An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 15 sites in 9 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2014-02-24.
Sponsored by GlaxoSmithKline · Observational
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
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 3,000 is above the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients attending outpatient cardiology clinics with a history of Ischemic Heart Disease
Subjects attending outpatient cardiac clinic (or equivalent) fulfilling any of the following criteria:
Exclusion Criteria:
All subjects enrolled in the study
Procedure: Spirometry
assessment of lung function by spirometry
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
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
Healthcare resource utilisation
Number of emergency room visits and hopsital admissions
Time frame: within previous 12 months
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
GlaxoSmithKline