We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00259909
First Posted: December 1, 2005
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study for the Psychometric Validation of a Patient-reported Questionnaire in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline [ Time Frame: 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

  • SGRQ Scores at exacerbation [ Time Frame: 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 [ Time Frame: 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

  • Acute Short Form 12 version 2 (Acute SF-12v2) scores at Baseline [ Time Frame: 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.

  • Acute SF-12v2 scores at exacerbation [ Time Frame: 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.

  • Acute SF-12v2 scores post-exacerbation [ Time Frame: 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 Baseline [ Time Frame: Day 1 ]
    Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)

  • Global Efficacy questionnaire scores at exacerbation [ Time Frame: 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)

  • Global Efficacy questionnaire scores post-exacerbation [ Time Frame: 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 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 259
Actual Study Start Date: November 2, 2005
Study Completion Date: November 7, 2006
Primary Completion Date: November 7, 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259909


  Show 123 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00259909     History of Changes
Other Study ID Numbers: OPL104226
First Submitted: November 29, 2005
First Posted: December 1, 2005
Last Update Posted: October 12, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
Patient reported outcomes
COPD
acute exacerbation of chronic obstructive pulmonary disease (AECOPD)

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Bacterial Infections
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes