Last updated: 11/04/2018 10:06:47

Observational Study Of An Electronic Questionnaire In Patients With Chronic Obstructive Pulmonary Disease (COPD)

GSK study ID
OPL104226
Clinicaltrials.gov ID
NCT00259909
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 prospective observational study for the psychometric validation of a patient-reported questionnaire in acute exacerbations of chronic obstructive pulmonary disease (AECOPD)
Trial description: The aim of the study is to develop a new patient-reported outcome (PRO) questionnaire measuring the impact of an acute exacerbation on daily lives of patients with chronic obstructive pulmonary disease (COPD). This questionnaire will aim to detect an acute exacerbation and resolution of exacerbation from the patient’s perspective. At a later stage of development, this questionnaire will be able to measure the effect of anti bacterials in the treatment of acute exacerbations of COPD (AECOPD). This study will evaluate the factor structure, validity, reliability, and responsiveness of the GSK questionnaire in subjects who experience acute exacerbations of their COPD.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline

Timeframe: Day 1

SGRQ Scores at exacerbation

Timeframe: Up to Day 14

SGRQ Scores post-exacerbation

Timeframe: Up to Day 14

Acute Short Form 12 version 2 (Acute SF-12v2) scores at Baseline

Timeframe: Day 1

Acute SF-12v2 scores at exacerbation

Timeframe: Up to Day 14

Acute SF-12v2 scores post-exacerbation

Timeframe: Up to Day 14

Global Efficacy questionnaire scores at Baseline

Timeframe: Day 1

Global Efficacy questionnaire scores at exacerbation

Timeframe: Up to Day 14

Global Efficacy questionnaire scores post-exacerbation

Timeframe: Up to Day 14

Physician reported measures at Baseline

Timeframe: Day 1

Physician reported measures at exacerbation

Timeframe: Up to Day 14

Physician reported measures post-exacerbation

Timeframe: Up to Day 14

Secondary outcomes:

Change from Baseline in SGRQ-C Total and Subscales Scores

Timeframe: Up to Day 14

Percentage change in SGRQ-C scores

Timeframe: Up to Day 14

Change from Baseline in Acute SF-12v2 Total and Subscales Scores

Timeframe: Up to Day 14

Percentage change in Acute SF-12v2 scores

Timeframe: Up to Day 14

Change from Baseline in Global Efficacy Questionnaire Total and Subscales Scores

Timeframe: Up to Day 14

Percentage change in Global Efficacy Questionnaire scores

Timeframe: Up to Day 14

Change from Baseline in GSK questionnaire Total and Subscales Scores

Timeframe: Up to Day 14

Percentage change in GSK questionnaire scores

Timeframe: Up to Day 14

Time to resolution of each domain score

Timeframe: Up to Day 35

Time to resolution of total domain score

Timeframe: Up to Day 35

Interventions:
  • Other: GSK questionnaire
  • Other: St. George's Respiratory Questionnaire
  • Other: Acute Short Form 12 version 2
  • Other: Global Efficacy questionnaire
    • Enrollment:
    259
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive, Infections, Bacterial
    Product
    SB742510
    Collaborators
    Not applicable
    Study date(s)
    November 2005 to November 2006
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • 15 pack-year smoking history.
    • Confirmed diagnosis of COPD.
    • Clinical diagnosis of asthma.
    • Subjects not literate in the language of the questionnaire (e.g. US English).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 15 pack-year smoking history.
    • Confirmed diagnosis of COPD.
    • Have two documented episodes of acute exacerbation in past 12 months.
    Exclusion criteria:
    • Clinical diagnosis of asthma.
    • Subjects not literate in the language of the questionnaire (e.g. US English).

    Trial location(s)

    Location
    Status
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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
    Berlin, Berlin, Germany, 13597
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10717
    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
    Genova, Liguria, Italy, 16132
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dueren, Nordrhein-Westfalen, Germany, 52349
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Buffalo, New York, United States, 14215-1199
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Richland, Michigan, United States, 49083
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sarasota, Florida, United States, 34239
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    San Martino in Tregnano (Spoleto, PG), Umbria, Italy, 06049
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Koetzting, Bayern, Germany, 93444
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68131
    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
    Newburgh, Indiana, United States, 47630
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Great Neck, New York, United States, 11023
    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
    Baton Rouge, Louisiana, United States, 70806
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Detroit, Michigan, United States, 48202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Denver, Colorado, United States, 80206
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77030
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Picayune, Mississippi, United States, 39466
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Palermo, Sicilia, Italy, 90146
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Morristown, Tennessee, United States, 37813
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Austell, Georgia, United States, 30106
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Summerville, South Carolina, United States, 29485
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Allentown, Pennsylvania, United States, 18102
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10178
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bad Woerrishofen, Bayern, Germany, 86825
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35233
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Caserta, Campania, Italy, 81100
    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
    Covington, Louisiana, United States, 70433
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10969
    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
    Lynchburg, Virginia, United States, 24501
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10965
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kirkwood, Missouri, United States, 63122
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 14109
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Sisto (PG), Umbria, Italy, 06132
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbia, Missouri, United States, 65211
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pensacola, Florida, United States, 32503
    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
    Spoleto (PG), Umbria, Italy, 06049
    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
    Pensacola, Florida, United States, 32504
    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
    Cincinnati, Ohio, United States, 45224
    Status
    Terminated/Withdrawn
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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
    Euskirchen, Nordrhein-Westfalen, Germany, 53879
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Allentown, Pennsylvania, United States, 19140
    Status
    Study Complete
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    Location
    GSK Investigational Site
    King of Prussia, Pennsylvania, United States, 19406
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ruedersdorf, Brandenburg, Germany, 15562
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dewitte, Michigan, United States, 48820
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13086
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bonn, Nordrhein-Westfalen, Germany, 53123
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Melbourne, Florida, United States, 32901
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Solingen, Nordrhein-Westfalen, Germany, 42651
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hines, Illinois, United States, 60141-5099
    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
    Landsberg, Bayern, Germany, 86899
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Potsdam, Brandenburg, Germany, 14469
    Status
    Study Complete
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    Location
    GSK Investigational Site
    South Bend, Indiana, United States, 46601
    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
    Rozzano (MI), Lombardia, Italy, 20089
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mineola, New York, United States, 11501
    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
    Dubuque, Iowa, United States, 52001
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10367
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hartford, Connecticut, United States, 06106
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bari, Puglia, Italy, 70124
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Eboli (SA), Campania, Italy, 84025
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbus, Ohio, United States, 43212
    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
    Audubon, Pennsylvania, United States, 19403
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Geesthacht, Schleswig-Holstein, Germany, 21502
    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
    Muenchen, Bayern, Germany, 81677
    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
    New York, New York, United States, 10032
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Weinheim, Baden-Wuerttemberg, Germany, 69469
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Greer, South Carolina, United States, 29651
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23225
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kingston, New York, United States, 12401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Schwetzingen, Baden-Wuerttemberg, Germany, 68723
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cittadella (PD), Veneto, Italy, 35013
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kansas City, Missouri, United States, 64108
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33613
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jasper, Alabama, United States, 35501
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    New York, New York, United States, 10021
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Telese Terme (BN), Campania, Italy, 82037
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Muenchen, Bayern, Germany, 80336
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60612
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hamburg, Hamburg, Germany, 22765
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wahlstedt, Schleswig-Holstein, Germany, 23812
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Foggia, Puglia, Italy, 71100
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Huey Town, Alabama, United States, 35023
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bochum, Nordrhein-Westfalen, Germany, 44787
    Status
    Study Complete
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    Location
    GSK Investigational Site
    North Chicago, Illinois, United States, 60064
    Status
    Terminated/Withdrawn
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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
    plymouth Meeting, Pennsylvania, United States, 19462
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Towson, Maryland, United States, 21286
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Clarksville, Tennessee, United States, 37043
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Plainwell, Michigan, United States, 49080
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Summit, New Jersey, United States, 07091
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Peoria, Illinois, United States, 62526
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Luedenscheid, Nordrhein-Westfalen, Germany, 58509
    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
    Elizabeth City, North Carolina, United States, 27909
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Waterloo, Iowa, United States, 50702
    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
    East Brunswick, New Jersey, United States, 08816
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wheat Ridge, Colorado, United States, 80033
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Pisa, Toscana, Italy, 56124
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13353
    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
    Salerno, Campania, Italy, 84126
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Winston-Salem, North Carolina, United States, 27103
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35294
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19140
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bonn, Nordrhein-Westfalen, Germany, 53119
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hamburg, Hamburg, Germany, 20357
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35209
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
    Status
    Study Complete
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    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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