Safety and Efficacy of YHD001 in Asthma

Yuhan Corporation56 enrolled

Overview

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.

Singulair: Montelukast sodium (leukotriene modulator)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Asthma

Interventions

YHD001 dose level 1DRUG

Tablet, three times daily / 8 weeks

YHD001 dose level 2DRUG

Tablet, three times daily / 8 weeks

SingulairDRUG

Tablet, one times daily / 8 weeks

Placebo

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Change from baseline of FEV1 at week 4

FEV1: Forced Expiratory Volume In One Second

Time frame: Baseline, week 4

Secondary Outcomes

Change from baseline of FEV1 at week 8

Time frame: Baseline, week 8

Change from baseline of PEFR at week 8

PEFR: Peak Expiratory Flow Rate

Time frame: Baseline, week 8

Change from baseline of ACT Score at week 8

ACT: Asthma control test

Time frame: Baseline, week 8

Change from baseline of using rescue medication(b-Agonist) at week 8

Time frame: Baseline, week 8

safety assessment

Comparison of the adverse event profiles throughout the course of the study

Time frame: week 9

Data from ClinicalTrials.gov

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