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Completed

NCT Number: NCT00259909

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Bacterial Infections Bacterial Infections and Mycoses Chronic Disease Disease Attributes Infections Infections, Bacterial Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Schwetzingen, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

GSK questionnaire

Other

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

Other

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

Other

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

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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)

  8. 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)

  9. 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)

  10. Physician reported measures at Baseline

    Time frame: Day 1

  11. Physician reported measures at exacerbation

    Time frame: Up to Day 14

  12. Physician reported measures post-exacerbation

    Time frame: Up to Day 14

Secondary outcomes

  1. Change from Baseline in SGRQ-C Total and Subscales Scores

    Time frame: Up to Day 14

  2. Percentage change in SGRQ-C scores

    Time frame: Up to Day 14

  3. Change from Baseline in Acute SF-12v2 Total and Subscales Scores

    Time frame: Up to Day 14

  4. Percentage change in Acute SF-12v2 scores

    Time frame: Up to Day 14

  5. Change from Baseline in Global Efficacy Questionnaire Total and Subscales Scores

    Time frame: Up to Day 14

  6. Percentage change in Global Efficacy Questionnaire scores

    Time frame: Up to Day 14

  7. Change from Baseline in GSK questionnaire Total and Subscales Scores

    Time frame: Up to Day 14

  8. Percentage change in GSK questionnaire scores

    Time frame: Up to Day 14

  9. Time to resolution of each domain score

    Time frame: Up to Day 35

  10. Time to resolution of total domain score

    Time frame: Up to Day 35

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Dec 1, 2005
Registry last updated
Oct 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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