NCT00103922

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

115 active sites

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

November 1, 2004

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

2.2 years

First QC Date

February 17, 2005

Last Update Submit

October 26, 2016

Conditions

Keywords

smokers cough

Outcome Measures

Primary Outcomes (1)

  • measure of lung function and quality of life in patients with COPD

Secondary Outcomes (1)

  • exacerbations in patients with COPD

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: cilomilast

Interventions

Arm 1

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of COPD and a history of cigarette smoking.

You may not qualify if:

  • Significant heart or lung disease not associated with COPD.
  • Significant stomach or intestinal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (115)

GSK Investigational Site

Birmingham, Alabama, 35209, United States

Location

GSK Investigational Site

Jasper, Alabama, 35501, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85006, United States

Location

GSK Investigational Site

Tempe, Arizona, 85282, United States

Location

GSK Investigational Site

Berkeley, California, 94705, United States

Location

GSK Investigational Site

Carmichael, California, 95608, United States

Location

GSK Investigational Site

Fullerton, California, 92835, United States

Location

GSK Investigational Site

Long Beach, California, 90806, United States

Location

GSK Investigational Site

Long Beach, California, 90822, United States

Location

GSK Investigational Site

Los Angeles, California, 90048, United States

Location

GSK Investigational Site

Murrieta, California, 92562, United States

Location

GSK Investigational Site

Rancho Mirage, California, 92270, United States

Location

GSK Investigational Site

Riverside, California, 92805, United States

Location

GSK Investigational Site

Sacramento, California, 95823, United States

Location

GSK Investigational Site

San Diego, California, 92103, United States

Location

GSK Investigational Site

San Diego, California, 92120, United States

Location

GSK Investigational Site

San Jose, California, 95117, United States

Location

GSK Investigational Site

Sepulveda, California, 91343, United States

Location

GSK Investigational Site

Stockton, California, 95207, United States

Location

GSK Investigational Site

Torrance, California, 90509, United States

Location

GSK Investigational Site

Vista, California, 92083, United States

Location

GSK Investigational Site

Walnut Creek, California, 94598, United States

Location

GSK Investigational Site

Boulder, Colorado, 80304, United States

Location

GSK Investigational Site

Colorado Springs, Colorado, 80907, United States

Location

GSK Investigational Site

Denver, Colorado, 80230, United States

Location

GSK Investigational Site

Englewood, Colorado, 80112, United States

Location

GSK Investigational Site

Fort Collins, Colorado, 80528, United States

Location

GSK Investigational Site

Wheat Ridge, Colorado, 80033, United States

Location

GSK Investigational Site

Hartford, Connecticut, 06105, United States

Location

GSK Investigational Site

Stamford, Connecticut, 06902, United States

Location

GSK Investigational Site

Waterbury, Connecticut, 06708, United States

Location

GSK Investigational Site

Aventura, Florida, 33180, United States

Location

GSK Investigational Site

Brandon, Florida, 33511, United States

Location

GSK Investigational Site

DeLand, Florida, 32720, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33316, United States

Location

GSK Investigational Site

Largo, Florida, 33770, United States

Location

GSK Investigational Site

Longwood, Florida, 32779, United States

Location

GSK Investigational Site

Melbourne, Florida, 32935, United States

Location

GSK Investigational Site

Panama City, Florida, 32405, United States

Location

GSK Investigational Site

Pensacola, Florida, 32504, United States

Location

GSK Investigational Site

Tamarac, Florida, 33321, United States

Location

GSK Investigational Site

Tampa, Florida, 33613, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33409, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30342, United States

Location

GSK Investigational Site

Decatur, Georgia, 30033, United States

Location

GSK Investigational Site

Coeur d'Alene, Idaho, 83814, United States

Location

GSK Investigational Site

Normal, Illinois, 61761, United States

Location

GSK Investigational Site

Evansville, Indiana, 47710, United States

Location

GSK Investigational Site

South Bend, Indiana, 46617, United States

Location

GSK Investigational Site

Wichita, Kansas, 67207, United States

Location

GSK Investigational Site

Madisonville, Kentucky, 42431, United States

Location

GSK Investigational Site

Lafayette, Louisiana, 70503, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70119, United States

Location

GSK Investigational Site

Slidell, Louisiana, 70461, United States

Location

GSK Investigational Site

Sunset, Louisiana, 70584, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02135, United States

Location

GSK Investigational Site

Cadillac, Michigan, 49601, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55402, United States

Location

GSK Investigational Site

Jefferson City, Missouri, 65109, United States

Location

GSK Investigational Site

Saint Charles, Missouri, 63301, United States

Location

GSK Investigational Site

St Louis, Missouri, 63122, United States

Location

GSK Investigational Site

St Louis, Missouri, 63141, United States

Location

GSK Investigational Site

Billings, Montana, 59102, United States

Location

GSK Investigational Site

Missoula, Montana, 59808, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89104, United States

Location

GSK Investigational Site

Cherry Hill, New Jersey, 08003, United States

Location

GSK Investigational Site

Bronxville, New York, 10708, United States

Location

GSK Investigational Site

Cortland, New York, 14850, United States

Location

GSK Investigational Site

Larchmont, New York, 10538, United States

Location

GSK Investigational Site

New York, New York, 10016, United States

Location

GSK Investigational Site

Chapel Hill, North Carolina, 27599, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28207, United States

Location

GSK Investigational Site

Elizabeth City, North Carolina, 27909, United States

Location

GSK Investigational Site

High Point, North Carolina, 27262, United States

Location

GSK Investigational Site

Statesville, North Carolina, 28625, United States

Location

GSK Investigational Site

Chardon, Ohio, 44024, United States

Location

GSK Investigational Site

Columbus, Ohio, 43215, United States

Location

GSK Investigational Site

Dayton, Ohio, 45406, United States

Location

GSK Investigational Site

Sylvania, Ohio, 43560, United States

Location

GSK Investigational Site

Lake Oswego, Oregon, 97035, United States

Location

GSK Investigational Site

Medford, Oregon, 97504, United States

Location

GSK Investigational Site

Portland, Oregon, 97213, United States

Location

GSK Investigational Site

Allentown, Pennsylvania, 18103, United States

Location

GSK Investigational Site

Downington, Pennsylvania, 19335, United States

Location

GSK Investigational Site

Elverson, Pennsylvania, 19520, United States

Location

GSK Investigational Site

Erie, Pennsylvania, 16508, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15218, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15243, United States

Location

GSK Investigational Site

Swarthmore, Pennsylvania, 19081, United States

Location

GSK Investigational Site

East Providence, Rhode Island, 02914, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29406-7108, United States

Location

GSK Investigational Site

Gaffney, South Carolina, 29340, United States

Location

GSK Investigational Site

Greer, South Carolina, 29651, United States

Location

GSK Investigational Site

Simpsonville, South Carolina, 29681, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Bristol, Tennessee, 37620, United States

Location

GSK Investigational Site

Chattanooga, Tennessee, 37403, United States

Location

GSK Investigational Site

Johnson City, Tennessee, 37601, United States

Location

GSK Investigational Site

Knoxville, Tennessee, 37920, United States

Location

GSK Investigational Site

Corsicana, Texas, 75110, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76104, United States

Location

GSK Investigational Site

San Antonio, Texas, 78205, United States

Location

GSK Investigational Site

San Antonio, Texas, 78217, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84102, United States

Location

GSK Investigational Site

Richmond, Virginia, 23225, United States

Location

GSK Investigational Site

Richmond, Virginia, 23229, United States

Location

GSK Investigational Site

Bellingham, Washington, 98225, United States

Location

GSK Investigational Site

Spokane, Washington, 99204, United States

Location

GSK Investigational Site

Spokane, Washington, 99207, United States

Location

GSK Investigational Site

Tacoma, Washington, 98405, United States

Location

GSK Investigational Site

Morgantown, West Virginia, 26505, United States

Location

GSK Investigational Site

Milwaukee, Wisconsin, 53209-0996, United States

Location

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Cilomilast

Condition Hierarchy (Ancestors)

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

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2005

First Posted

February 18, 2005

Study Start

November 1, 2004

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

October 28, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Available IPD Datasets

Statistical Analysis Plan (CIL103657)Access
Study Protocol (CIL103657)Access
Clinical Study Report (CIL103657)Access
Informed Consent Form (CIL103657)Access
Individual Participant Data Set (CIL103657)Access
Dataset Specification (CIL103657)Access

Locations