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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Comparator: Placebo; Drug: Comparator: MK0524 + montelukast; Drug: Comparator: placebo + montelukast; Drug: Comparator: MK0524 + placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00783601

2007_614

MK0524-008

0524-008

Details and patient eligibility

About

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

Enrollment: 130 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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130 participants in 2 patient groups

1

Experimental group

Description:

Treatment Sequence 1: MK0524 + placebo, MK0524 + montelukast, placebo, placebo, placebo + montelukast

Treatment:

Drug: Comparator: MK0524 + montelukast

Drug: Comparator: Placebo

Drug: Comparator: placebo + montelukast

Drug: Comparator: MK0524 + placebo

2

Experimental group

Description:

Treatment sequence 2: Placebo, montelukast, placebo, MK0524, MK0524 + montelukast

Treatment:

Drug: Comparator: MK0524 + montelukast

Drug: Comparator: Placebo

Drug: Comparator: placebo + montelukast

Drug: Comparator: MK0524 + placebo