Placebo	Placebo	-
YHD001 dose level 2	YHD001 dose level 2	-

Primary Outcome Measures

Name	Time	Method
Change from baseline of FEV1 at week 4	Baseline, week 4	FEV1: Forced Expiratory Volume In One Second

Secondary Outcome Measures

Name	Time	Method
Change from baseline of PEFR at week 8	Baseline, week 8	PEFR: Peak Expiratory Flow Rate
Change from baseline of ACT Score at week 8	Baseline, week 8	ACT: Asthma control test
Change from baseline of using rescue medication(b-Agonist) at week 8	Baseline, week 8
safety assessment	week 9	Comparison of the adverse event profiles throughout the course of the study
Change from baseline of FEV1 at week 8	Baseline, week 8

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of