Clinical trial NCT00259909: Observational Study Of An Electronic Questionnaire In Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Prospective Observational Study for the Psychometric Validation of a Patient-reported Questionnaire in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Infections, Bacterial
Keywords: Patient reported outcomes
COPD
acute exacerbation of chronic obstructive pulmonary disease (AECOPD)
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-12-01
Enrollment: 259
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject has a confirmed clinical diagnosis of COPD, with or without chronic bronchitis were included in the study

Brief summary: 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.


Eligibility 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).

Primary outcomes:
measure: St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline
timeFrame: Day 1
measure: SGRQ Scores at exacerbation
timeFrame: Up to Day 14
measure: SGRQ Scores post-exacerbation
timeFrame: Up to Day 14
measure: Acute Short Form 12 version 2 (Acute SF-12v2) scores at Baseline
timeFrame: Day 1
measure: Acute SF-12v2 scores at exacerbation
timeFrame: Up to Day 14
measure: Acute SF-12v2 scores post-exacerbation
timeFrame: Up to Day 14
measure: Global Efficacy questionnaire scores at Baseline
timeFrame: Day 1
measure: Global Efficacy questionnaire scores at exacerbation
timeFrame: Up to Day 14
measure: Global Efficacy questionnaire scores post-exacerbation
timeFrame: Up to Day 14
measure: Physician reported measures at Baseline
timeFrame: Day 1
measure: Physician reported measures at exacerbation
timeFrame: Up to Day 14
measure: Physician reported measures post-exacerbation
timeFrame: Up to Day 14
Secondary outcomes:
measure: Change from Baseline in SGRQ-C Total and Subscales Scores
timeFrame: Up to Day 14
measure: Percentage change in SGRQ-C scores
timeFrame: Up to Day 14
measure: Change from Baseline in Acute SF-12v2 Total and Subscales Scores
timeFrame: Up to Day 14
measure: Percentage change in Acute SF-12v2 scores
timeFrame: Up to Day 14
measure: Change from Baseline in Global Efficacy Questionnaire Total and Subscales Scores
timeFrame: Up to Day 14
measure: Percentage change in Global Efficacy Questionnaire scores
timeFrame: Up to Day 14
measure: Change from Baseline in GSK questionnaire Total and Subscales Scores
timeFrame: Up to Day 14
measure: Percentage change in GSK questionnaire scores
timeFrame: Up to Day 14
measure: Time to resolution of each domain score
timeFrame: Up to Day 35
measure: Time to resolution of total domain score
timeFrame: Up to Day 35
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Huey Town
country: United States
facility: GSK Investigational Site
state: Alabama
city: Jasper
country: United States
facility: GSK Investigational Site
state: Alabama
city: Rancho Mirage
country: United States
facility: GSK Investigational Site
state: California
city: Riverside
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Fort Collins
country: United States
facility: GSK Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: GSK Investigational Site
state: Colorado
city: Hartford
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Hartford
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Melbourne
country: United States
facility: GSK Investigational Site
state: Florida
city: Pensacola
country: United States
facility: GSK Investigational Site
state: Florida
city: Pensacola
country: United States
facility: GSK Investigational Site
state: Florida
city: Sarasota
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Austell
country: United States
facility: GSK Investigational Site
state: Georgia
city: Decatur
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Hines
country: United States
facility: GSK Investigational Site
state: Illinois
city: North Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Peoria
country: United States
facility: GSK Investigational Site
state: Illinois
city: Springfield
country: United States
facility: GSK Investigational Site
state: Illinois
city: Newburgh
country: United States
facility: GSK Investigational Site
state: Indiana
city: South Bend
country: United States
facility: GSK Investigational Site
state: Indiana
city: Dubuque
country: United States
facility: GSK Investigational Site
state: Iowa
city: Waterloo
country: United States
facility: GSK Investigational Site
state: Iowa
city: Baton Rouge
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Covington
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Lafayette
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Sunset
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Auburn
country: United States
facility: GSK Investigational Site
state: Maine
city: Towson
country: United States
facility: GSK Investigational Site
state: Maryland
city: Detroit
country: United States
facility: GSK Investigational Site
state: Michigan
city: DeWitt
country: United States
facility: GSK Investigational Site
state: Michigan
city: Plainwell
country: United States
facility: GSK Investigational Site
state: Michigan
city: Richland
country: United States
facility: GSK Investigational Site
state: Michigan
city: Saint Joseph
country: United States
facility: GSK Investigational Site
state: Michigan
city: Picayune
country: United States
facility: GSK Investigational Site
state: Mississippi
city: Columbia
country: United States
facility: GSK Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Kirkwood
country: United States
facility: GSK Investigational Site
state: Missouri
city: Saint Charles
country: United States
facility: GSK Investigational Site
state: Missouri
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: East Brunswick
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Summit
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Buffalo
country: United States
facility: GSK Investigational Site
state: New York
city: Great Neck
country: United States
facility: GSK Investigational Site
state: New York
city: Kingston
country: United States
facility: GSK Investigational Site
state: New York
city: Mineola
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Elizabeth City
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Allentown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Allentown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Audubon
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: King of Prussia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: East Providence
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Greer
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Summerville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Clarksville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Morristown
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Corsicana
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Lynchburg
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Schwetzingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Weinheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Bad Woerrishofen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Koetzting
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Landsberg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Potsdam
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Ruedersdorf
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dueren
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Euskirchen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Gelsenkirchen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Luedenscheid
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Solingen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Geesthacht
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Wahlstedt
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Caserta
country: Italy
facility: GSK Investigational Site
state: Campania
city: Eboli (SA)
country: Italy
facility: GSK Investigational Site
state: Campania
city: Salerno
country: Italy
facility: GSK Investigational Site
state: Campania
city: Telese Terme (BN)
country: Italy
facility: GSK Investigational Site
state: Campania
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Rozzano (MI)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Bari
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Foggia
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Palermo
country: Italy
facility: GSK Investigational Site
state: Sicilia
city: Pisa
country: Italy
facility: GSK Investigational Site
state: Toscana
city: San Martino in Tregnano (Spoleto, PG)
country: Italy
facility: GSK Investigational Site
state: Umbria
city: San Sisto (PG)
country: Italy
facility: GSK Investigational Site
state: Umbria
city: Spoleto (PG)
country: Italy
facility: GSK Investigational Site
state: Umbria
city: Cittadella (PD)
country: Italy
facility: GSK Investigational Site
state: Veneto
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: