This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by the Food and Drug Administration (FDA) for use in patients with COPD.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Fluticasone Propionate/Salmeterol  Drug: Salmeterol	Phase IV

Further Study Details: 

Primary Outcomes: Rate of moderate/severe exacerbations over a 52 week treatment period
Secondary Outcomes: The time until the first moderate/severe exacerbation; The annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year
Expected Total Enrollment:  740

Ages Eligible for Study:  40 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Have a diagnosis of COPD.

Exclusion Criteria:

• Have a diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD.

Other inclusion and exclusion criteria will be evaluated at the first study visit.

Please refer to this study by ClinicalTrials.gov identifier  NCT00115492

Alabama
      Allan Seibert, Mobile,  Alabama,  36608,  United States; Recruiting
Arizona
      Amy Silverthorn, Phoenix,  Arizona,  85013,  United States; Recruiting
California
      Jeffrey Newman, Vista,  California,  92084,  United States; Not yet recruiting
      James Pearle, Fullerton,  California,  92835,  United States; Recruiting
      James McFeely, Berkeley,  California,  94705,  United States; Recruiting
Colorado
      James Hoyt, Ft. Collins,  Colorado,  80528,  United States; Recruiting
Florida
      Gary Richmond, Ft. Lauderdale,  Florida,  33316,  United States; Recruiting
      Peter Cowen, Atlantis,  Florida,  33462,  United States; Recruiting
      Brian Salisbury, Largo,  Florida,  33773,  United States; Recruiting
      Todd Horiuchi, Sarasota,  Florida,  34239,  United States; Recruiting
Georgia
      Bram Wieskopf, Woodstock,  Georgia,  30189,  United States; Recruiting
Illinois
      Joseph Henkle, Springfield,  Illinois,  62702,  United States; Recruiting
Indiana
      Pinkus Goldberg, Indianapolis,  Indiana,  46208,  United States; Recruiting
      George Mark, Elkhart,  Indiana,  46514,  United States; Recruiting
      Steven Elliott, Evansville,  Indiana,  47714,  United States; Recruiting
Kansas
      James Bradley, Olathe,  Kansas,  66061,  United States; Recruiting
Louisiana
      Ben deBoisblanc, New Orleans,  Louisiana,  70112,  United States; Recruiting
      John Sibille, Sunset,  Louisiana,  70584,  United States; Recruiting
Massachusetts
      Bartoleme Celli, Boston,  Massachusetts,  02145,  United States; Recruiting
Michigan
      Robert Piasecki, St. Joseph,  Michigan,  49085,  United States; Recruiting
Missouri
      Neil Ettinger, Chesterfield,  Missouri,  63017,  United States; Recruiting
      Mario Castro, St. Louis,  Missouri,  63110,  United States; Recruiting
Nebraska
      Guillermo Huerta, Omaha,  Nebraska,  68124,  United States; Recruiting
      Dan Schuller, Omaha,  Nebraska,  68131,  United States; Recruiting
New Jersey
      John Jayne, Absecon,  New Jersey,  08201,  United States; Recruiting
New York
      Stuart Garay, New York,  New York,  10016,  United States; Recruiting
      Christopher Smith, Cortland,  New York,  13045,  United States; Recruiting
North Carolina
      Eugene Bleeker, Winston Salem,  North Carolina,  27157,  United States; Not yet recruiting
      Johnathan Plitman, High Point,  North Carolina,  27262,  United States; Recruiting
      James Donohue, Chapel Hill,  North Carolina,  27599,  United States; Recruiting
      Jonathan Flescher, Raleigh,  North Carolina,  27612,  United States; Recruiting
Ohio
      Anthony, Chardon,  Ohio,  44024,  United States; Recruiting
      Dennis McCluskey, Mogadore,  Ohio,  44260,  United States; Recruiting
      John Given, Canton,  Ohio,  44718,  United States; Recruiting
Oregon
      James Baker, Lake Oswego,  Oregon,  97035,  United States; Recruiting
Pennsylvania
      Kenneth Chinsky, Erie,  Pennsylvania,  16506,  United States; Recruiting
      Timothy Craig, Hershey,  Pennsylvania,  17033,  United States; Recruiting
South Carolina
      Greg Feldman, Spartanburg,  South Carolina,  29303,  United States; Recruiting
      Philip Snell, Greer,  South Carolina,  29651,  United States; Recruiting
      Krishna Pudi, Simpsonville,  South Carolina,  29681,  United States; Recruiting
Tennessee
      Peter Platzer, Kingsport,  Tennessee,  37660,  United States; Recruiting
Texas
      Carlos Girod, Dallas,  Texas,  75390,  United States; Not yet recruiting
      Benjamin Interiano, Houston,  Texas,  77074,  United States; Recruiting
      Frank Hampel, New Braunfels,  Texas,  78130,  United States; Recruiting
      Rod Elliott-Mullens, Seguin,  Texas,  78155,  United States; Recruiting
      Michael Natalino, San Antonio,  Texas,  78217,  United States; Recruiting
Virginia
      Glen Giessel, Richmond,  Virginia,  23225,  United States; Recruiting
Washington
      Paul Sandstrom, Kirkland,  Washington,  98034,  United States; Recruiting
Wisconsin
      Richard Harbecke, Milwaukee,  Wisconsin,  53209,  United States; Recruiting

Study chairs or principal investigators

GSK Clinical Trials Call Center,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  SCO100250
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 22, 2005
ClinicalTrials.gov Identifier:  NCT00115492
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05