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

Asthma Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Crossover Study Comparing the Effect of MK0359 and Placebo in Adult Patients With Chronic Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482898
• Other study ID #: 0359-013
• Secondary ID: MK0359-0132007_5
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2007
• Last updated: May 26, 2015
• Start date: September 2002
• Est. completion date: April 2003

Study information

• Verified date: May 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 asthma as compared to placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 2003
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

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:
• 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