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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Procedure: Spirometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged ≥ 40 years An established clinical history of COPD for a minimum of 12 months, of any severity. FEV1/FVC post-bronchodilator ratio < 0.70 (within the last 12 months, or confirmed at the screening visit [or 4 weeks after the screening visit if patient's COPD is not stable]). Current or ex-smokers with a smoking history of at least 10 pack-years A signed and dated written informed consent is obtained prior to participation Exclusion Criteria: In the opinion of the investigator, there is a current primary diagnosis of asthma (patients with a primary diagnosis of COPD but who also have asthma may be included) A diagnosis of fibrosis or asbestosis Diagnosis of cancer - current or within the last 5 years (patients in remission for ≥ 5 years may be included). Patients diagnosed with cancer during the study will be withdrawn Diagnosis of clinically significant bronchiectasis Subjects who are concurrently participating in any clinical study or who have received any investigational drugs within 4 weeks of baseline, or who will start any during the study period. Unable to or unwilling to conform with the study requirements including completion of the health status questionnaires Females who are pregnant or lactating.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All<br>All subjects enrolled in the study | Procedure: Spirometry<br>* Assessment of lung function by spirometry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of COPD Exacerbation | COPD exacerbations (moderate-severe severity), defined as a worsening of symptoms that require oral corticosteroids or antibiotics or hospitalization, or any combination of these. | From 15 months pre-baseline to 24 months post-baseline. | 
| Presence and severity of cardiovascular disease. | The presence and severity pre-defined cardiovascular diseases. | From 3 months pre-baseline to 24 months post-baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence and severity of other comorbidities | 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) . | Up to 24 months post baseline. | 
| Spirometry | Post-bronchodilator FEV1 and forced vital capacity (FVC), FEV1/FVC ratio and FEV1 % of predicted. | Up to 24 months post baseline. | 
| Health status | 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). | Up to 24 months post baseline. | 
| Dyspnoea | As determined by the modified Medical Research Council (mMRC) scale. | Up to 24 months post baseline. | 
| Number of Deaths | Patients who die during the study, including the reason for death, where known. | up to 24 months post baseline. | 
| Healthcare Utilisation | Number of unscheduled GP contacts and Hospitalisations | Up to 24 months post baseline. | 
| Blood Chemistry | 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 | Up to 24 months post baseline. | 
| Electrocardiogram | Assessment of normal or abnormal readings. Qualitative description and QT interval. | Up to 24 months post baseline. | 
| Bone fractures | The number and location of bone fractures. | Within 12 months prior to baseline and up to 24 months post baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, exacerbation, comorbidities, lung function, burden, chronic bronchitis, emphysema, prevalence, cardiovascular disease