Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with COPD | Subject has a confirmed clinical diagnosis of COPD, with or without chronic bronchitis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subject has a confirmed clinical diagnosis of COPD, with or without chronic bronchitis were included in the study
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35209 | United States | ||
| GSK Investigational Site |
Not provided
Not provided
Not provided
Not provided
| 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) |
|
| 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 |
| 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 |
| Percentage change in Global Efficacy Questionnaire scores | Up to Day 14 |
| Change from Baseline in GSK questionnaire Total and Subscales Scores | Up to Day 14 |
| Percentage change in GSK questionnaire scores | Up to Day 14 |
| Time to resolution of each domain score | Up to Day 35 |
| Time to resolution of total domain score | Up to Day 35 |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| GSK Investigational Site | Birmingham | Alabama | 35294 | United States |
| GSK Investigational Site | Hueytown | Alabama | 35023 | United States |
| GSK Investigational Site | Jasper | Alabama | 35501 | United States |
| GSK Investigational Site | Rancho Mirage | California | 92270 | United States |
| GSK Investigational Site | Riverside | California | 92506 | United States |
| GSK Investigational Site | San Diego | California | 92120 | United States |
| GSK Investigational Site | Denver | Colorado | 80206 | United States |
| GSK Investigational Site | Fort Collins | Colorado | 80528 | United States |
| GSK Investigational Site | Wheat Ridge | Colorado | 80033 | United States |
| GSK Investigational Site | Hartford | Connecticut | 06105 | United States |
| GSK Investigational Site | Hartford | Connecticut | 06106 | United States |
| GSK Investigational Site | Melbourne | Florida | 32901 | United States |
| GSK Investigational Site | Pensacola | Florida | 32503 | United States |
| GSK Investigational Site | Pensacola | Florida | 32504 | United States |
| GSK Investigational Site | Sarasota | Florida | 34239 | United States |
| GSK Investigational Site | Tampa | Florida | 33613 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Austell | Georgia | 30106 | United States |
| GSK Investigational Site | Decatur | Georgia | 30033 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | Hines | Illinois | 60141-5099 | United States |
| GSK Investigational Site | North Chicago | Illinois | 60064 | United States |
| GSK Investigational Site | Peoria | Illinois | 62526 | United States |
| GSK Investigational Site | Springfield | Illinois | 62702 | United States |
| GSK Investigational Site | Newburgh | Indiana | 47630 | United States |
| GSK Investigational Site | South Bend | Indiana | 46601 | United States |
| GSK Investigational Site | Dubuque | Iowa | 52001 | United States |
| GSK Investigational Site | Waterloo | Iowa | 50702 | United States |
| GSK Investigational Site | Baton Rouge | Louisiana | 70806 | United States |
| GSK Investigational Site | Covington | Louisiana | 70433 | United States |
| GSK Investigational Site | Lafayette | Louisiana | 70503 | United States |
| GSK Investigational Site | Sunset | Louisiana | 70584 | United States |
| GSK Investigational Site | Auburn | Maine | 04210 | United States |
| GSK Investigational Site | Towson | Maryland | 21286 | United States |
| GSK Investigational Site | Detroit | Michigan | 48202 | United States |
| GSK Investigational Site | DeWitt | Michigan | 48820 | United States |
| GSK Investigational Site | Plainwell | Michigan | 49080 | United States |
| GSK Investigational Site | Richland | Michigan | 49083 | United States |
| GSK Investigational Site | Saint Joseph | Michigan | 49085 | United States |
| GSK Investigational Site | Picayune | Mississippi | 39466 | United States |
| GSK Investigational Site | Columbia | Missouri | 65211 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64108 | United States |
| GSK Investigational Site | Kirkwood | Missouri | 63122 | United States |
| GSK Investigational Site | Saint Charles | Missouri | 63301 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68131 | United States |
| GSK Investigational Site | East Brunswick | New Jersey | 08816 | United States |
| GSK Investigational Site | Summit | New Jersey | 07091 | United States |
| GSK Investigational Site | Buffalo | New York | 14215-1199 | United States |
| GSK Investigational Site | Great Neck | New York | 11023 | United States |
| GSK Investigational Site | Kingston | New York | 12401 | United States |
| GSK Investigational Site | Mineola | New York | 11501 | United States |
| GSK Investigational Site | New York | New York | 10016 | United States |
| GSK Investigational Site | New York | New York | 10021 | United States |
| GSK Investigational Site | New York | New York | 10032 | United States |
| GSK Investigational Site | Elizabeth City | North Carolina | 27909 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45224 | United States |
| GSK Investigational Site | Columbus | Ohio | 43212 | United States |
| GSK Investigational Site | Allentown | Pennsylvania | 18102 | United States |
| GSK Investigational Site | Allentown | Pennsylvania | 19140 | United States |
| GSK Investigational Site | Audubon | Pennsylvania | 19403 | United States |
| GSK Investigational Site | King of Prussia | Pennsylvania | 19406 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19140 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15243 | United States |
| GSK Investigational Site | Plymouth Meeting | Pennsylvania | 19462 | United States |
| GSK Investigational Site | East Providence | Rhode Island | 02914 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29406-7108 | United States |
| GSK Investigational Site | Greer | South Carolina | 29651 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Summerville | South Carolina | 29485 | United States |
| GSK Investigational Site | Clarksville | Tennessee | 37043 | United States |
| GSK Investigational Site | Morristown | Tennessee | 37813 | United States |
| GSK Investigational Site | Corsicana | Texas | 75110 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Lynchburg | Virginia | 24501 | United States |
| GSK Investigational Site | Richmond | Virginia | 23225 | United States |
| GSK Investigational Site | Schwetzingen | Baden-Wurttemberg | 68723 | Germany |
| GSK Investigational Site | Weinheim | Baden-Wurttemberg | 69469 | Germany |
| GSK Investigational Site | Bad Woerrishofen | Bavaria | 86825 | Germany |
| GSK Investigational Site | Kötzting | Bavaria | 93444 | Germany |
| GSK Investigational Site | Landsberg am Lech | Bavaria | 86899 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80336 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81677 | Germany |
| GSK Investigational Site | Potsdam | Brandenburg | 14469 | Germany |
| GSK Investigational Site | Rüdersdorf | Brandenburg | 15562 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44787 | Germany |
| GSK Investigational Site | Bonn | North Rhine-Westphalia | 53119 | Germany |
| GSK Investigational Site | Bonn | North Rhine-Westphalia | 53123 | Germany |
| GSK Investigational Site | Düren | North Rhine-Westphalia | 52349 | Germany |
| GSK Investigational Site | Euskirchen | North Rhine-Westphalia | 53879 | Germany |
| GSK Investigational Site | Gelsenkirchen | North Rhine-Westphalia | 45879 | Germany |
| GSK Investigational Site | Lüdenscheid | North Rhine-Westphalia | 58509 | Germany |
| GSK Investigational Site | Solingen | North Rhine-Westphalia | 42651 | Germany |
| GSK Investigational Site | Geesthacht | Schleswig-Holstein | 21502 | Germany |
| GSK Investigational Site | Wahlstedt | Schleswig-Holstein | 23812 | Germany |
| GSK Investigational Site | Berlin | 10178 | Germany |
| GSK Investigational Site | Berlin | 10367 | Germany |
| GSK Investigational Site | Berlin | 10717 | Germany |
| GSK Investigational Site | Berlin | 10965 | Germany |
| GSK Investigational Site | Berlin | 10969 | Germany |
| GSK Investigational Site | Berlin | 13086 | Germany |
| GSK Investigational Site | Berlin | 13353 | Germany |
| GSK Investigational Site | Berlin | 13597 | Germany |
| GSK Investigational Site | Berlin | 14109 | Germany |
| GSK Investigational Site | Hamburg | 20357 | Germany |
| GSK Investigational Site | Hamburg | 22765 | Germany |
| GSK Investigational Site | Bari | Apulia | 70124 | Italy |
| GSK Investigational Site | Foggia | Apulia | 71100 | Italy |
| GSK Investigational Site | Caserta | Campania | 81100 | Italy |
| GSK Investigational Site | Eboli (SA) | Campania | 84025 | Italy |
| GSK Investigational Site | Salerno | Campania | 84126 | Italy |
| GSK Investigational Site | Telese Terme (BN) | Campania | 82037 | Italy |
| GSK Investigational Site | Genoa | Liguria | 16132 | Italy |
| GSK Investigational Site | Rozzano (MI) | Lombardy | 20089 | Italy |
| GSK Investigational Site | Palermo | Sicily | 90146 | Italy |
| GSK Investigational Site | Pisa | Tuscany | 56124 | Italy |
| GSK Investigational Site | San Martino in Tregnano (Spoleto, PG) | Umbria | 06049 | Italy |
| GSK Investigational Site | San Sisto (PG) | Umbria | 06132 | Italy |
| GSK Investigational Site | Spoleto (PG) | Umbria | 06049 | Italy |
| GSK Investigational Site | Cittadella (PD) | Veneto | 35013 | Italy |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided