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

Merck Sharp & Dohme LLC0 sites130 target enrollmentOctober 2004

ConditionsAsthma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Asthma
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 130
Primary Endpoint: To demonstrate benefits of MK0524 compared with placebo on Forced Expiratory Volume in 1 second (FEV1)
Status: Completed
Last Updated: 10 years ago

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

Registry

clinicaltrials.gov

Start Date

October 2004

End Date

May 2005

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Sponsor

Responsible Party

Sponsor

•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)

•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

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

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