Status:
COMPLETED
Airflow Limitation in Cardiac Diseases in Europe
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Brief Summary
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...
Detailed 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), an...
Eligibility Criteria
Inclusion
- 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:
- Documented history of an Ischemic event,
- Current diagnosis of stable IHD (including history of acute Myocardial Infarction (MI) and angina pectoris) as diagnosed in accordance with ESC guidelines
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT01485159
Start Date
October 1 2011
End Date
June 1 2012
Last Update
February 24 2014
Active Locations (15)
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1
GSK Investigational Site
Ghent, Belgium, 9000
2
GSK Investigational Site
Toulouse, France, 31059
3
GSK Investigational Site
Neu-Isenburg, Hesse, Germany, 63263
4
GSK Investigational Site
Berlin, State of Berlin, Germany, 13347