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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783601
• Other study ID #: 0524-008
• Secondary ID: MK0524-0082007_6
• Status: Completed
• Phase: Phase 2
• First received: October 30, 2008
• Last updated: October 15, 2015
• Start date: October 2004
• Est. completion date: May 2005

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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
• Comparator: MK0524 + montelukast
Two 150 mg MK0524 tablets and one 10 mg montelukast tablet once daily for 2 weeks
• 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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate benefits of MK0524 compared with placebo on Forced Expiratory Volume in 1 second (FEV1)		Last 2 weeks of each treatment period	No
Secondary	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	No