Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care (ACCESS)

• Frequency of COPD Exacerbation [ Time Frame: From 15 months pre-baseline to 24 months post-baseline. ] [ Designated as safety issue: No ]
  COPD exacerbations (moderate-severe severity), defined as a worsening of symptoms that require oral corticosteroids or antibiotics or hospitalization, or any combination of these.
  
  
• Presence and severity of cardiovascular disease. [ Time Frame: From 3 months pre-baseline to 24 months post-baseline. ] [ Designated as safety issue: No ]
  The presence and severity pre-defined cardiovascular diseases.
  
  

• Presence and severity of other comorbidities [ Time Frame: Up to 24 months post baseline. ] [ Designated as safety issue: No ]
  The presence and severity of pre-defined comorbidities (depression/anxiety, diabetes with and without target organ disease, sleep apnoea syndrome, gastroesophageal reflux, hypercholesterolemia, osteoarthritis, osteoporosis, inflammatory bowel disease, peptic ulcer, other treated comorbidities) .
  
  
• Spirometry [ Time Frame: Up to 24 months post baseline. ] [ Designated as safety issue: No ]
  Post-bronchodilator FEV1 and forced vital capacity (FVC), FEV1/FVC ratio and FEV1 % of predicted.
  
  
• Health status [ Time Frame: Up to 24 months post baseline. ] [ Designated as safety issue: No ]
  As determined by COPD Assessment Test (CAT), EuroQOL Five Dimensions Questionnaire (EQ-5D), Hospital Anxiety Depression Scale (HADS) and Epworth Sleepiness Scale (ESS), Frequency Scale for the Symptoms of Gastro-oesophageal reflux disease (FSSG).
  
  
• Dyspnoea [ Time Frame: Up to 24 months post baseline. ] [ Designated as safety issue: No ]
  As determined by the modified Medical Research Council (mMRC) scale.
  
  
• Number of Deaths [ Time Frame: up to 24 months post baseline. ] [ Designated as safety issue: No ]
  Patients who die during the study, including the reason for death, where known.
  
  
• Healthcare Utilisation [ Time Frame: Up to 24 months post baseline. ] [ Designated as safety issue: No ]
  Number of unscheduled GP contacts and Hospitalisations
  
  
• Blood Chemistry [ Time Frame: Up to 24 months post baseline. ] [ Designated as safety issue: No ]
  Including glucose; Haemoglobin A1C (HbA1c); low density lipoprotein (LDL-c), High density lipoprotein (HDL-c), Total cholesterol; triglycerides, prohormone natriuretic peptide (pro-BNP); high-sensitivity C reactive protein (hs-CRP); protein; full blood count
  
  
• Electrocardiogram [ Time Frame: Up to 24 months post baseline. ] [ Designated as safety issue: No ]
  Assessment of normal or abnormal readings. Qualitative description and QT interval.
  
  
• Bone fractures [ Time Frame: Within 12 months prior to baseline and up to 24 months post baseline ] [ Designated as safety issue: No ]
  The number and location of bone fractures.
  
  

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.