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ADVAIR® DISKUS® Inhaler (Fluticasone Propionate/Salmeterol) Versus SEREVENT® DISKUS® Inhaler (Salmeterol) For The Treatment Of Chronic Obstructive Pulmonary Disease Exacerbations. ADVAIR® DISKUS® Inhaler and SEREVENT® DISKUS® Inhaler Are Trademarks of the GSK Group of Companies.

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00144911
Collaborator
(none)
740
Enrollment
97
Locations
1
Arm
26
Duration (Months)
7.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
740 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of Fluticasone Propionate/Salmeterol DISKUS® Inhaler Combination Product 250/50mcg Twice Daily With Salmeterol DISKUS® Inhaler 50mcg Twice Daily on the Annual Rate of Moderate/Severe Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Study Start Date :
Oct 1, 2004
Actual Primary Completion Date :
Dec 1, 2006
Actual Study Completion Date :
Dec 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Drug: Salmeterol

Drug: Fluticasone Propionate/Salmeterol Combination Product
Other Names:
  • Salmeterol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of moderate/severe exacerbations over a 52 week treatment period. []

    Secondary Outcome Measures

    1. The time until the first moderate/severe exacerbation, the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year. []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of COPD (chronic obstructive pulmonary disease).

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GSK Investigational Site Birmingham Alabama United States 35209
    2 GSK Investigational Site Birmingham Alabama United States 35294-0012
    3 GSK Investigational Site Jasper Alabama United States 35501
    4 GSK Investigational Site Glendale Arizona United States 85306
    5 GSK Investigational Site Phoenix Arizona United States 85013
    6 GSK Investigational Site Scottsdale Arizona United States 85258
    7 GSK Investigational Site Little Rock Arkansas United States 72205
    8 GSK Investigational Site Corona California United States 92879
    9 GSK Investigational Site Los Angeles California United States 90095-1752
    10 GSK Investigational Site Palmdale California United States 93551
    11 GSK Investigational Site Paramount California United States 90723
    12 GSK Investigational Site Rancho Mirage California United States 92270
    13 GSK Investigational Site Riverside California United States 92506
    14 GSK Investigational Site Sacramento California United States 95825-5480
    15 GSK Investigational Site San Diego California United States 92120
    16 GSK Investigational Site Sepulveda California United States 91343
    17 GSK Investigational Site Stockton California United States 95207
    18 GSK Investigational Site Colorado Springs Colorado United States 80907
    19 GSK Investigational Site Denver Colorado United States 80204
    20 GSK Investigational Site Denver Colorado United States 80206
    21 GSK Investigational Site Englewood Colorado United States 80113
    22 GSK Investigational Site Wheat Ridge Colorado United States 80033
    23 GSK Investigational Site Deland Florida United States 32720
    24 GSK Investigational Site Jacksonville Florida United States 32205
    25 GSK Investigational Site Largo Florida United States 33770
    26 GSK Investigational Site North Miami Beach Florida United States 33179
    27 GSK Investigational Site Pensacola Florida United States 32504
    28 GSK Investigational Site Tampa Florida United States 33613
    29 GSK Investigational Site Coeur D'Alene Idaho United States 83814
    30 GSK Investigational Site Champaign Illinois United States 61821
    31 GSK Investigational Site Chicago Illinois United States 60612
    32 GSK Investigational Site Peoria Illinois United States 61602
    33 GSK Investigational Site Evansville Indiana United States 47710
    34 GSK Investigational Site South Bend Indiana United States 46617
    35 GSK Investigational Site Des Moines Iowa United States 50309
    36 GSK Investigational Site Lafayette Louisiana United States 70503
    37 GSK Investigational Site Slidell Louisiana United States 70458
    38 GSK Investigational Site Auburn Maine United States 04210
    39 GSK Investigational Site Boston Massachusetts United States 02118
    40 GSK Investigational Site Worcester Massachusetts United States 01608
    41 GSK Investigational Site Kalamazoo Michigan United States 49009
    42 GSK Investigational Site Minneapolis Minnesota United States 55407
    43 GSK Investigational Site Rochester Minnesota United States 55905
    44 GSK Investigational Site Kansas City Missouri United States 64108
    45 GSK Investigational Site St. Charles Missouri United States 63301
    46 GSK Investigational Site St. Louis Missouri United States 63122
    47 GSK Investigational Site Omaha Nebraska United States 68105
    48 GSK Investigational Site Omaha Nebraska United States 68134
    49 GSK Investigational Site Cherry Hill New Jersey United States 08003
    50 GSK Investigational Site Summit New Jersey United States 07091
    51 GSK Investigational Site Albuquerque New Mexico United States 87108
    52 GSK Investigational Site Larchmont New York United States 10538
    53 GSK Investigational Site Lewistown New York United States 14092
    54 GSK Investigational Site Elizabeth City North Carolina United States 27909
    55 GSK Investigational Site Raleigh North Carolina United States 27607
    56 GSK Investigational Site Statesville North Carolina United States 28625
    57 GSK Investigational Site Cincinnati Ohio United States 45219
    58 GSK Investigational Site Cincinnati Ohio United States 45231
    59 GSK Investigational Site Cleveland Ohio United States 44109
    60 GSK Investigational Site Columbus Ohio United States 43215
    61 GSK Investigational Site Toledo Ohio United States 43614-5809
    62 GSK Investigational Site Tulsa Oklahoma United States 74135
    63 GSK Investigational Site Eugene Oregon United States 97401
    64 GSK Investigational Site Medford Oregon United States 97504
    65 GSK Investigational Site Portland Oregon United States 97213
    66 GSK Investigational Site Philadelphia Pennsylvania United States 19140
    67 GSK Investigational Site Pittsburgh Pennsylvania United States 15243
    68 GSK Investigational Site Cumberland Rhode Island United States 02864
    69 GSK Investigational Site Providence Rhode Island United States 02906
    70 GSK Investigational Site Charleston South Carolina United States 29406-7108
    71 GSK Investigational Site Greer South Carolina United States 29651
    72 GSK Investigational Site Simpsonville South Carolina United States 29681
    73 GSK Investigational Site Spartanburg South Carolina United States 29303
    74 GSK Investigational Site Bristol Tennessee United States 37620
    75 GSK Investigational Site Johnson City Tennessee United States 37601
    76 GSK Investigational Site Corsicana Texas United States 75110
    77 GSK Investigational Site Fort Worth Texas United States 76104
    78 GSK Investigational Site Houston Texas United States 77030
    79 GSK Investigational Site San Antonio Texas United States 78229
    80 GSK Investigational Site Abingdon Virginia United States 24210
    81 GSK Investigational Site Charlottesville Virginia United States 22908
    82 GSK Investigational Site Newport News Virginia United States 23606
    83 GSK Investigational Site Gig Harbor Washington United States 98335
    84 GSK Investigational Site Spokane Washington United States 99202
    85 GSK Investigational Site Morgantown West Virginia United States 26505
    86 GSK Investigational Site Calgary Alberta Canada T2N 4N1
    87 GSK Investigational Site Winnipeg Manitoba Canada R2K 3S8
    88 GSK Investigational Site Grimsby Ontario Canada L3M 1P3
    89 GSK Investigational Site Toronto Ontario Canada M5G 1N8
    90 GSK Investigational Site Cowansville Quebec Canada J2K 2X9
    91 GSK Investigational Site La Malbaie Quebec Canada G5A 1W7
    92 GSK Investigational Site Montreal Quebec Canada H3T 1Y6
    93 GSK Investigational Site Saint Leonard Quebec Canada H1S 3A9
    94 GSK Investigational Site Sainte Jerome Quebec Canada J7Z 5T3
    95 GSK Investigational Site Sainte-Foy Quebec Canada G1V 4G5
    96 GSK Investigational Site Sherbrooke Quebec Canada J1H 4J6
    97 GSK Investigational Site Sorel Quebec Canada J3P 1N5

    Sponsors and Collaborators

    • GlaxoSmithKline

    Investigators

    • Study Director: GSK Clinical Trials, GlaxoSmithKline

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT00144911
    Other Study ID Numbers:
    • SCO40043
    First Posted:
    Sep 5, 2005
    Last Update Posted:
    Oct 28, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by GlaxoSmithKline
    exacerbations
    breathing
    chronic obstructive pulmonary disease
    Additional relevant MeSH terms:
    Lung Diseases
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive
    Fluticasone
    Xhance
    Salmeterol Xinafoate

    Study Results

    No Results Posted as of Oct 28, 2016