Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease)

NCT ID: NCT00103922

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-01-31

Brief Summary

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This study was designed to determine if the investigational drug is effective and safe in individuals with COPD (chronic pulmonary disease)

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Keywords

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smokers cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

cilomilast

Intervention Type DRUG

Interventions

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cilomilast

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of COPD and a history of cigarette smoking.

Exclusion Criteria

* Significant heart or lung disease not associated with COPD.
* Significant stomach or intestinal disease.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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Jasper, Alabama, United States

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Phoenix, Arizona, United States

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Tempe, Arizona, United States

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Berkeley, California, United States

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Carmichael, California, United States

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Fullerton, California, United States

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Long Beach, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Murrieta, California, United States

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Rancho Mirage, California, United States

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Riverside, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Jose, California, United States

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Sepulveda, California, United States

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Stockton, California, United States

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Torrance, California, United States

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Vista, California, United States

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Walnut Creek, California, United States

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Boulder, Colorado, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Englewood, Colorado, United States

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Fort Collins, Colorado, United States

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Wheat Ridge, Colorado, United States

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Hartford, Connecticut, United States

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Stamford, Connecticut, United States

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Waterbury, Connecticut, United States

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Aventura, Florida, United States

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Brandon, Florida, United States

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DeLand, Florida, United States

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Fort Lauderdale, Florida, United States

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Largo, Florida, United States

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Longwood, Florida, United States

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Melbourne, Florida, United States

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Panama City, Florida, United States

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Pensacola, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Coeur d'Alene, Idaho, United States

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Normal, Illinois, United States

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Evansville, Indiana, United States

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South Bend, Indiana, United States

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Wichita, Kansas, United States

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Madisonville, Kentucky, United States

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Lafayette, Louisiana, United States

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New Orleans, Louisiana, United States

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Slidell, Louisiana, United States

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Sunset, Louisiana, United States

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Boston, Massachusetts, United States

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Cadillac, Michigan, United States

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Minneapolis, Minnesota, United States

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Jefferson City, Missouri, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Missoula, Montana, United States

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Las Vegas, Nevada, United States

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Cherry Hill, New Jersey, United States

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Bronxville, New York, United States

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Cortland, New York, United States

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Larchmont, New York, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Elizabeth City, North Carolina, United States

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High Point, North Carolina, United States

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Statesville, North Carolina, United States

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Chardon, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Sylvania, Ohio, United States

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Lake Oswego, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Downington, Pennsylvania, United States

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Elverson, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Swarthmore, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Gaffney, South Carolina, United States

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Greer, South Carolina, United States

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Simpsonville, South Carolina, United States

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Spartanburg, South Carolina, United States

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Bristol, Tennessee, United States

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Chattanooga, Tennessee, United States

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Johnson City, Tennessee, United States

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Knoxville, Tennessee, United States

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Corsicana, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Bellingham, Washington, United States

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Spokane, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Morgantown, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

Study Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Document Type: Clinical Study Report

View Document

Document Type: Informed Consent Form

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Dataset Specification

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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CIL103657

Identifier Type: -

Identifier Source: org_study_id