CClinicalTrials.gg
CompletedNCT00103922Updated Oct 28, 2016

Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease)

A Phase 3 interventional study of cilomilast in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 115 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2016-10-28.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Pulmonary Disease, Chronic Obstructive

Keywords

  • smokers cough
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 600 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,561 studies on the registry; 116 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of COPD and a history of cigarette smoking.

Exclusion criteria

Exclusion criteria:

  • Significant heart or lung disease not associated with COPD.
  • Significant stomach or intestinal disease.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
600 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: cilomilast

Interventions

  • Drugcilomilast
06

What researchers measure

Primary outcomes

  1. measure of lung function and quality of life in patients with COPD

Secondary outcomes

  1. exacerbations in patients with COPD

07

Study locations

115 sites
  • GSK Investigational Site
    Birmingham, Alabama 35209, United States
  • GSK Investigational Site
    Jasper, Alabama 35501, United States
  • GSK Investigational Site
    Phoenix, Arizona 85006, United States
  • GSK Investigational Site
    Tempe, Arizona 85282, United States
  • GSK Investigational Site
    Berkeley, California 94705, United States
  • GSK Investigational Site
    Carmichael, California 95608, United States
  • GSK Investigational Site
    Fullerton, California 92835, United States
  • GSK Investigational Site
    Long Beach, California 90806, United States
  • GSK Investigational Site
    Long Beach, California 90822, United States
  • GSK Investigational Site
    Los Angeles, California 90048, United States
  • GSK Investigational Site
    Murrieta, California 92562, United States
  • GSK Investigational Site
    Rancho Mirage, California 92270, United States
  • GSK Investigational Site
    Riverside, California 92805, United States
  • GSK Investigational Site
    Sacramento, California 95823, United States
  • GSK Investigational Site
    San Diego, California 92103, United States
  • GSK Investigational Site
    San Diego, California 92120, United States
  • GSK Investigational Site
    San Jose, California 95117, United States
  • GSK Investigational Site
    Sepulveda, California 91343, United States
  • GSK Investigational Site
    Stockton, California 95207, United States
  • GSK Investigational Site
    Torrance, California 90509, United States
  • GSK Investigational Site
    Vista, California 92083, United States
  • GSK Investigational Site
    Walnut Creek, California 94598, United States
  • GSK Investigational Site
    Boulder, Colorado 80304, United States
  • GSK Investigational Site
    Colorado Springs, Colorado 80907, United States
  • GSK Investigational Site
    Denver, Colorado 80230, United States
  • GSK Investigational Site
    Englewood, Colorado 80112, United States
  • GSK Investigational Site
    Fort Collins, Colorado 80528, United States
  • GSK Investigational Site
    Wheat Ridge, Colorado 80033, United States
  • GSK Investigational Site
    Hartford, Connecticut 06105, United States
  • GSK Investigational Site
    Stamford, Connecticut 06902, United States
  • GSK Investigational Site
    Waterbury, Connecticut 06708, United States
  • GSK Investigational Site
    Aventura, Florida 33180, United States
  • GSK Investigational Site
    Brandon, Florida 33511, United States
  • GSK Investigational Site
    Deland, Florida 32720, United States
  • GSK Investigational Site
    Fort Lauderdale, Florida 33316, United States
  • GSK Investigational Site
    Largo, Florida 33770, United States
  • GSK Investigational Site
    Longwood, Florida 32779, United States
  • GSK Investigational Site
    Melbourne, Florida 32935, United States
  • GSK Investigational Site
    Panama City, Florida 32405, United States
  • GSK Investigational Site
    Pensacola, Florida 32504, United States
  • GSK Investigational Site
    Tamarac, Florida 33321, United States
  • GSK Investigational Site
    Tampa, Florida 33613, United States
  • GSK Investigational Site
    West Palm Beach, Florida 33409, United States
  • GSK Investigational Site
    Atlanta, Georgia 30342, United States
  • GSK Investigational Site
    Decatur, Georgia 30033, United States
  • GSK Investigational Site
    Coeur D'Alene, Idaho 83814, United States
  • GSK Investigational Site
    Normal, Illinois 61761, United States
  • GSK Investigational Site
    Evansville, Indiana 47710, United States
  • GSK Investigational Site
    South Bend, Indiana 46617, United States
  • GSK Investigational Site
    Wichita, Kansas 67207, United States
  • GSK Investigational Site
    Madisonville, Kentucky 42431, United States
  • GSK Investigational Site
    Lafayette, Louisiana 70503, United States
  • GSK Investigational Site
    New Orleans, Louisiana 70119, United States
  • GSK Investigational Site
    Slidell, Louisiana 70461, United States
  • GSK Investigational Site
    Sunset, Louisiana 70584, United States
  • GSK Investigational Site
    Boston, Massachusetts 02135, United States
  • GSK Investigational Site
    Cadillac, Michigan 49601, United States
  • GSK Investigational Site
    Minneapolis, Minnesota 55402, United States
  • GSK Investigational Site
    Jefferson City, Missouri 65109, United States
  • GSK Investigational Site
    St. Charles, Missouri 63301, United States
  • GSK Investigational Site
    St. Louis, Missouri 63122, United States
  • GSK Investigational Site
    St. Louis, Missouri 63141, United States
  • GSK Investigational Site
    Billings, Montana 59102, United States
  • GSK Investigational Site
    Missoula, Montana 59808, United States
  • GSK Investigational Site
    Las Vegas, Nevada 89104, United States
  • GSK Investigational Site
    Cherry Hill, New Jersey 08003, United States
  • GSK Investigational Site
    Bronxville, New York 10708, United States
  • GSK Investigational Site
    Cortland, New York 14850, United States
  • GSK Investigational Site
    Larchmont, New York 10538, United States
  • GSK Investigational Site
    New York, New York 10016, United States
  • GSK Investigational Site
    Chapel Hill, North Carolina 27599, United States
  • GSK Investigational Site
    Charlotte, North Carolina 28207, United States
  • GSK Investigational Site
    Elizabeth City, North Carolina 27909, United States
  • GSK Investigational Site
    High Point, North Carolina 27262, United States
  • GSK Investigational Site
    Statesville, North Carolina 28625, United States
  • GSK Investigational Site
    Chardon, Ohio 44024, United States
  • GSK Investigational Site
    Columbus, Ohio 43215, United States
  • GSK Investigational Site
    Dayton, Ohio 45406, United States
  • GSK Investigational Site
    Sylvania, Ohio 43560, United States
  • GSK Investigational Site
    Lake Oswego, Oregon 97035, United States
  • GSK Investigational Site
    Medford, Oregon 97504, United States
  • GSK Investigational Site
    Portland, Oregon 97213, United States
  • GSK Investigational Site
    Allentown, Pennsylvania 18103, United States
  • GSK Investigational Site
    Downington, Pennsylvania 19335, United States
  • GSK Investigational Site
    Elverson, Pennsylvania 19520, United States
  • GSK Investigational Site
    Erie, Pennsylvania 16508, United States
  • GSK Investigational Site
    Pittsburgh, Pennsylvania 15213, United States
  • GSK Investigational Site
    Pittsburgh, Pennsylvania 15218, United States
  • GSK Investigational Site
    Pittsburgh, Pennsylvania 15243, United States
  • GSK Investigational Site
    Swarthmore, Pennsylvania 19081, United States
  • GSK Investigational Site
    East Providence, Rhode Island 02914, United States
  • GSK Investigational Site
    Charleston, South Carolina 29406-7108, United States
  • GSK Investigational Site
    Gaffney, South Carolina 29340, United States
  • GSK Investigational Site
    Greer, South Carolina 29651, United States
  • GSK Investigational Site
    Simpsonville, South Carolina 29681, United States
  • GSK Investigational Site
    Spartanburg, South Carolina 29303, United States
  • GSK Investigational Site
    Bristol, Tennessee 37620, United States
  • GSK Investigational Site
    Chattanooga, Tennessee 37403, United States
  • GSK Investigational Site
    Johnson City, Tennessee 37601, United States
  • GSK Investigational Site
    Knoxville, Tennessee 37920, United States

Showing the first 100 of 115 sites.

08

References and documents

Individual participant data

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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00103922
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Feb 18, 2005
Start date
Nov 2004
Primary completion
Jan 2007
Completion
Jan 2007
Last update
Oct 28, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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