Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00103922
First received: February 17, 2005
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

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


Condition Intervention Phase
Emphysema
Bronchitis
Drug: cilomilast
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, 24-week, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety and Tolerability of ARIFLO® (15mg BID) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • measure of lung function and quality of life in patients with COPD

Secondary Outcome Measures:
  • exacerbations in patients with COPD

Estimated Enrollment: 600
Study Start Date: November 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: cilomilast
    Other Name: cilomilast
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103922

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35209
GSK Investigational Site
Jasper, Alabama, United States, 35501
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85006
GSK Investigational Site
Tempe, Arizona, United States, 85282
United States, California
GSK Investigational Site
Berkeley, California, United States, 94705
GSK Investigational Site
Fullerton, California, United States, 92835
GSK Investigational Site
Long Beach, California, United States, 90806
GSK Investigational Site
Long Beach, California, United States, 90822
GSK Investigational Site
Los Angeles, California, United States, 90048
GSK Investigational Site
Murrieta, California, United States, 92562
GSK Investigational Site
Rancho Mirage, California, United States, 92270
GSK Investigational Site
Riverside, California, United States, 92805
GSK Investigational Site
Sacramento, California, United States, 95823
GSK Investigational Site
San Diego, California, United States, 92120
GSK Investigational Site
San Diego, California, United States, 92103
GSK Investigational Site
San Jose, California, United States, 95117
GSK Investigational Site
Sepulveda, California, United States, 91343
GSK Investigational Site
Stockton, California, United States, 95207
GSK Investigational Site
Torrance, California, United States, 90509
GSK Investigational Site
Vista, California, United States, 92083
GSK Investigational Site
Walnut Creek, California, United States, 94598
United States, Colorado
GSK Investigational Site
Boulder, Colorado, United States, 80304
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
GSK Investigational Site
Denver, Colorado, United States, 80230
GSK Investigational Site
Englewood, Colorado, United States, 80112
GSK Investigational Site
Fort Collins, Colorado, United States, 80528
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
GSK Investigational Site
Hartford, Connecticut, United States, 06105
GSK Investigational Site
Stamford, Connecticut, United States, 06902
GSK Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Florida
GSK Investigational Site
Aventura, Florida, United States, 33180
GSK Investigational Site
Brandon, Florida, United States, 33511
GSK Investigational Site
Deland, Florida, United States, 32720
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
GSK Investigational Site
Largo, Florida, United States, 33770
GSK Investigational Site
Longwood, Florida, United States, 32779
GSK Investigational Site
Melbourne, Florida, United States, 32935
GSK Investigational Site
Panama City, Florida, United States, 32405
GSK Investigational Site
Pensacola, Florida, United States, 32504
GSK Investigational Site
Tamarac, Florida, United States, 33321
GSK Investigational Site
Tampa, Florida, United States, 33613
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
GSK Investigational Site
Decatur, Georgia, United States, 30033
United States, Idaho
GSK Investigational Site
Coeur D'Alene, Idaho, United States, 83814
United States, Illinois
GSK Investigational Site
Normal, Illinois, United States, 61761
United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47710
GSK Investigational Site
South Bend, Indiana, United States, 46617
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67207
United States, Kentucky
GSK Investigational Site
Madisonville, Kentucky, United States, 42431
United States, Louisiana
GSK Investigational Site
Lafayette, Louisiana, United States, 70503
GSK Investigational Site
New Orleans, Louisiana, United States, 70119
GSK Investigational Site
Slidell, Louisiana, United States, 70461
GSK Investigational Site
Sunset, Louisiana, United States, 70584
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02135
United States, Michigan
GSK Investigational Site
Cadillac, Michigan, United States, 49601
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
United States, Missouri
GSK Investigational Site
Jefferson City, Missouri, United States, 65109
GSK Investigational Site
St. Charles, Missouri, United States, 63301
GSK Investigational Site
St. Louis, Missouri, United States, 63141
GSK Investigational Site
St. Louis, Missouri, United States, 63122
United States, Montana
GSK Investigational Site
Billings, Montana, United States, 59102
GSK Investigational Site
Missoula, Montana, United States, 59808
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
United States, New Jersey
GSK Investigational Site
Cherry Hill, New Jersey, United States, 08003
United States, New York
GSK Investigational Site
Bronxville, New York, United States, 10708
GSK Investigational Site
Larchmont, New York, United States, 10538
GSK Investigational Site
New York, New York, United States, 10016
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
GSK Investigational Site
Elizabeth City, North Carolina, United States, 27909
GSK Investigational Site
High Point, North Carolina, United States, 27262
GSK Investigational Site
Statesville, North Carolina, United States, 28625
United States, Ohio
GSK Investigational Site
Chardon, Ohio, United States, 44024
GSK Investigational Site
Columbus, Ohio, United States, 43215
GSK Investigational Site
Dayton, Ohio, United States, 45406
GSK Investigational Site
Sylvania, Ohio, United States, 43560
United States, Oregon
GSK Investigational Site
Lake Oswego, Oregon, United States, 97035
GSK Investigational Site
Medford, Oregon, United States, 97504
GSK Investigational Site
Portland, Oregon, United States, 97213
United States, Pennsylvania
GSK Investigational Site
Allentown, Pennsylvania, United States, 18103
GSK Investigational Site
Downington, Pennsylvania, United States, 19335
GSK Investigational Site
Elverson, Pennsylvania, United States, 19520
GSK Investigational Site
Erie, Pennsylvania, United States, 16508
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15243
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15218
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
GSK Investigational Site
Swarthmore, Pennsylvania, United States, 19081
United States, Rhode Island
GSK Investigational Site
East Providence, Rhode Island, United States, 02914
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29406-7108
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
GSK Investigational Site
Greer, South Carolina, United States, 29651
GSK Investigational Site
Simpsonville, South Carolina, United States, 29681
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
GSK Investigational Site
Bristol, Tennessee, United States, 37620
GSK Investigational Site
Johnson City, Tennessee, United States, 37601
GSK Investigational Site
Knoxville, Tennessee, United States, 37920
United States, Texas
GSK Investigational Site
Corsicana, Texas, United States, 75110
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
San Antonio, Texas, United States, 78205
GSK Investigational Site
San Antonio, Texas, United States, 78217
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84102
United States, Virginia
GSK Investigational Site
Richmond, Virginia, United States, 23225
GSK Investigational Site
Richmond, Virginia, United States, 23229
United States, Washington
GSK Investigational Site
Bellingham, Washington, United States, 98225
GSK Investigational Site
Spokane, Washington, United States, 99207
GSK Investigational Site
Spokane, Washington, United States, 99204
GSK Investigational Site
Tacoma, Washington, United States, 98405
United States, West Virginia
GSK Investigational Site
Morgantown, West Virginia, United States, 26505
United States, Wisconsin
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53209-0996
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00103922     History of Changes
Other Study ID Numbers: CIL103657
Study First Received: February 17, 2005
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
smokers cough

Additional relevant MeSH terms:
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cilomilast
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 4 Inhibitors
Phosphodiesterase Inhibitors

ClinicalTrials.gov processed this record on November 23, 2014