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A Prospective Observational Study for the Psychometric Validation of a Patient-reported Questionnaire in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
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.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Hueytown, Alabama, United States
GSK Investigational Site
Jasper, Alabama, United States
GSK Investigational Site
Rancho Mirage, California, United States
GSK Investigational Site
Riverside, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Fort Collins, Colorado, United States
Start Date
November 2, 2005
Primary Completion Date
November 7, 2006
Completion Date
November 7, 2006
Last Updated
October 12, 2017
259
ACTUAL participants
GSK questionnaire
OTHER
St. George's Respiratory Questionnaire
OTHER
Acute Short Form 12 version 2
OTHER
Global Efficacy questionnaire
OTHER
Lead Sponsor
GlaxoSmithKline
NCT06831994
NCT06451172
Data Source & Attribution
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