Last updated: 11/04/2018 05:56:53

Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease)

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GSK study ID
CIL103657
See study documents
Clinicaltrials.gov ID
NCT00103922
See results summary
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, 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)
Trial description: This study was designed to determine if the investigational drug is effective and safe in individuals with COPD (chronic pulmonary disease)
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Mean change from Baseline (BL) over 24 Wks in trough pre-bronchodilator Forced expiratory volume in 1 second (FEV1)

Timeframe: BL (Wk 0) and Wk 24

Mean change from BL over 24 Wks in total score of the St. George’s Respiratory Questionnaire (SGRQ)

Timeframe: BL (Wk 0) and Wk 24

Secondary outcomes:

Percentage of participants with Level 2 or Level 3 exacerbation-free survival at Week 24

Timeframe: Week 24

Mean change from BL in clinic trough Forced volume capacity (FVC)

Timeframe: BL (Wk 0) and endpoint assessment (upto Wk 24)

Interventions:
  • Drug: cilomilast
  • Drug: Placebo
    • Enrollment:
    612
    Primary completion date:
    2007-16-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    cilomilast
    Collaborators
    Not applicable
    Study date(s)
    November 2004 to January 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • Diagnosis of COPD and a history of cigarette smoking.
    • Significant heart or lung disease not associated with COPD.
    • Significant stomach or intestinal disease.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Wheat Ridge, Colorado, United States, 80033
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02135
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Aventura, Florida, United States, 33180
    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
    Tamarac, Florida, United States, 33321
    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
    Panama City, Florida, United States, 32405
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charleston, South Carolina, United States, 29406-7108
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Normal, Illinois, United States, 61761
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Murrieta, California, United States, 92562
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Allentown, Pennsylvania, United States, 18103
    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
    Dayton, Ohio, United States, 45406
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tempe, Arizona, United States, 85282
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15218
    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
    Madisonville, Kentucky, United States, 42431
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Erie, Pennsylvania, United States, 16508
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89104
    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
    Billings, Montana, United States, 59102
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cadillac, Michigan, United States, 49601
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Statesville, North Carolina, United States, 28625
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Medford, Oregon, United States, 97504
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Palm Beach, Florida, United States, 33409
    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
    Chattanooga, Tennessee, United States, 37403
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Coeur D'Alene, Idaho, United States, 83814
    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
    Jasper, Alabama, United States, 35501
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Vista, California, United States, 92083
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cherry Hill, New Jersey, United States, 08003
    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
    Evansville, Indiana, United States, 47710
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Colorado Springs, Colorado, United States, 80907
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sacramento, California, United States, 95823
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Milwaukee, Wisconsin, United States, 53209-0996
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bronxville, New York, United States, 10708
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boulder, Colorado, United States, 80304
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jefferson City, Missouri, United States, 65109
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Riverside, California, United States, 92805
    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
    Simpsonville, South Carolina, United States, 29681
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Torrance, California, United States, 90509
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hartford, Connecticut, United States, 06105
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75246
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Walnut Creek, California, United States, 94598
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Jose, California, United States, 95117
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Englewood, Colorado, United States, 80112
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Downington, Pennsylvania, United States, 19335
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Salt Lake City, Utah, United States, 84102
    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
    Bellingham, Washington, United States, 98225
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cortland, New York, United States, 14850
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Longwood, Florida, United States, 32779
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33613
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97213
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35209
    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
    San Diego, California, United States, 92103
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85006
    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
    Largo, Florida, United States, 33770
    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
    Corsicana, Texas, United States, 75110
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Long Beach, California, United States, 90822
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Knoxville, Tennessee, United States, 37920
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23229
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sylvania, Ohio, United States, 43560
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63141
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Decatur, Georgia, United States, 30033
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tacoma, Washington, United States, 98405
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90048
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Swarthmore, Pennsylvania, United States, 19081
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Missoula, Montana, United States, 59808
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New Orleans, Louisiana, United States, 70119
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Denver, Colorado, United States, 80230
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Elverson, Pennsylvania, United States, 19520
    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
    Fort Collins, Colorado, United States, 80528
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Long Beach, California, United States, 90806
    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
    Lafayette, Louisiana, United States, 70503
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Waterbury, Connecticut, United States, 06708
    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
    Sunset, Louisiana, United States, 70584
    Status
    Study Complete
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    Location
    GSK Investigational Site
    High Point, North Carolina, United States, 27262
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92120
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fort Worth, Texas, United States, 76104
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Carmichael, California, United States, 95608
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Slidell, Louisiana, United States, 70461
    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
    Larchmont, New York, United States, 10538
    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
    San Antonio, Texas, United States, 78205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Spokane, Washington, United States, 99207
    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
    Fullerton, California, United States, 92835
    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
    Rancho Mirage, California, United States, 92270
    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
    Sepulveda, California, United States, 91343
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Stockton, California, United States, 95207
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Melbourne, Florida, United States, 32935
    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
    Columbus, Ohio, United States, 43215
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63122
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Brandon, Florida, United States, 33511
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15213
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wichita, Kansas, United States, 67207
    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
    New York, New York, United States, 10016
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Minneapolis, Minnesota, United States, 55402
    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
    Johnson City, Tennessee, United States, 37601
    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-16-01
    Actual study completion date
    2007-16-01

    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.

    Additional information about the trial

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