Last updated: 11/04/2018 11:40:02

Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations

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GSK study ID
SCO100250
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Clinicaltrials.gov ID
NCT00115492
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of 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
Trial description: 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 FDA for use in patients with COPD.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Fluticasone Propionate/Salmeterol Combination Product
  • Drug: Salmeterol
    • Enrollment:
    797
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    December 2004 to June 2007
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    40 years - 0 Not applicable
    Accepts healthy volunteers
    No
    • Diagnosis of COPD.
    • Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
    • Diagnosis of asthma.
    • Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Diagnosis of COPD.
    • Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
    • History of at 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:
    • 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.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Kirkland, Washington, United States, 98034
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New York, New York, United States, 10016
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Springfield, Illinois, United States, 62702
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Riverside, California, United States, 92506
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Saint John, New Brunswick, Canada, E2M 3W5
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Marcos, Texas, United States, 78666
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Billings, Montana, United States, 59102
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bayshore, New York, United States, 11706
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fort Lauderdale, Florida, United States, 33316
    Status
    Study Complete
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    Location
    GSK Investigational Site
    South Bend, Indiana, United States, 46617
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Elkhart, Indiana, United States, 46154
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Minneapolis, Minnesota, United States, 55407
    Status
    Study Complete
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    Location
    GSK Investigational Site
    La Crosse, Wisconsin, United States, 54601
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berkeley, California, United States, 94705
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23225
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Grimsby, Ontario, Canada, L3M 1P3
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chandler, Québec, Canada, G0C 1K0
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63110
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27612
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bonaventure, Québec, Canada, G0C 1E0
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Trois Rivieres, Québec, Canada, G8T 7A1
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85013
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15243
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Albany, New York, United States, 12205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lafayette, Louisiana, United States, 70503
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlotte, North Carolina, United States, 28207
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30342
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78217
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Milwaukee, Wisconsin, United States, 53209
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75390-9016
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Glendale, Arizona, United States, 85306
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46208
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Winnipeg, Manitoba, Canada, R2K 3S8
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bay Roberts, Newfoundland and Labrador, Canada, A0G 1G0
    Status
    Study Complete
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    Location
    GSK Investigational Site
    McKeesport, Pennsylvania, United States, 15132
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68131
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02135
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Abingdon, Virginia, United States, 24210
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Madisonville, Kentucky, United States, 42431
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Morgantown, West Virginia, United States, 26505
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mogadore, Ohio, United States, 44260
    Status
    Study Complete
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    Location
    GSK Investigational Site
    East Providence, Rhode Island, United States, 02914
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ithaca, New York, United States, 14850
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Evansville, Indiana, United States, 47710
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Clear Water, Florida, United States, 33756
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bristol, Tennessee, United States, 37620
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Simpsonville, South Carolina, United States, 29681
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Auburn, Maine, United States, 04210
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92123
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Butte, Montana, United States, 59701
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Atlantis, Florida, United States, 33462
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Absecon, New Jersey, United States, 08201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68124
    Status
    Study Complete
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    Location
    GSK Investigational Site
    London, Ontario, Canada, N6C 4Y7
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Saint Leonard, Québec, Canada, H1S 3A9
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Spartanburg, South Carolina, United States, 29303
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Shreveport, Louisiana, United States, 71103
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Elizabeth City, North Carolina, United States, 27909
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tamarac, Florida, United States, 33321
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sacramento, California, United States, 95825
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hershey, Pennsylvania, United States, 17033
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Olathe, Kansas, United States, 66061
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bellingham, Washington, United States, 98226
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Charles, Missouri, United States, 63301
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sunset, Louisiana, United States, 70584
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New Orleans, Louisiana, United States, 70112
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Vancouver, British Columbia, Canada, V5Z 3J5
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lake Oswego, Oregon, United States, 97035
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Larchmont, New York, United States, 10538
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mobile, Alabama, United States, 36608
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chattanooga, Tennessee, United States, 37403
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Greer, South Carolina, United States, 29651
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chardon, Ohio, United States, 44024
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Deland, Florida, United States, 32720
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gatineau, Québec, Canada, J8Y 6S8
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Holyrood, Newfoundland and Labrador, Canada, A0A 2R0
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlesbourg, Québec, Canada, G1G 4A2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kingsport, Tennessee, United States, 37660
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New Braunfels, Texas, United States, 78130
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Woodstock, Georgia, United States, 30189
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77074
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fort Collins, Colorado, United States, 80528
    Status
    Study Complete
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    Location
    GSK Investigational Site
    High Point, North Carolina, United States, 27262
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Iowa City, Iowa, United States, 52242
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Spokane, Washington, United States, 99204
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pensacola, Florida, United States, 32504
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Evansville, Indiana, United States, 47714
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gig Harbor, Washington, United States, 98335
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chapel Hill, North Carolina, United States, 27599
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Vista, California, United States, 92084
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Thunder Bay, Ontario, Canada, P7A 4V7
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Winston-Salem, North Carolina, United States, 27157
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sherbrooke, Québec, Canada, J1H 1Z1
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newport News, Virginia, United States, 23606
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chesterfield, Missouri, United States, 63017
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jefferson City, Missouri, United States, 65101
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lynchburg, Virginia, United States, 24501
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jasper, Alabama, United States, 35501
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Stamford, Connecticut, United States, 06902
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Joseph, Michigan, United States, 49085
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Providence, Rhode Island, United States, 2909
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Erie, Pennsylvania, United States, 16508
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15025
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gaffney, South Carolina, United States, 29340
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Canton, Ohio, United States, 44718
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Johnson City, Tennessee, United States, 37601
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fullerton, California, United States, 92835
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sarasota, Florida, United States, 34239
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-14-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

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