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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 40 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: Subject has a confirmed clinical diagnosis of COPD, with or without chronic bronchitis were included in the study

Trial locations and contacts

123 sites in 3 countries.

About this study

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

Conditions

Pulmonary Disease, Chronic Obstructive, Infections, Bacterial

Being tested

GSK questionnaire, St. George's Respiratory Questionnaire, Acute Short Form 12 version 2, Global Efficacy questionnaire

Keywords

Patient reported outcomes, COPD, acute exacerbation of chronic obstructive pulmonary disease (AECOPD)

Medical subject headings

Pulmonary Disease, Chronic Obstructive, Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• GSK questionnaireOther

  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 QuestionnaireOther

  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 2Other

  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 questionnaireOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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

   Measured: Day 1

2. 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

   Measured: Up to Day 14

3. 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

   Measured: Up to Day 14

4. 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.

   Measured: Day 1

5. 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.

   Measured: Up to Day 14

6. 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.

   Measured: Up to Day 14

7. 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)

   Measured: Day 1

8. 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)

   Measured: Up to Day 14

9. 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)

   Measured: Up to Day 14

10. Physician reported measures at Baseline

    Measured: Day 1

11. Physician reported measures at exacerbation

    Measured: Up to Day 14

12. Physician reported measures post-exacerbation

    Measured: Up to Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted1 Dec 2005 (estimated)
2. Study start2 Nov 2005
3. Primary completion7 Nov 2006
4. Study completion7 Nov 2006

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
• More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.