Safety and Efficacy of YHD001 in Asthma

July 8, 2014 updated by: Yuhan Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Singulair: Montelukast sodium (leukotriene modulator)

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Tablet, one times daily / 7 days
Experimental: YHD001 dose level 1
Drug: YHD001 dose level 1
Tablet, three times daily / 8 weeks
Experimental: YHD001 dose level 2
Drug: YHD001 dose level 2
Tablet, three times daily / 8 weeks
Active Comparator: Singulair
Drug: Singulair
Tablet, one times daily / 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of FEV1 at week 4
Time Frame: Baseline, week 4
FEV1: Forced Expiratory Volume In One Second
Baseline, week 4

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuhan Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

August 24, 2011

First Submitted That Met QC Criteria

August 25, 2011

First Posted (Estimate)

August 26, 2011

Study Record Updates

Last Update Posted (Estimate)

July 10, 2014

Last Update Submitted That Met QC Criteria

July 8, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YHD001-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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