Airflow Limitation in Cardiac Diseases in Europe (ALICE)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Procedure: Spirometry

Study type: Observational

Funder types: Industry

Identifiers

NCT01485159

115398

Details and patient eligibility

About

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.

Full 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

Enrollment: 3,000 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,000 participants in 1 patient group

All

Description:

All subjects enrolled in the study

Treatment:

Procedure: Spirometry