Safety and Efficacy of YHD001 in Asthma

Yuhan

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Singulair; Drug: YHD001 dose level 1; Drug: Placebo; Drug: YHD001 dose level 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01424124

YHD001-201

Details and patient eligibility

About

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.

Full description

Singulair: Montelukast sodium (leukotriene modulator)

Enrollment: 56 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 4 patient groups, including a placebo group

YHD001 dose level 1

Experimental group

Treatment:

Drug: YHD001 dose level 1

YHD001 dose level 2

Experimental group

Treatment:

Drug: YHD001 dose level 2

Singulair

Active Comparator group

Treatment:

Drug: Singulair

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo