Airflow Limitation in Cardiac Diseases in Europe

GlaxoSmithKline3,000 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

SpirometryPROCEDURE

assessment of lung function by spirometry

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (15)

GSK Investigational Site

Ghent, Belgium

GSK Investigational Site

Toulouse, France

GSK Investigational Site

Neu-Isenburg, Hesse, Germany

Outcomes

Primary Outcomes

Prevalence of Airflow Limitation

Prevalence of AL as defined by Forced Expired Volume in 1 second (FEV1)/Forced Volume Capacity (FVC) \< 0.70 (post bronchodilator)

Time frame: 1 day

Secondary Outcomes

Severity of AL

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

Time frame: 1 day

prevalence of restrictive AL

Prevlence of restrictive AL FEV1/FVC ≥0.70 and a predicted FVC \<80% (pre bronchodilator)

Time frame: 1 day

Prevalence of AL

Prevalence of AL as defined by FEV1 below the lower limit of normal

Time frame: 1 day

Presence of past history of AL/COPD

prevalence of documented evidence of COPD, chronic bronchitis or emphysema

Time frame: 1 day

COPD Assessment test™ (CAT)

Health status questionnaire on burden of airflow limitation (CAT)

Time frame: 1 day

Short Form 12 (SF12)

General health status questionnaire (SF12)

Time frame: 1 day

Cardiac Health Profile (CHP)

Health status questionnaire on burden of cardiac disease

Time frame: 1 day

Data from ClinicalTrials.gov

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