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| Name | Class |
|---|---|
| Oblikue Consulting | UNKNOWN |
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This observational study is designed to more specifically describe the burden of the disease and the use of healthcare resources of subjects with eosinophilic COPD that may be eligible in the future for a biologic treatment. Subjects who attend a routine follow-up visit and fulfill the inclusion/exclusion criteria defined provide a signed informed consent will be invited by the investigator to participate in this study. Subjects will be recruited in hospital Pulmonology Services across Spain. It is planned to include approximately 20 centers. To select the final participating centers, a feasibility study has been carried out in approximately 50 potential participating centers. It has been estimated that each investigator will include 18 subjects during the 4-month inclusion period. Total 354 subjects will be required: 250 subjects with an eosinophil level >=150 cells per microliter and 104 subjects with an eosinophil level <150 cells per microliter. The study inclusion period will be 4 months (expected to be from November 2017 to March 2018) and the retrospective data collection period will be 12 months prior to the inclusion visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with COPD | Subjects with a COPD diagnosis confirmed with a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital capacity <70% recorded at any time in the medical record who have a qualifying peripheral blood eosinophil test recorded in the 3 months prior to the inclusion visit attend to a routine follow-up visit during the inclusion period, fulfill the inclusion/exclusion criteria and provide informed consent to participate, will be included in this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects requiring COPD maintenance treatment and rescue medication | Subjects currently exposed to inhaled triple maintenance therapy, defined as at least one overlapping prescription of an inhaled corticosteroid (ICS) with a long-acting beta2-agonist (LABA) and with a long-acting muscarinic antagonist (LAMA) in 2 or 3 inhaler devices, without more than 30 days of separation between prescriptions along with rescue medication use will be analyzed. | 12 months prior to the inclusion visit |
| Number of subjects with moderate and severe exacerbations | Subjects who have experienced >=2 moderate exacerbations or >=1 severe exacerbation in the 12 months prior to the inclusion visit. Moderate exacerbation is defined as an exacerbation requiring antibiotics and/or oral corticosteroids or requiring an emergency visit <24 hours (without hospitalization). Severe exacerbation is defined as an exacerbation requiring hospitalization. | 12 months prior to the inclusion visit |
| Number of subjects with COPD-related scheduled and unscheduled primary and secondary care visits | Subjects with COPD-related scheduled and unscheduled primary and secondary care visits will be analyzed. | 12 months prior to the inclusion visit |
| Number of subjects with COPD-related emergency visits to primary care and hospital | Subjects with COPD-related emergency visits to primary care and hospital will be analyzed. | 12 months prior to the inclusion visit |
| Number of subjects with COPD-related hospitalizations | Subjects with COPD-related hospitalizations will be analyzed. | 12 months prior to the inclusion visit |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects age as a measure of sociodemographic characteristics | Age will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in the study. A threshold of >=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis. | 4 months (inclusion period) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who attend a routine follow-up visit and who fulfill inclusion/exclusion criteria will be invited by the investigator to participate in the study. The study inclusion period will be four months (from November 2017 to March 2018) and the retrospective data collection period will be 12 months prior to the inclusion visit.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| GSK Clinical Trials | GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Barcelona | 08036 | Spain | |||
| GSK Investigational Site |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Number of days of hospitalizations |
The number of days of hospitalization for subjects will be analyzed. |
| 12 months prior to the inclusion visit |
| Number of subjects with COPD-related complementary tests | Subjects with COPD-related complementary tests will be analyzed. | 12 months prior to the inclusion visit |
| Number of subjects with COPD-related days-off work | Subjects with COPD-related days-off work will be analyzed. | 12 months prior to the inclusion visit |
| Number of subjects with different gender | Gender will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in the study. A threshold of >=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis. | 4 months (inclusion period) |
| Number of subjects with different sociodemographic variables | Subjects with different educational level, employment status, monthly net income will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in the study A threshold of >=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis. | 4 months (inclusion period) |
| Number of subjects with abnormal clinical variables | Clinical variables comprising weight, height, body mass index (self-calculated), smoking history, Charlson comorbidity index, diagnosis of asthma will be assessed for abnormalities. A threshold of >=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis. | 4 months (inclusion period) |
| Number of subjects with abnormal COPD related variables | COPD variables comprising COPD diagnosis date, pulmonary function with bronchodilator test, modified Medical Research Council (mMRC) dyspnea scale, clinical phenotypes according to Spanish COPD Clinical Guidelines (GesEPOC) criteria will be assessed for abnormalities. A threshold of >=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis. | 12 months prior to the inclusion visit |
| Number of subjects with abnormal blood cell count | Peripheral blood eosinophil count, peripheral blood neutrophil count, peripheral blood leukocyte count, fibrinogen and red cell distribution width will be assessed for abnormalities. | 12 months prior to the inclusion visit |
| COPD Assessment Test (CAT) score as a measure of Health Related Quality of Life (HRQoL) | The CAT questionnaire is a COPD-specific questionnaire that measures the impact of the disease on HRQoL and allows symptoms to be described. It consists of 8 items, which yield a score range from 0 to 40, 0 representing the lowest impact on HRQoL and 40 the maximum impact. | 4 months (inclusion period) |
| EuroQOL five dimensions five level (EQ-5D-5L) score as a measure of HRQoL | The EQ-5D-5L is a preference-based generic HRQoL questionnaire, consisting on five health dimensions (mobility, personal care, daily activities, pain/discomfort and anxiety/depression), divided in five levels of severity (no problems, slight problems, moderate problems, severe problems and extreme problems). It included also a visual analogue scale (VAS) in which respondents are asked to evaluate their overall health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). | 4 months (inclusion period) |
| Madrid |
| 28040 |
| Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Valencia | 46017 | Spain |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |