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

Completed

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

• Registration Number: NCT00259909
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-11-02
• Study First Submitted: 2005-11-29
• Study First Submitted QC: 2005-11-30
• Study First Posted: 2005-12-01
• Primary Completion: 2006-11-07
• Study Completion: 2006-11-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 259

Inclusion Criteria

• 15 pack-year smoking history.
• Confirmed diagnosis of COPD.
• Have two documented episodes of acute exacerbation in past 12 months.

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Exclusion Criteria

• Clinical diagnosis of asthma.
• Subjects not literate in the language of the questionnaire (e.g. US English).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with COPD	Global Efficacy questionnaire	Subject has a confirmed clinical diagnosis of COPD, with or without chronic bronchitis.
Subjects with COPD	GSK questionnaire	Subject has a confirmed clinical diagnosis of COPD, with or without chronic bronchitis.
Subjects with COPD	Acute Short Form 12 version 2	Subject has a confirmed clinical diagnosis of COPD, with or without chronic bronchitis.
Subjects with COPD	St. George's Respiratory Questionnaire	Subject has a confirmed clinical diagnosis of COPD, with or without chronic bronchitis.

Primary Outcome Measures

Name	Time	Method
SGRQ Scores at exacerbation	Up to Day 14	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
SGRQ Scores post-exacerbation	Up to Day 14	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
Global Efficacy questionnaire scores post-exacerbation	Up to Day 14	Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)
Physician reported measures post-exacerbation	Up to Day 14
Acute SF-12v2 scores at exacerbation	Up to Day 14	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.
St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline	Day 1	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
Physician reported measures at Baseline	Day 1
Acute Short Form 12 version 2 (Acute SF-12v2) scores at Baseline	Day 1	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.
Global Efficacy questionnaire scores at Baseline	Day 1	Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)
Acute SF-12v2 scores post-exacerbation	Up to Day 14	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.
Global Efficacy questionnaire scores at exacerbation	Up to Day 14	Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)
Physician reported measures at exacerbation	Up to Day 14

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇮🇹 Cittadella (PD), Veneto, Italy