Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
prevalence, COPD, emphysema, co-morbidities, ischemic heart disease, chronic bronchitis, spirometry, burden
Brief summary
This is a cross-sectional, observational study, investigating the point prevalence of Airflow Limitation in current or former smokers with established ischemic heart disease. The study will recruit up to 3000 patients from cardiology clinics at hospitals across Europe.
Detailed description
Airflow limitation (AL) occurs in a number of respiratory diseases including asthma and COPD; in middle-aged and older patients it typically represents Chronic Obstructive Pulmonary Disease (COPD), and is associated with a high degree of co-morbidity which includes cardiovascular diseases (CVD) and risk factors such as hypertension and diabetes. COPD often goes undiagnosed, especially in patients with established coronary disease because COPD and cardiovascular diseases share a major etiological factor: smoking. This cross-sectional, observational study, investigating the prevalence of AL in current or former smokers with established ischemic heart disease, aims increase the knowledge and understanding of COPD in this patient population, and to highlight the burden of comorbid disease in these patient
Interventions
PROCEDURESpirometry
assessment of lung function by spirometry
Sponsors
GlaxoSmithKline
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects aged ≥40 years; * Current or former smokers with ≥10 pack years; * Subjects attending outpatient cardiac clinic (or equivalent) fulfilling any of the following criteria: 1. Documented history of an Ischemic event, 2. Current diagnosis of stable IHD (including history of acute Myocardial Infarction (MI) and angina pectoris) as diagnosed in accordance with ESC guidelines 3. Receiving regular therapy for IHD for \>1yr, Subjects meeting these criteria will be eligible for the study, even if they have other cardiac diseases or other co-morbidities; * Subjects willing and able to sign study consent form.
Exclusion criteria
* Subjects for whom spirometry is contraindicated; * Subjects with recent surgery or MI (within 1 month); lower respiratory tract infection or pneumothorax (within 2 months); or stroke (within 12 months); * Subjects with a pre-existing condition which, in the opinion of the investigator, would compromise the safety of the subject in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Airflow Limitation | 1 day | Prevalence of AL as defined by Forced Expired Volume in 1 second (FEV1)/Forced Volume Capacity (FVC) \< 0.70 (post bronchodilator) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| prevalence of restrictive AL | 1 day | Prevlence of restrictive AL FEV1/FVC ≥0.70 and a predicted FVC \<80% (pre bronchodilator) |
| Prevalence of AL | 1 day | Prevalence of AL as defined by FEV1 below the lower limit of normal |
| Presence of past history of AL/COPD | 1 day | prevalence of documented evidence of COPD, chronic bronchitis or emphysema |
| Severity of AL | 1 day | Severity of AL as determined by predicted FEV1 (post-bronchodilator) - mild: ≥80%, moderate: 50-80%, severe: 30-50%, very severe: \<30%, or \<50% plus chronic respiratory failure |
| Short Form 12 (SF12) | 1 day | General health status questionnaire (SF12) |
| Cardiac Health Profile (CHP) | 1 day | Health status questionnaire on burden of cardiac disease |
| Healthcare resource utilisation | within previous 12 months | Number of emergency room visits and hopsital admissions |
| COPD Assessment test™ (CAT) | 1 day | Health status questionnaire on burden of airflow limitation (CAT) |
Countries
Belgium, France, Germany, Greece, Ireland, Italy, Netherlands, Spain, Sweden
Outcome results
None listed