Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care
Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care
This is a prospective, observational, non-drug interventional, non-randomized study to compare the rate of moderate-severe COPD exacerbations in patients of all Chronic Obstructive Pulmonary Disease (COPD) severities with and without cardiovascular diseases. A total study population of 3330 subjects will be recruited by general practitioners (GPs) and assessed over a 27 month time frame.
COPD is a leading cause of morbidity and mortality worldwide. Comorbid diseases are an important factor in the prognosis and functional capabilities of COPD patients. There is a relationship between cardiac comorbidity and COPD exacerbation frequency within COPD patients. The main objective of this study is to compare the rate of moderate-severe COPD exacerbations in patients of all COPD severities with and without cardiovascular diseases. Secondary objectives will characterize the prevalence, severity and incidence over time of comorbidities and explore the relationships between comorbidities and rate of COPD exacerbations, force expiratory volume in 1 second (FEV1) decline and quality of life. This will be a prospective, observational, non-drug interventional, non-randomized study that will be carried out in up to 8 European countries. All patients will be enrolled by GP outpatient clinics and data will be collected over 4 visits (screening [-3 months], baseline, 12 months post baseline 24 months post baseline) and, additionally by 6 telephone calls (at 3, 6, 9, 15, 18 and 21 months post baseline). The study population will consist of 3330 evaluable patients with diagnosed COPD of any severity grade with and without comorbidities. Subjective and objective data on pre-defined comorbidities will be collected and analyzed.
Inclusion Criteria:
Exclusion Criteria:
Chollet, 49300, France
Grandchamps, 56390, France
La Fôret Sur Sèvres, 79380, France
Bad Woerrishofen, Bavaria 86825, Germany
Benidor / Alicante, 03503, Spain
Canet de Mar - Barcelona, 08360, Spain
Colloto - Oviedo, 33010, Spain
Cornellá de Llobregat-Barcelona, 08940, Spain
Culleredo - La Coruña, 15670, Spain
El Puerto de Santa María-Cádiz, 11500, Spain
Fuenlabrada / Madrid, 28943, Spain
Gijón. Asturias., 33213, Spain
Güeñes - Vizcaya, 48830, Spain
Hostalric - Gerona, 17450, Spain
Les Franqueses Del Vallés - Barcelona, 08530, Spain
Mataró. Barcelona., 08302, Spain
Petrer/Alicante, 03610, Spain
Portugalete - Vizcaya, 48920, Spain
Santa Coloma de Gramanet - Barcelona, 08924, Spain