NCT00482235

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2002

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2007

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

4 months

First QC Date

June 1, 2007

Last Update Submit

November 30, 2015

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

MK0359DRUG

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 19135348RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2007

First Posted

June 5, 2007

Study Start

December 1, 2002

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

December 2, 2015

Record last verified: 2015-11