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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00783601

Enrollment

130

Registered

2008-10-31

Start date

2004-10-31

Completion date

2005-05-31

Last updated

2015-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Chronic Asthma

Brief summary

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

Interventions

DRUGComparator: MK0524 + placebo

Two 150 mg MK0524 tablets + one placebo tablet in the matching image of montelukast 10 mg once daily for 3 weeks

DRUGComparator: MK0524 + montelukast

Two 150 mg MK0524 tablets and one 10 mg montelukast tablet once daily for 2 weeks

DRUGComparator: placebo + montelukast

Two placebo tablets in the matching image of MK0524 150 mg and one 10 mg tablet montelukast once daily for 2 weeks

DRUGComparator: 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026