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.
Study Type
OBSERVATIONAL
Enrollment
341
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Valencia, Spain
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months prior to the inclusion visit
Number of subjects with COPD-related hospitalizations
Subjects with COPD-related hospitalizations will be analyzed.
Time frame: 12 months prior to the inclusion visit
Number of days of hospitalizations
The number of days of hospitalization for subjects will be analyzed.
Time frame: 12 months prior to the inclusion visit
Number of subjects with COPD-related complementary tests
Subjects with COPD-related complementary tests will be analyzed.
Time frame: 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.
Time frame: 12 months prior to the inclusion visit
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.
Time frame: 4 months (inclusion period)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 4 months (inclusion period)