A Study of MK0359 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0359-016)

Pulmonary Disease, Chronic Obstructive Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482235
• Other study ID #: 0359-016
• Secondary ID: 2007_569
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2007
• Last updated: November 30, 2015
• Start date: December 2002
• Est. completion date: April 2003

Study information

• Verified date: November 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

A study to test the effect of MK0359 in lessening the symptoms of COPD as compared to salmeterol and placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2003
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• You are between the ages of 40 and 75

• You have had a history for at least a year of COPD symptoms

• You have a history of smoking one pack of cigarettes per day for 10 years

Exclusion Criteria:

• 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 2 months or hospitalized within the last 3 months for your COPD symptoms

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• MK0359

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Lu S, Liu N, Dass SB, Reiss TF, Knorr BA. Randomized, placebo-controlled study of a selective PDE4 inhibitor in the treatment of asthma. Respir Med. 2009 Mar;103(3):342-7. doi: 10.1016/j.rmed.2008.10.024. Epub 2009 Jan 8. — View Citation