A Study of MK0359 in Patients With Chronic Asthma (0359-013) | NCT00482898

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

NCT00482898

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

May 27, 2015Estimated

Enrollment

56Actual

Phase

Phase 2

Conditions

Asthma

Interventions

MK0359

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2002

Primary Completion Date

Apr 2003Actual

Completion Date

Apr 2003Actual

First Submitted Date

Jun 1, 2007

First Submission Date that Met QC Criteria

Jun 1, 2007

First Posted Date

Jun 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2015

Last Update Posted Date

May 27, 2015Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Name	Type	Description	Arm Group Labels	Other Names
MK0359	Drug

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19135348	Background	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.

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

ID	Type	Description	Link
MK0359-013
2007_575