NCT00482898

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for phase_2 asthma

Timeline
Completed

Started Sep 2002

Shorter than P25 for phase_2 asthma

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

September 1, 2002

Completed
7 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

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

7 months

First QC Date

June 1, 2007

Last Update Submit

May 26, 2015

Conditions

Asthma

Interventions

MK0359DRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

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: 19135348BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2007

First Posted

June 5, 2007

Study Start

September 1, 2002

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

May 27, 2015

Record last verified: 2015-05