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

NCT00259909 | Completed

• 1 other identifier: OPL104226
• Study Type: observational
• Target: 259
• Locations: 3 countries
• Sites: 123

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Infections, Bacterial

Keywords

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

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Physician reported measures at Baseline

  Day 1

• Physician reported measures at exacerbation

  Up to Day 14

• Physician reported measures post-exacerbation

  Up to Day 14

Secondary Outcomes (10)

• Change from Baseline in SGRQ-C Total and Subscales Scores

  Up to Day 14

• Percentage change in SGRQ-C scores

  Up to Day 14

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

  Up to Day 14

• 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

Study Arms (1)

Subjects with COPD

Subject has a confirmed clinical diagnosis of COPD, with or without chronic bronchitis.

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

Interventions

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.

Subjects with COPD

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.

Subjects with COPD

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

Subjects with COPD

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)

Subjects with COPD

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (123)

GSK Investigational Site

Birmingham, Alabama, 35209, United States

Location

GSK Investigational Site

Birmingham, Alabama, 35233, United States

Location

GSK Investigational Site

Birmingham, Alabama, 35294, United States

Location

GSK Investigational Site

Hueytown, Alabama, 35023, United States

Location

GSK Investigational Site

Jasper, Alabama, 35501, United States

Location

GSK Investigational Site

Rancho Mirage, California, 92270, United States

Location

GSK Investigational Site

Riverside, California, 92506, United States

Location

GSK Investigational Site

San Diego, California, 92120, United States

Location

GSK Investigational Site

Denver, Colorado, 80206, United States

Location

GSK Investigational Site

Fort Collins, Colorado, 80528, United States

Location

GSK Investigational Site

Wheat Ridge, Colorado, 80033, United States

Location

GSK Investigational Site

Hartford, Connecticut, 06105, United States

Location

GSK Investigational Site

Hartford, Connecticut, 06106, United States

Location

GSK Investigational Site

Melbourne, Florida, 32901, United States

Location

GSK Investigational Site

Pensacola, Florida, 32503, United States

Location

GSK Investigational Site

Pensacola, Florida, 32504, United States

Location

GSK Investigational Site

Sarasota, Florida, 34239, United States

Location

GSK Investigational Site

Tampa, Florida, 33613, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30342, United States

Location

GSK Investigational Site

Austell, Georgia, 30106, United States

Location

GSK Investigational Site

Decatur, Georgia, 30033, United States

Location

GSK Investigational Site

Chicago, Illinois, 60612, United States

Location

GSK Investigational Site

Hines, Illinois, 60141-5099, United States

Location

GSK Investigational Site

North Chicago, Illinois, 60064, United States

Location

GSK Investigational Site

Peoria, Illinois, 62526, United States

Location

GSK Investigational Site

Springfield, Illinois, 62702, United States

Location

GSK Investigational Site

Newburgh, Indiana, 47630, United States

Location

GSK Investigational Site

South Bend, Indiana, 46601, United States

Location

GSK Investigational Site

Dubuque, Iowa, 52001, United States

Location

GSK Investigational Site

Waterloo, Iowa, 50702, United States

Location

GSK Investigational Site

Baton Rouge, Louisiana, 70806, United States

Location

GSK Investigational Site

Covington, Louisiana, 70433, United States

Location

GSK Investigational Site

Lafayette, Louisiana, 70503, United States

Location

GSK Investigational Site

Sunset, Louisiana, 70584, United States

Location

GSK Investigational Site

Auburn, Maine, 04210, United States

Location

GSK Investigational Site

Towson, Maryland, 21286, United States

Location

GSK Investigational Site

Detroit, Michigan, 48202, United States

Location

GSK Investigational Site

DeWitt, Michigan, 48820, United States

Location

GSK Investigational Site

Plainwell, Michigan, 49080, United States

Location

GSK Investigational Site

Richland, Michigan, 49083, United States

Location

GSK Investigational Site

Saint Joseph, Michigan, 49085, United States

Location

GSK Investigational Site

Picayune, Mississippi, 39466, United States

Location

GSK Investigational Site

Columbia, Missouri, 65211, United States

Location

GSK Investigational Site

Kansas City, Missouri, 64108, United States

Location

GSK Investigational Site

Kirkwood, Missouri, 63122, United States

Location

GSK Investigational Site

Saint Charles, Missouri, 63301, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68131, United States

Location

GSK Investigational Site

East Brunswick, New Jersey, 08816, United States

Location

GSK Investigational Site

Summit, New Jersey, 07091, United States

Location

GSK Investigational Site

Buffalo, New York, 14215-1199, United States

Location

GSK Investigational Site

Great Neck, New York, 11023, United States

Location

GSK Investigational Site

Kingston, New York, 12401, United States

Location

GSK Investigational Site

Mineola, New York, 11501, United States

Location

GSK Investigational Site

New York, New York, 10016, United States

Location

GSK Investigational Site

New York, New York, 10021, United States

Location

GSK Investigational Site

New York, New York, 10032, United States

Location

GSK Investigational Site

Elizabeth City, North Carolina, 27909, United States

Location

GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45224, United States

Location

GSK Investigational Site

Columbus, Ohio, 43212, United States

Location

GSK Investigational Site

Allentown, Pennsylvania, 18102, United States

Location

GSK Investigational Site

Allentown, Pennsylvania, 19140, United States

Location

GSK Investigational Site

Audubon, Pennsylvania, 19403, United States

Location

GSK Investigational Site

King of Prussia, Pennsylvania, 19406, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19140, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15243, United States

Location

GSK Investigational Site

Plymouth Meeting, Pennsylvania, 19462, United States

Location

GSK Investigational Site

East Providence, Rhode Island, 02914, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29406-7108, United States

Location

GSK Investigational Site

Greer, South Carolina, 29651, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Summerville, South Carolina, 29485, United States

Location

GSK Investigational Site

Clarksville, Tennessee, 37043, United States

Location

GSK Investigational Site

Morristown, Tennessee, 37813, United States

Location

GSK Investigational Site

Corsicana, Texas, 75110, United States

Location

GSK Investigational Site

Houston, Texas, 77030, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Lynchburg, Virginia, 24501, United States

Location

GSK Investigational Site

Richmond, Virginia, 23225, United States

Location

GSK Investigational Site

Schwetzingen, Baden-Wurttemberg, 68723, Germany

Location

GSK Investigational Site

Weinheim, Baden-Wurttemberg, 69469, Germany

Location

GSK Investigational Site

Bad Woerrishofen, Bavaria, 86825, Germany

Location

GSK Investigational Site

Kötzting, Bavaria, 93444, Germany

Location

GSK Investigational Site

Landsberg am Lech, Bavaria, 86899, Germany

Location

GSK Investigational Site

Munich, Bavaria, 80336, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81677, Germany

Location

GSK Investigational Site

Potsdam, Brandenburg, 14469, Germany

Location

GSK Investigational Site

Rüdersdorf, Brandenburg, 15562, Germany

Location

GSK Investigational Site

Bochum, North Rhine-Westphalia, 44787, Germany

Location

GSK Investigational Site

Bonn, North Rhine-Westphalia, 53119, Germany

Location

GSK Investigational Site

Bonn, North Rhine-Westphalia, 53123, Germany

Location

GSK Investigational Site

Düren, North Rhine-Westphalia, 52349, Germany

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GSK Investigational Site

Euskirchen, North Rhine-Westphalia, 53879, Germany

Location

GSK Investigational Site

Gelsenkirchen, North Rhine-Westphalia, 45879, Germany

Location

GSK Investigational Site

Lüdenscheid, North Rhine-Westphalia, 58509, Germany

Location

GSK Investigational Site

Solingen, North Rhine-Westphalia, 42651, Germany

Location

GSK Investigational Site

Geesthacht, Schleswig-Holstein, 21502, Germany

Location

GSK Investigational Site

Wahlstedt, Schleswig-Holstein, 23812, Germany

Location

GSK Investigational Site

Berlin, 10178, Germany

Location

GSK Investigational Site

Berlin, 10367, Germany

Location

GSK Investigational Site

Berlin, 10717, Germany

Location

GSK Investigational Site

Berlin, 10965, Germany

Location

GSK Investigational Site

Berlin, 10969, Germany

Location

GSK Investigational Site

Berlin, 13086, Germany

Location

GSK Investigational Site

Berlin, 13353, Germany

Location

GSK Investigational Site

Berlin, 13597, Germany

Location

GSK Investigational Site

Berlin, 14109, Germany

Location

GSK Investigational Site

Hamburg, 20357, Germany

Location

GSK Investigational Site

Hamburg, 22765, Germany

Location

GSK Investigational Site

Bari, Apulia, 70124, Italy

Location

GSK Investigational Site

Foggia, Apulia, 71100, Italy

Location

GSK Investigational Site

Caserta, Campania, 81100, Italy

Location

GSK Investigational Site

Eboli (SA), Campania, 84025, Italy

Location

GSK Investigational Site

Salerno, Campania, 84126, Italy

Location

GSK Investigational Site

Telese Terme (BN), Campania, 82037, Italy

Location

GSK Investigational Site

Genoa, Liguria, 16132, Italy

Location

GSK Investigational Site

Rozzano (MI), Lombardy, 20089, Italy

Location

GSK Investigational Site

Palermo, Sicily, 90146, Italy

Location

GSK Investigational Site

Pisa, Tuscany, 56124, Italy

Location

GSK Investigational Site

San Martino in Tregnano (Spoleto, PG), Umbria, 06049, Italy

Location

GSK Investigational Site

San Sisto (PG), Umbria, 06132, Italy

Location

GSK Investigational Site

Spoleto (PG), Umbria, 06049, Italy

Location

GSK Investigational Site

Cittadella (PD), Veneto, 35013, Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bacterial Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2005
• First Posted: December 1, 2005
• Study Start: November 2, 2005
• Primary Completion: November 7, 2006
• Study Completion: November 7, 2006
• Last Updated: October 12, 2017

Record last verified: 2017-10

Locations

US (79); DE (30); IT (14)