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.
Study Type
OBSERVATIONAL
Enrollment
259
GSK questionnaire will demonstrate the validity, reliability and responsiveness as a tool for measuring subject-reported outcomes during an acute exacerbation of chronic obstructive pulmonary disease.
The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ sub-scores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health.
The Acute SF-12v2 is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of health
Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)
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
St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline
The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ sub-scores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. A change in the Total score of 4 units is consistent with a clinically significant change in the subject
Time frame: Day 1
SGRQ Scores at exacerbation
The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ sub-scores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. A change in the Total score of 4 units is consistent with a clinically significant change in the subject
Time frame: Up to Day 14
SGRQ Scores post-exacerbation
The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ sub-scores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. A change in the Total score of 4 units is consistent with a clinically significant change in the subject
Time frame: Up to Day 14
Acute Short Form 12 version 2 (Acute SF-12v2) scores at Baseline
The Acute SF-12v2 is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of health. It has been translated and validated in most major languages. The Acute SF-12v2 is self-administered by patients, and completed on average in 2 minutes or less.
Time frame: Day 1
Acute SF-12v2 scores at exacerbation
The Acute SF-12v2 is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of health. It has been translated and validated in most major languages. The Acute SF-12v2 is self-administered by patients, and completed on average in 2 minutes or less.
Time frame: Up to Day 14
Acute SF-12v2 scores post-exacerbation
The Acute SF-12v2 is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of health. It has been translated and validated in most major languages. The Acute SF-12v2 is self-administered by patients, and completed on average in 2 minutes or less.
Time frame: Up to Day 14
Global Efficacy questionnaire scores at Baseline
Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)
Time frame: Day 1
Global Efficacy questionnaire scores at exacerbation
Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)
Time frame: Up to Day 14
Global Efficacy questionnaire scores post-exacerbation
Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)
Time frame: Up to Day 14
Physician reported measures at Baseline
Time frame: Day 1
Physician reported measures at exacerbation
Time frame: Up to Day 14
Physician reported measures post-exacerbation
Time frame: Up to Day 14
Change from Baseline in SGRQ-C Total and Subscales Scores
Time frame: Up to Day 14
Percentage change in SGRQ-C scores
Time frame: Up to Day 14
Change from Baseline in Acute SF-12v2 Total and Subscales Scores
Time frame: Up to Day 14
Percentage change in Acute SF-12v2 scores
Time frame: Up to Day 14
Change from Baseline in Global Efficacy Questionnaire Total and Subscales Scores
Time frame: Up to Day 14
Percentage change in Global Efficacy Questionnaire scores
Time frame: Up to Day 14
Change from Baseline in GSK questionnaire Total and Subscales Scores
Time frame: Up to Day 14
Percentage change in GSK questionnaire scores
Time frame: Up to Day 14
Time to resolution of each domain score
Time frame: Up to Day 35
Time to resolution of total domain score
Time frame: Up to Day 35
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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
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