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Completed

NCT Number: NCT00783601

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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: MK0524 + placebo

Drug

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

Comparator: MK0524 + montelukast

Drug

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

Comparator: placebo + montelukast

Drug

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

Comparator: placebo

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Oct 31, 2008
Registry last updated
Oct 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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