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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Prospective Observational Study for the Psychometric Validation of a Patient-reported Questionnaire in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259909
• Other study ID #: OPL104226
• Status: Completed
• Phase: N/A
• First received: November 29, 2005
• Last updated: October 10, 2017
• Start date: November 2, 2005
• Est. completion date: November 7, 2006

Study information

• Verified date: October 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: November 7, 2006
• Est. primary completion date: November 7, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Bacterial Infections
• Chronic Disease
• Infections, Bacterial
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.
• 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
• Global Efficacy questionnaire
Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Bad Woerrishofen	Bayern
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bonn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bonn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Dueren	Nordrhein-Westfalen
Germany	GSK Investigational Site	Euskirchen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Geesthacht	Schleswig-Holstein
Germany	GSK Investigational Site	Gelsenkirchen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Koetzting	Bayern
Germany	GSK Investigational Site	Landsberg	Bayern
Germany	GSK Investigational Site	Luedenscheid	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Potsdam	Brandenburg
Germany	GSK Investigational Site	Ruedersdorf	Brandenburg
Germany	GSK Investigational Site	Schwetzingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Solingen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wahlstedt	Schleswig-Holstein
Germany	GSK Investigational Site	Weinheim	Baden-Wuerttemberg
Italy	GSK Investigational Site	Bari	Puglia
Italy	GSK Investigational Site	Caserta	Campania
Italy	GSK Investigational Site	Cittadella (PD)	Veneto
Italy	GSK Investigational Site	Eboli (SA)	Campania
Italy	GSK Investigational Site	Foggia	Puglia
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Palermo	Sicilia
Italy	GSK Investigational Site	Pisa	Toscana
Italy	GSK Investigational Site	Rozzano (MI)	Lombardia
Italy	GSK Investigational Site	Salerno	Campania
Italy	GSK Investigational Site	San Martino in Tregnano (Spoleto, PG)	Umbria
Italy	GSK Investigational Site	San Sisto (PG)	Umbria
Italy	GSK Investigational Site	Spoleto (PG)	Umbria
Italy	GSK Investigational Site	Telese Terme (BN)	Campania
United States	GSK Investigational Site	Allentown	Pennsylvania
United States	GSK Investigational Site	Allentown	Pennsylvania
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Auburn	Maine
United States	GSK Investigational Site	Audubon	Pennsylvania
United States	GSK Investigational Site	Austell	Georgia
United States	GSK Investigational Site	Baton Rouge	Louisiana
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Buffalo	New York
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Clarksville	Tennessee
United States	GSK Investigational Site	Columbia	Missouri
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Corsicana	Texas
United States	GSK Investigational Site	Covington	Louisiana
United States	GSK Investigational Site	Decatur	Georgia
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	DeWitt	Michigan
United States	GSK Investigational Site	Dubuque	Iowa
United States	GSK Investigational Site	East Brunswick	New Jersey
United States	GSK Investigational Site	East Providence	Rhode Island
United States	GSK Investigational Site	Elizabeth City	North Carolina
United States	GSK Investigational Site	Fort Collins	Colorado
United States	GSK Investigational Site	Great Neck	New York
United States	GSK Investigational Site	Greer	South Carolina
United States	GSK Investigational Site	Hartford	Connecticut
United States	GSK Investigational Site	Hartford	Connecticut
United States	GSK Investigational Site	Hines	Illinois
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huey Town	Alabama
United States	GSK Investigational Site	Jasper	Alabama
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	King of Prussia	Pennsylvania
United States	GSK Investigational Site	Kingston	New York
United States	GSK Investigational Site	Kirkwood	Missouri
United States	GSK Investigational Site	Lafayette	Louisiana
United States	GSK Investigational Site	Lynchburg	Virginia
United States	GSK Investigational Site	Melbourne	Florida
United States	GSK Investigational Site	Mineola	New York
United States	GSK Investigational Site	Morristown	Tennessee
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Newburgh	Indiana
United States	GSK Investigational Site	North Chicago	Illinois
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Pensacola	Florida
United States	GSK Investigational Site	Pensacola	Florida
United States	GSK Investigational Site	Peoria	Illinois
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Picayune	Mississippi
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Plainwell	Michigan
United States	GSK Investigational Site	Plymouth Meeting	Pennsylvania
United States	GSK Investigational Site	Rancho Mirage	California
United States	GSK Investigational Site	Richland	Michigan
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Riverside	California
United States	GSK Investigational Site	Saint Charles	Missouri
United States	GSK Investigational Site	Saint Joseph	Michigan
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Sarasota	Florida
United States	GSK Investigational Site	South Bend	Indiana
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Springfield	Illinois
United States	GSK Investigational Site	Summerville	South Carolina
United States	GSK Investigational Site	Summit	New Jersey
United States	GSK Investigational Site	Sunset	Louisiana
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Towson	Maryland
United States	GSK Investigational Site	Waterloo	Iowa
United States	GSK Investigational Site	Wheat Ridge	Colorado
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Physician reported measures at Baseline		Day 1
Primary	Physician reported measures at exacerbation		Up to Day 14
Primary	Physician reported measures post-exacerbation		Up to Day 14
Secondary	Change from Baseline in SGRQ-C Total and Subscales Scores		Up to Day 14
Secondary	Percentage change in SGRQ-C scores		Up to Day 14
Secondary	Change from Baseline in Acute SF-12v2 Total and Subscales Scores		Up to Day 14
Secondary	Percentage change in Acute SF-12v2 scores		Up to Day 14
Secondary	Change from Baseline in Global Efficacy Questionnaire Total and Subscales Scores		Up to Day 14
Secondary	Percentage change in Global Efficacy Questionnaire scores		Up to Day 14
Secondary	Change from Baseline in GSK questionnaire Total and Subscales Scores		Up to Day 14
Secondary	Percentage change in GSK questionnaire scores		Up to Day 14
Secondary	Time to resolution of each domain score		Up to Day 35
Secondary	Time to resolution of total domain score		Up to Day 35