Airflow Limitation in Cardiac Diseases in Europe (the ALICE study).

Completed

Conditions: COPD
Ischemic Heart Disease
10082206
10038716

Registration Number: NL-OMON35465

Lead Sponsor: GlaxoSmithKline

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 400

Inclusion Criteria

1. Subjects aged >=40 years;
2. Current or former smokers with >=10 pack years;
3. Subjects attending outpatient cardiac clinic (or equivalent) fulfilling any of the following criteria:
a. Documented history of an Ischemic event,
b. Current diagnosis of stable IHD (including history of acute Myocardial Infarction'(MI) and angina pectoris) as diagnosed in accordance with ESC guidelines
c. Receiving regular therapy for IHD for >1yr,
4. Subjects willing and able to sign study consent form.

Exclusion Criteria

1. Subjects for whom spirometry is contraindicated (e.g. with detached retina, active
tuberculosis, last trimester of pregnancy, resting pulse >120 etc);
2. Subjects with recent surgery or MI (within 1 month); lower respiratory tract infection
or pneumothorax (within 2 months); or stroke (within 12 months);
3. Subjects with a pre-existing condition which, in the opinion of the investigator, would
compromise the safety of the subject in this study.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Airflow Limitation, defined by FEV1/Forced Volume Capacity (FVC) < 0.70 (post<br /><br>bronchodilator), and measured by standardised spirometry equipment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Severity of airflow limitation, as defined by GOLD stages<br /><br>• Restrictive airflow limitation, defined by FEV1/FVC >=0.70 and a predicted FVC<br /><br><80% (pre bronchodilator)<br /><br>• Airflow limitation as defined by FEV1 below the lower limit of normal (LLN),<br /><br>as measured by standardised spirometry equipment;<br /><br>• Presence of past history of airflow limitation or COPD;<br /><br>• Health status questionnaire scores (COPD Assessment test* (CAT), SF12,<br /><br>Cardiac Health Profile);<br /><br>• Healthcare utilisation: Number of emergency room visits and hospital<br /><br>admissions in previous 12 months.</p><br>