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Advair® DISKUS® (Fluticasone Propionate/Salmeterol) Versus Serevent® DISKUS® (Salmeterol) For The Treatment Of Chronic Obstructive Pulmonary Disease Exacerbations - Article


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Clinical Trial: Advair® DISKUS® (Fluticasone Propionate/Salmeterol) Versus Serevent® DISKUS® (Salmeterol) For The Treatment Of Chronic Obstructive Pulmonary Disease Exacerbations

This study is currently recruiting patients.
Verified by GlaxoSmithKline September 2005

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00144911

Purpose

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 FDA for use in patients with COPD.
Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
  Drug: Salmeterol
 Drug: Fluticasone Propionate/Salmeterol Combination Product
 Phase IV

MedlinePlus related topics:  COPD (Chronic Obstructive Pulmonary Disease)

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Official Title: A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of the Fluticasone Propionate/Salmeterol DISKUS Combination Product 250/50mcg BID with Salmeterol DISKUS 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

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

Study start: October 2004

Eligibility

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

Inclusion Criteria:

  • Diagnosis of COPD.
  • Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
  • History of a least 1 COPD exacerbation in the 12 months prior to screening.
  • Forced expiratory volume in one second (FEV1) of less than or equal to 50% of predicted normal.

Exclusion Criteria:

  • Current diagnosis of asthma.
  • Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).
  • Concurrent use of long-acting beta-agonists, long-acting anticholinergics, inhaled and oral corticosteroids, theophylline, investigational medications, ritonavir, and anti-leukotrienes.
  • Lung resection surgery within 1 year of screening.
  • Abnormal and clinically significant ECG findings at screening.
  • Other inclusion and exclusion criteria will be evaluated at the first study visit.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00144911


Alabama
      GSK Clinical Trials Call Center, Birmingham,  Alabama,  35294,  United States; Recruiting
William Bailey  877-379-3718 

      GSK Clinical Trials Call Center, Birmingham,  Alabama,  35209,  United States; Recruiting
Gustavo DuBois  877-379-3718 

      GSK Clinical Trials Call Center, Jasper,  Alabama,  35501,  United States; Recruiting
Jan Westerman  877-379-3718 

Arizona
      GSK Clinical Trials Call Center, Pheonix,  Arizona,  85006,  United States; Recruiting
Robert Kearl  877-379-3718 

      GSK Clinical Trials Call Center, Glendale,  Arizona,  85306,  United States; Recruiting
Mark Gotfried  877-379-3718 

      GSK Clinical Trials Call Center, Scottsdale,  Arizona,  85258,  United States; Recruiting
Judson Tillinghast  877-379-3718 

Arkansas
      GSK Clinical Trials Call Center, Little Rock,  Arkansas,  72205,  United States; Recruiting
Paula Anderson  877-379-3718 

California
      GSK Clinical Trials Call Center, Stockton,  California,  95207,  United States; Recruiting
George Bensch  877-379-3718 

      GSK Clinical Trials Call Center, Palmdale,  California,  93551,  United States; Recruiting
Ricardo Tan  877-379-3718 

      GSK Clinical Trials Call Center, Corona,  California,  92879,  United States; Recruiting
Shams Iqbal  877-379-3718 

      GSK Clinical Trials Call Center, Los Angeles,  California,  90095,  United States; Recruiting
Eric Kleerup  877-379-3718 

      GSK Clinical Trials Call Center, Sepulveda,  California,  91343,  United States; Recruiting
Michael Littner  877-379-3718 

      GSK Clinical Trials Call Center, Rancho Mirage,  California,  92270,  United States; Recruiting
Gary Greenwald  877-379-3718 

      GSK Clinical Trials Call Center, San Diego,  California,  92120,  United States; Recruiting
Shari Brazinsky  877-379-3718 

      GSK Clinical Trials Call Center, Paramount,  California,  90723,  United States; Recruiting
Eleuterio Delfin  877-379-3718 

      GSK Clinical Trials Call Center, Sacramento,  California,  95825,  United States; Recruiting
Daniel Ikeda  877-379-3718 

      GSK Clinical Trials Call Center, Riverside,  California,  92506,  United States; No longer recruiting

Colorado
      GSK Clinical Trials Call Center, Pueblo,  Colorado,  81001,  United States; Recruiting
Robert Nathan  877-379-3718 

      GSK Clinical Trials Call Center, Englewood,  Colorado,  80120,  United States; Recruiting
James Fenton  877-379-3718 

      GSK Clinical Trials Call Center, Wheat Ridge,  Colorado,  80033,  United States; Recruiting
Robert Lapidus  877-379-3718 

      GSK Clinical Trials Call Center, Denver,  Colorado,  80206,  United States; Recruiting
Barry Make  877-379-3718 

      GSK Clinical Trials Call Center, Denver,  Colorado,  80204,  United States; Recruiting
Matthew Dickinson  877-379-3718 

Florida
      GSK Clinical Trials Call Center, Largo,  Florida,  33770,  United States; Recruiting
Francis Averil  877-379-3718 

      GSK Clinical Trials Call Center, Tampa,  Florida,  33613,  United States; Recruiting
Richard Lockey  877-379-3718 

      GSK Clinical Trials Call Center, Pensacola,  Florida,  32504,  United States; Recruiting
Stephen Kimura  877-379-3718 

      GSK Clinical Trials Call Center, Deland,  Florida,  32720,  United States; Recruiting
Albert Razzetti  877-379-3718 

      GSK Clinical Trials Call Center, Jacksonville,  Florida,  32205,  United States; Recruiting
Erich Schramm  877-379-3718 

Idaho
      GSK Clinical Trials Call Center, Coeur D Alene,  Idaho,  83814,  United States; Recruiting
Henry Covelli  877-379-3718 

Illinois
      GSK Clinical Trials Call Center, Chicago,  Illinois,  60612,  United States; Recruiting
Robert Balk  877-379-3718 

      GSK Clinical Trials Call Center, Peoria,  Illinois,  61602,  United States; Recruiting
Daniel Brune  877-379-3718 

      GSK Clinical Trials Call Center, Champaign,  Illinois,  61821,  United States; Recruiting
Kathleen Collins  877-379-3718 

Indiana
      GSK Clinical Trials Call Center, South Bend,  Indiana,  46617,  United States; Recruiting
James Harris  877-379-3718 

Iowa
      GSK Clinical Trials Call Center, Des Moines,  Iowa,  50309,  United States; Recruiting
Randall Hanson  877-379-3718 

Louisiana
      GSK Clinical Trials Call Center, Lafayette,  Louisiana,  70503,  United States; Recruiting
Richard Fei  877-379-3718 

      GSK Clinical Trials Call Center, Slidell,  Louisiana,  70458,  United States; Recruiting
Adesh Jain  877-379-3718 

Maine
      GSK Clinical Trials Call Center, Portland,  Maine,  04102,  United States; Recruiting
Robert McArdle  877-379-3718 

      GSK Clinical Trials Call Center, Ashburn,  Maine,  04210,  United States; Recruiting
Richard Kahn  877-379-3718 

Maryland
      GSK Clinical Trials Call Center, Baltimore,  Maryland,  21201,  United States; Not yet recruiting
Pamela Amelung  877-379-3718 

      GSK Clinical Trials Call Center, Baltimore,  Maryland,  21224,  United States; Recruiting
Robert Wise  877-379-3718 

Massachusetts
      GSK Clinical Trials Call Center, Worcester,  Massachusetts,  01605,  United States; Recruiting
Daniel Steigman  877-379-3718 

      GSK Clinical Trials Call Center, Boston,  Massachusetts,  02118,  United States; Recruiting
Helen Hollinsworth  877-379-3718 

Michigan
      GSK Clinical Trials Call Center, Kalamazoo,  Michigan,  49009,  United States; Recruiting
Gary Ruoff  877-379-3718 

Minnesota
      GSK Clinical Trials Call Center, Minneapolis,  Minnesota,  55407,  United States; Recruiting
Mitchell Kaye  877-379-3718 

      GSK Clinical Trials Call Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Paul Scanlon  877-379-3718 

Missouri
      GSK Clinical Trials Call Center, St. Louis,  Missouri,  63122,  United States; Recruiting
Thomas Hyers  877-379-3718 

      GSK Clinical Trials Call Center, Kansas City,  Missouri,  64108,  United States; Recruiting
Gary Salzman  877-379-3718 

      GSK Clinical Trials Call Center, St. Charles,  Missouri,  63301,  United States; Recruiting
Thomas Siler  877-379-3718 

Nebraska
      GSK Clinical Trials Call Center, Omaha,  Nebraska,  68134,  United States; Recruiting
Mark Shirley  877-379-3718 

      GSK Clinical Trials Call Center, Omaha,  Nebraska,  68105,  United States; Recruiting
Naresh Dewan  877-379-3718 

New Jersey
      GSK Clinical Trials Call Center, Cherry Hill,  New Jersey,  08003,  United States; Recruiting
Irwin Spirn  877-379-3718 

      GSK Clinical Trials Call Center, Springfield,  New Jersey,  07081,  United States; Recruiting
Robert Sussman  877-379-3718 

New Mexico
      GSK Clinical Trials Call Center, Albuquerque,  New Mexico,  87108,  United States; Recruiting
Sheryl Mangunson  877-379-3718 

New York
      GSK Clinical Trials Call Center, Larchmont,  New York,  10538,  United States; Recruiting
Michael Mandel  877-379-3718 

      GSK Clinical Trials Call Center, Lewiston,  New York,  14092,  United States; Recruiting
Lee Ruotsi  877-379-3718 

North Carolina
      GSK Clinical Trials Call Center, Statesville,  North Carolina,  28625,  United States; Recruiting
Joseph Moran  877-379-3718 

      GSK Clinical Trials Call Center, Elizabeth City,  North Carolina,  27909,  United States; Recruiting
Albrecht Heyder  877-379-3718 

      GSK Clinical Trials Call Center, Raleigh,  North Carolina,  27607,  United States; Recruiting
Craig LaForce  877-379-3718 

Ohio
      GSK Clinical Trials Call Center, Cincinnati,  Ohio,  45231,  United States; Recruiting
David Bernstein  877-379-3718 

      GSK Clinical Trials Call Center, Columbus,  Ohio,  43215,  United States; Recruiting
Charles Kistler  877-379-3718 

      GSK Clinical Trials Call Center, Cleveland,  Ohio,  44109,  United States; Recruiting
Edward McFadden  877-379-3718 

      GSK Clinical Trials Call Center, Toledo,  Ohio,  43614,  United States; Recruiting
Jeffrey Hammersley  877-379-3718 

      GSK Clinical Trials Call Center, Cincinnati,  Ohio,  45219,  United States; Recruiting
Michael Safdi  877-379-3718 

Oklahoma
      GSK Clinical Trials Call Center, Tulsa,  Oklahoma,  74135,  United States; Recruiting
Joseph Schelbar  877-379-3718 

Oregon
      GSK Clinical Trials Call Center, Portland,  Oregon,  97213,  United States; Recruiting
Michael Noonan  877-379-3718 

      GSK Clinical Trials Call Center, Eugene,  Oregon,  97401,  United States; Recruiting
Kraig Jacobson  877-379-3718 

      GSK Clinical Trials Call Center, Medford,  Oregon,  97504,  United States; Recruiting
Edward Kerwin  877-379-3718 

Pennsylvania
      GSK Clinical Trials Call Center, Pittsburgh,  Pennsylvania,  15243,  United States; Recruiting
Sephen Basheda  877-379-3718 

      GSK Clinical Trials Call Center, Philadelphia,  Pennsylvania,  19140,  United States; Recruiting
Gerard Criner  877-379-3718 

Rhode Island
      GSK Clinical Trials Call Center, Providence,  Rhode Island,  02906,  United States; Recruiting
Robert Settipane  877-379-3718 

      GSK Clinical Trials Call Center, Woonsocket,  Rhode Island,  02895,  United States; Recruiting
Christopher Superczynski  877-379-3718 

South Carolina
      GSK Clinical Trials Call Center, Spartanburg,  South Carolina,  29307,  United States; Recruiting
Charles Fogarty  877-379-3718 

      GSK Clinical Trials Call Center, Simpsonville,  South Carolina,  29681,  United States; Recruiting
Robert Broker  877-379-3718 

      GSK Clinical Trials Call Center, Greer,  South Carolina,  19140,  United States; Recruiting
Ronald DeGarmo  877-379-3718 

      GSK Clinical Trials Call Center, Charleston,  South Carolina,  29403,  United States; Recruiting
David Handshoe  877-379-3718 

Tennessee
      GSK Clinical Trials Call Center, Evansville,  Tennessee,  47710,  United States; Recruiting
James Gutmann  877-379-3718 

      GSK Clinical Trials Call Center, Bristol,  Tennessee,  37620,  United States; Recruiting
James Shrenker  877-379-3718 

Texas
      GSK Clinical Trials Call Center, Fort Worth,  Texas,  76104,  United States; Recruiting
John Burk  877-379-3718 

      GSK Clinical Trials Call Center, Houston,  Texas,  77030,  United States; Recruiting
Nicola Hanania  877-379-3718 

      GSK Clinical Trials Call Center, San Antonio,  Texas,  78238,  United States; Recruiting
Patrick Peters  877-379-3718 

      GSK Clinical Trials Call Center, Corsicana,  Texas,  75110,  United States; Recruiting
John Updegrove  877-379-3718 

Virginia
      GSK Clinical Trials Call Center, Abingdon,  Virginia,  24210,  United States; Recruiting
Emory Robinette  877-379-3718 

      GSK Clinical Trials Call Center, Newport News,  Virginia,  23606,  United States; Recruiting
Chester Fisher  877-379-3718 

      GSK Clinical Trials Call Center, Charlottesville,  Virginia,  22908,  United States; Recruiting
Steven Koenig  877-379-3718 

Washington
      GSK Clinical Trials Call Center, Spokane,  Washington,  99204,  United States; Recruiting
Richard Gower  877-379-3718 

      GSK Clinical Trials Call Center, Gig Harbor,  Washington,  98335,  United States; Recruiting
Raheela Sadiq  877-379-3718 

West Virginia
      GSK Clinical Trials Call Center, Morgantown,  West Virginia,  26505,  United States; Recruiting
Roger Abrahams  877-379-3718 

Turkey, TN
      GSK Clinical Trials Call Center, Johnson City,  TN,  37601,  Turkey; Recruiting
Wayne Gilbert  1-877-379-3718 

Study chairs or principal investigators

GSK Clinical Trials, MD,  Study Director,  GlaxoSmithKline   

More Information

Study ID Numbers:  SCO40043
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00144911
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06


Source: ClinicalTrials.gov
Cache Date: September 7, 2005

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