MK0524 Asthma POC Study (0524-008)(COMPLETED)

October 15, 2015 updated by: Merck Sharp & Dohme LLC

A Multicenter, Randomized, Double Blind, Crossover Study Comparing the Effect of MK0524 With Placebo and Concomitant Administration of MK0524 Plus Montelukast in Adult Patients With Chronic Asthma

The purpose of the study is to demonstrate the benefit of MK0524 compared to placebo in patients with chronic asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 2

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has symptoms of chronic asthma (shortness of breath, wheezing, chest tightness, etc.) for at least 1 year
  • Nonsmoker for at least 1 year with a smoking history of no more than 7 pack-years (i.e., 1 pack per day for 7 years)

Exclusion Criteria:

  • Any clinically significant disease of heart, intestinal, kidney, liver, lung or uncontrolled blood pressure
  • Any surgery within 4 weeks prior to Visit 1
  • Patient is intending to move or vacation for more than 5 days during the study
  • Patient is pregnant or breast-feeding

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Treatment Sequence 1: MK0524 + placebo, MK0524 + montelukast, placebo, placebo, placebo + montelukast
Drug: Comparator: MK0524 + placebo
Two 150 mg MK0524 tablets + one placebo tablet in the matching image of montelukast 10 mg once daily for 3 weeks
Drug: Comparator: MK0524 + montelukast
Two 150 mg MK0524 tablets and one 10 mg montelukast tablet once daily for 2 weeks
Drug: Comparator: placebo + montelukast
Two placebo tablets in the matching image of MK0524 150 mg and one 10 mg tablet montelukast once daily for 2 weeks
Drug: Comparator: Placebo
During the double-blind treatment periods, patients receive either two placebo tablets in the matching image of MK0524 150 mg or one placebo tablet in the matching image of montelukast 10 mg in a crossover manner. During the washout period before the crossover to the opposite treatment sequence, patients receive two placebo tablets in the matching image of MK0524 150 mg and one placebo tablet in the matching image of montelukast 10 mg once daily for two weeks.
Experimental: 2
Treatment sequence 2: Placebo, montelukast, placebo, MK0524, MK0524 + montelukast
Drug: Comparator: MK0524 + placebo
Two 150 mg MK0524 tablets + one placebo tablet in the matching image of montelukast 10 mg once daily for 3 weeks
Drug: Comparator: MK0524 + montelukast
Two 150 mg MK0524 tablets and one 10 mg montelukast tablet once daily for 2 weeks
Drug: Comparator: placebo + montelukast
Two placebo tablets in the matching image of MK0524 150 mg and one 10 mg tablet montelukast once daily for 2 weeks
Drug: Comparator: Placebo
During the double-blind treatment periods, patients receive either two placebo tablets in the matching image of MK0524 150 mg or one placebo tablet in the matching image of montelukast 10 mg in a crossover manner. During the washout period before the crossover to the opposite treatment sequence, patients receive two placebo tablets in the matching image of MK0524 150 mg and one placebo tablet in the matching image of montelukast 10 mg once daily for two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To demonstrate benefits of MK0524 compared with placebo on Forced Expiratory Volume in 1 second (FEV1)
Time Frame: Last 2 weeks of each treatment period
Last 2 weeks of each treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the benefits of MK0524 as compared with placebo on the key secondary endpoints (Daytime & Nighttime Asthma Symptoms scores
Time Frame: Last 2 weeks of each treatment period
Last 2 weeks of each treatment period

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2004

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

October 30, 2008

First Submitted That Met QC Criteria

October 30, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Estimate)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 15, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0524-008
  • MK0524-008
  • 2007_614

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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