Spirometry
Procedureassessment of lung function by spirometry
NCT Number: NCT01485159
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.
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Notify Me40 year and older
All sexes
Observational
GSK Investigational Site, Ghent, Belgium
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
assessment of lung function by spirometry
Time frame: 1 day
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
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
Prevlence of restrictive AL FEV1/FVC ≥0.70 and a predicted FVC <80% (pre bronchodilator)
Time frame: 1 day
Prevalence of AL as defined by FEV1 below the lower limit of normal
Time frame: 1 day
prevalence of documented evidence of COPD, chronic bronchitis or emphysema
Time frame: 1 day
Health status questionnaire on burden of airflow limitation (CAT)
Time frame: 1 day
General health status questionnaire (SF12)
Time frame: 1 day
Health status questionnaire on burden of cardiac disease
Time frame: within previous 12 months
Number of emergency room visits and hopsital admissions
GlaxoSmithKline
Industry
Acronym: ALICE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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