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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
Not applicable
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
GSK Investigational Site
East Providence, Rhode Island, United States, 02914
Status
Study Complete
Location
GSK Investigational Site
St. Charles, Missouri, United States, 63301
Status
Study Complete
Location
GSK Investigational Site
Dueren, Nordrhein-Westfalen, Germany, 52349
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14215-1199
Status
Study Complete
Location
GSK Investigational Site
Richland, Michigan, United States, 49083
Status
Study Complete
Location
GSK Investigational Site
Sarasota, Florida, United States, 34239
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Martino in Tregnano (Spoleto, PG), Umbria, Italy, 06049
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Koetzting, Bayern, Germany, 93444
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St. Joseph, Michigan, United States, 49085
Status
Study Complete
Location
GSK Investigational Site
Newburgh, Indiana, United States, 47630
Status
Study Complete
Location
GSK Investigational Site
Great Neck, New York, United States, 11023
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15243
Status
Study Complete
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70806
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48202
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80206
Status
Study Complete
Location
GSK Investigational Site
Picayune, Mississippi, United States, 39466
Status
Study Complete
Location
GSK Investigational Site
Morristown, Tennessee, United States, 37813
Status
Study Complete
Location
GSK Investigational Site
Austell, Georgia, United States, 30106
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Summerville, South Carolina, United States, 29485
Status
Study Complete
Location
GSK Investigational Site
Allentown, Pennsylvania, United States, 18102
Status
Study Complete
Location
GSK Investigational Site
Bad Woerrishofen, Bayern, Germany, 86825
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35233
Status
Study Complete
Location
GSK Investigational Site
Springfield, Illinois, United States, 62702
Status
Study Complete
Location
GSK Investigational Site
Covington, Louisiana, United States, 70433
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lafayette, Louisiana, United States, 70503
Status
Study Complete
Location
GSK Investigational Site
Lynchburg, Virginia, United States, 24501
Status
Study Complete
Location
GSK Investigational Site
Kirkwood, Missouri, United States, 63122
Status
Study Complete
Location
GSK Investigational Site
Columbia, Missouri, United States, 65211
Status
Study Complete
Location
GSK Investigational Site
Pensacola, Florida, United States, 32503
Status
Study Complete
Location
GSK Investigational Site
Fort Collins, Colorado, United States, 80528
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Study Complete
Location
GSK Investigational Site
Pensacola, Florida, United States, 32504
Status
Study Complete
Location
GSK Investigational Site
Hartford, Connecticut, United States, 06105
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45224
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rancho Mirage, California, United States, 92270
Status
Study Complete
Location
GSK Investigational Site
Euskirchen, Nordrhein-Westfalen, Germany, 53879
Status
Study Complete
Location
GSK Investigational Site
Allentown, Pennsylvania, United States, 19140
Status
Study Complete
Location
GSK Investigational Site
King of Prussia, Pennsylvania, United States, 19406
Status
Study Complete
Location
GSK Investigational Site
Ruedersdorf, Brandenburg, Germany, 15562
Status
Study Complete
Location
GSK Investigational Site
Dewitte, Michigan, United States, 48820
Status
Study Complete
Location
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53123
Status
Study Complete
Location
GSK Investigational Site
Melbourne, Florida, United States, 32901
Status
Study Complete
Location
GSK Investigational Site
Solingen, Nordrhein-Westfalen, Germany, 42651
Status
Study Complete
Location
GSK Investigational Site
Hines, Illinois, United States, 60141-5099
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
South Bend, Indiana, United States, 46601
Status
Study Complete
Location
GSK Investigational Site
Corsicana, Texas, United States, 75110
Status
Study Complete
Location
GSK Investigational Site
Mineola, New York, United States, 11501
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
Hartford, Connecticut, United States, 06106
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Decatur, Georgia, United States, 30033
Status
Study Complete
Location
GSK Investigational Site
Audubon, Pennsylvania, United States, 19403
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany, 21502
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10032
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Richmond, Virginia, United States, 23225
Status
Study Complete
Location
GSK Investigational Site
Kingston, New York, United States, 12401
Status
Study Complete
Location
GSK Investigational Site
Schwetzingen, Baden-Wuerttemberg, Germany, 68723
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64108
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Jasper, Alabama, United States, 35501
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Telese Terme (BN), Campania, Italy, 82037
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 80336
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Study Complete
Location
GSK Investigational Site
Wahlstedt, Schleswig-Holstein, Germany, 23812
Status
Study Complete
Location
GSK Investigational Site
Huey Town, Alabama, United States, 35023
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44787
Status
Study Complete
Location
GSK Investigational Site
North Chicago, Illinois, United States, 60064
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406-7108
Status
Study Complete
Location
GSK Investigational Site
plymouth Meeting, Pennsylvania, United States, 19462
Status
Study Complete
Location
GSK Investigational Site
Towson, Maryland, United States, 21286
Status
Study Complete
Location
GSK Investigational Site
Clarksville, Tennessee, United States, 37043
Status
Study Complete
Location
GSK Investigational Site
Plainwell, Michigan, United States, 49080
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Summit, New Jersey, United States, 07091
Status
Study Complete
Location
GSK Investigational Site
Peoria, Illinois, United States, 62526
Status
Study Complete
Location
GSK Investigational Site
Luedenscheid, Nordrhein-Westfalen, Germany, 58509
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Elizabeth City, North Carolina, United States, 27909
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
East Brunswick, New Jersey, United States, 08816
Status
Study Complete
Location
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Status
Study Complete
Location
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53119
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35209
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
Status
Study Complete
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
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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