A Study of MK0359 in Patients With Chronic Asthma (0359-013)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00482898
First received: June 1, 2007
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

A study to test the effect of MK0359 in lessening the symptoms of asthma as compared to placebo.


Condition Intervention Phase
Asthma
Drug: MK0359
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Crossover Study Comparing the Effect of MK0359 and Placebo in Adult Patients With Chronic Asthma

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Study Start Date: October 2002
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • You are between the ages of 18 and 45
  • You have had a history for at least a year of COPD symptoms
  • Your current asthma treatment is limited to short-acting beta-agonists(such as albuterol)
  • You have a history of smoking one pack of cigarettes per day for 7 years
  • You will not be away from home for more than 5 days during the study

Exclusion Criteria:

  • You are unwilling to limit your alcohol use to less than 5 drinks per week
  • You have been in a research study with an investigational drug or vaccine in the last 4 weeks
  • You have donated blood in the last 4 weeks
  • You have been hospitalized or had major surgery in the last 4 weeks
  • You have been treated in the emergency room within the last 4 weeks or hospitalized within the last 3 months for your asthma
  • You have a history of heart problems in the last 6 months
  • You have a history of stomach problems
  • You are unwilling to avoid grapefruit juice throughout the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482898

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00482898     History of Changes
Other Study ID Numbers: 0359-013, MK0359-013, 2007_575
Study First Received: June 1, 2007
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014