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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive; Infections, Bacterial
• Intervention / Treatment: Other: GSK questionnaire; Other: St. George's Respiratory Questionnaire; Other: Acute Short Form 12 version 2; Other: Global Efficacy questionnaire

• Study Type: Observational
• Enrollment (Actual): 259

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10367
    • GSK Investigational Site
  • Berlin, Germany, 13086
    • GSK Investigational Site
  • Berlin, Germany, 13353
    • GSK Investigational Site
  • Berlin, Germany, 10178
    • GSK Investigational Site
  • Berlin, Germany, 10717
    • GSK Investigational Site
  • Berlin, Germany, 13597
    • GSK Investigational Site
  • Berlin, Germany, 14109
    • GSK Investigational Site
  • Berlin, Germany, 10965
    • GSK Investigational Site
  • Berlin, Germany, 10969
    • GSK Investigational Site
  • Hamburg, Germany, 20357
    • GSK Investigational Site
  • Hamburg, Germany, 22765
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Schwetzingen, Baden-Wuerttemberg, Germany, 68723
      • GSK Investigational Site
    • Weinheim, Baden-Wuerttemberg, Germany, 69469
      • GSK Investigational Site
  • Bayern
    • Bad Woerrishofen, Bayern, Germany, 86825
      • GSK Investigational Site
    • Koetzting, Bayern, Germany, 93444
      • GSK Investigational Site
    • Landsberg, Bayern, Germany, 86899
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 81677
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80336
      • GSK Investigational Site
  • Brandenburg
    • Potsdam, Brandenburg, Germany, 14469
      • GSK Investigational Site
    • Ruedersdorf, Brandenburg, Germany, 15562
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44787
      • GSK Investigational Site
    • Bonn, Nordrhein-Westfalen, Germany, 53119
      • GSK Investigational Site
    • Bonn, Nordrhein-Westfalen, Germany, 53123
      • GSK Investigational Site
    • Dueren, Nordrhein-Westfalen, Germany, 52349
      • GSK Investigational Site
    • Euskirchen, Nordrhein-Westfalen, Germany, 53879
      • GSK Investigational Site
    • Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
      • GSK Investigational Site
    • Luedenscheid, Nordrhein-Westfalen, Germany, 58509
      • GSK Investigational Site
    • Solingen, Nordrhein-Westfalen, Germany, 42651
      • GSK Investigational Site
  • Schleswig-Holstein
    • Geesthacht, Schleswig-Holstein, Germany, 21502
      • GSK Investigational Site
    • Wahlstedt, Schleswig-Holstein, Germany, 23812
      • GSK Investigational Site
• Italy
  • Campania
    • Caserta, Campania, Italy, 81100
      • GSK Investigational Site
    • Eboli (SA), Campania, Italy, 84025
      • GSK Investigational Site
    • Salerno, Campania, Italy, 84126
      • GSK Investigational Site
    • Telese Terme (BN), Campania, Italy, 82037
      • GSK Investigational Site
  • Liguria
    • Genova, Liguria, Italy, 16132
      • GSK Investigational Site
  • Lombardia
    • Rozzano (MI), Lombardia, Italy, 20089
      • GSK Investigational Site
  • Puglia
    • Bari, Puglia, Italy, 70124
      • GSK Investigational Site
    • Foggia, Puglia, Italy, 71100
      • GSK Investigational Site
  • Sicilia
    • Palermo, Sicilia, Italy, 90146
      • GSK Investigational Site
  • Toscana
    • Pisa, Toscana, Italy, 56124
      • GSK Investigational Site
  • Umbria
    • San Martino in Tregnano (Spoleto, PG), Umbria, Italy, 06049
      • GSK Investigational Site
    • San Sisto (PG), Umbria, Italy, 06132
      • GSK Investigational Site
    • Spoleto (PG), Umbria, Italy, 06049
      • GSK Investigational Site
  • Veneto
    • Cittadella (PD), Veneto, Italy, 35013
      • GSK Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • GSK Investigational Site
    • Birmingham, Alabama, United States, 35209
      • GSK Investigational Site
    • Birmingham, Alabama, United States, 35233
      • GSK Investigational Site
    • Huey Town, Alabama, United States, 35023
      • GSK Investigational Site
    • Jasper, Alabama, United States, 35501
      • GSK Investigational Site
  • California
    • Rancho Mirage, California, United States, 92270
      • GSK Investigational Site
    • Riverside, California, United States, 92506
      • GSK Investigational Site
    • San Diego, California, United States, 92120
      • GSK Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80206
      • GSK Investigational Site
    • Fort Collins, Colorado, United States, 80528
      • GSK Investigational Site
    • Wheat Ridge, Colorado, United States, 80033
      • GSK Investigational Site
  • Connecticut
    • Hartford, Connecticut, United States, 06105
      • GSK Investigational Site
    • Hartford, Connecticut, United States, 06106
      • GSK Investigational Site
  • Florida
    • Melbourne, Florida, United States, 32901
      • GSK Investigational Site
    • Pensacola, Florida, United States, 32504
      • GSK Investigational Site
    • Pensacola, Florida, United States, 32503
      • GSK Investigational Site
    • Sarasota, Florida, United States, 34239
      • GSK Investigational Site
    • Tampa, Florida, United States, 33613
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • GSK Investigational Site
    • Austell, Georgia, United States, 30106
      • GSK Investigational Site
    • Decatur, Georgia, United States, 30033
      • GSK Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60612
      • GSK Investigational Site
    • Hines, Illinois, United States, 60141-5099
      • GSK Investigational Site
    • North Chicago, Illinois, United States, 60064
      • GSK Investigational Site
    • Peoria, Illinois, United States, 62526
      • GSK Investigational Site
    • Springfield, Illinois, United States, 62702
      • GSK Investigational Site
  • Indiana
    • Newburgh, Indiana, United States, 47630
      • GSK Investigational Site
    • South Bend, Indiana, United States, 46601
      • GSK Investigational Site
  • Iowa
    • Dubuque, Iowa, United States, 52001
      • GSK Investigational Site
    • Waterloo, Iowa, United States, 50702
      • GSK Investigational Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70806
      • GSK Investigational Site
    • Covington, Louisiana, United States, 70433
      • GSK Investigational Site
    • Lafayette, Louisiana, United States, 70503
      • GSK Investigational Site
    • Sunset, Louisiana, United States, 70584
      • GSK Investigational Site
  • Maine
    • Auburn, Maine, United States, 04210
      • GSK Investigational Site
  • Maryland
    • Towson, Maryland, United States, 21286
      • GSK Investigational Site
  • Michigan
    • DeWitt, Michigan, United States, 48820
      • GSK Investigational Site
    • Detroit, Michigan, United States, 48202
      • GSK Investigational Site
    • Plainwell, Michigan, United States, 49080
      • GSK Investigational Site
    • Richland, Michigan, United States, 49083
      • GSK Investigational Site
    • Saint Joseph, Michigan, United States, 49085
      • GSK Investigational Site
  • Mississippi
    • Picayune, Mississippi, United States, 39466
      • GSK Investigational Site
  • Missouri
    • Columbia, Missouri, United States, 65211
      • GSK Investigational Site
    • Kansas City, Missouri, United States, 64108
      • GSK Investigational Site
    • Kirkwood, Missouri, United States, 63122
      • GSK Investigational Site
    • Saint Charles, Missouri, United States, 63301
      • GSK Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • GSK Investigational Site
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • GSK Investigational Site
    • Summit, New Jersey, United States, 07091
      • GSK Investigational Site
  • New York
    • Buffalo, New York, United States, 14215-1199
      • GSK Investigational Site
    • Great Neck, New York, United States, 11023
      • GSK Investigational Site
    • Kingston, New York, United States, 12401
      • GSK Investigational Site
    • Mineola, New York, United States, 11501
      • GSK Investigational Site
    • New York, New York, United States, 10032
      • GSK Investigational Site
    • New York, New York, United States, 10021
      • GSK Investigational Site
    • New York, New York, United States, 10016
      • GSK Investigational Site
  • North Carolina
    • Elizabeth City, North Carolina, United States, 27909
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45224
      • GSK Investigational Site
    • Columbus, Ohio, United States, 43212
      • GSK Investigational Site
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18102
      • GSK Investigational Site
    • Allentown, Pennsylvania, United States, 19140
      • GSK Investigational Site
    • Audubon, Pennsylvania, United States, 19403
      • GSK Investigational Site
    • King of Prussia, Pennsylvania, United States, 19406
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19140
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15243
      • GSK Investigational Site
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • GSK Investigational Site
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29406-7108
      • GSK Investigational Site
    • Greer, South Carolina, United States, 29651
      • GSK Investigational Site
    • Spartanburg, South Carolina, United States, 29303
      • GSK Investigational Site
    • Summerville, South Carolina, United States, 29485
      • GSK Investigational Site
  • Tennessee
    • Clarksville, Tennessee, United States, 37043
      • GSK Investigational Site
    • Morristown, Tennessee, United States, 37813
      • GSK Investigational Site
  • Texas
    • Corsicana, Texas, United States, 75110
      • GSK Investigational Site
    • Houston, Texas, United States, 77030
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • GSK Investigational Site
    • Richmond, Virginia, United States, 23225
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Subjects with COPD; Subject has a confirmed clinical diagnosis of COPD, with or without chronic bronchitis.

Other: GSK questionnaire; 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.; Other: St. George's Respiratory Questionnaire; 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.; Other: Acute Short Form 12 version 2; 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; Other: Global Efficacy questionnaire; Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	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.	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.	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)	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)	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)	Up to Day 14
Physician reported measures at Baseline		Day 1
Physician reported measures at exacerbation		Up to Day 14
Physician reported measures post-exacerbation		Up to Day 14

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in SGRQ-C Total and Subscales Scores	Up to Day 14
Percentage change in SGRQ-C scores	Up to Day 14
Change from Baseline in Acute SF-12v2 Total and Subscales Scores	Up to Day 14
Percentage change in Acute SF-12v2 scores	Up to Day 14
Change from Baseline in Global Efficacy Questionnaire Total and Subscales Scores	Up to Day 14
Percentage change in Global Efficacy Questionnaire scores	Up to Day 14
Change from Baseline in GSK questionnaire Total and Subscales Scores	Up to Day 14
Percentage change in GSK questionnaire scores	Up to Day 14
Time to resolution of each domain score	Up to Day 35
Time to resolution of total domain score	Up to Day 35

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2005
• Primary Completion (Actual): November 7, 2006
• Study Completion (Actual): November 7, 2006

Study Registration Dates

• First Submitted: November 29, 2005
• First Submitted That Met QC Criteria: November 30, 2005
• First Posted (Estimate): December 1, 2005

Study Record Updates

• Last Update Posted (Actual): October 12, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Patient reported outcomes; COPD; acute exacerbation of chronic obstructive pulmonary disease (AECOPD)
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Bacterial Infections and Mycoses; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Bacterial Infections
• Other Study ID Numbers: OPL104226

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No