Safety and Efficacy of YHD001 in Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424124
• Other study ID #: YHD001-201
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2011
• Last updated: July 8, 2014
• Start date: November 2011
• Est. completion date: January 2014

Study information

• Verified date: July 2014
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Description:

Singulair: Montelukast sodium (leukotriene modulator)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• YHD001 dose level 1
Tablet, three times daily / 8 weeks
• YHD001 dose level 2
Tablet, three times daily / 8 weeks
• Singulair
Tablet, one times daily / 8 weeks
• Placebo
Tablet, one times daily / 7 days

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of FEV1 at week 4	FEV1: Forced Expiratory Volume In One Second	Baseline, week 4	No
Secondary	Change from baseline of FEV1 at week 8		Baseline, week 8	No
Secondary	Change from baseline of PEFR at week 8	PEFR: Peak Expiratory Flow Rate	Baseline, week 8	No
Secondary	Change from baseline of ACT Score at week 8	ACT: Asthma control test	Baseline, week 8	No
Secondary	Change from baseline of using rescue medication(b-Agonist) at week 8		Baseline, week 8	Yes
Secondary	safety assessment	Comparison of the adverse event profiles throughout the course of the study	week 9	Yes