Clinical trial NCT01485159: Airflow Limitation in Cardiac Diseases in Europe
Official title: Airflow Limitation in Cardiac Diseases in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: prevalence
COPD
emphysema
co-morbidities
ischemic heart disease
chronic bronchitis
spirometry
burden
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-12-05
Enrollment: 3000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients attending outpatient cardiology clinics with a history of Ischemic Heart Disease

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 to 3000 patients from cardiology clinics at hospitals across Europe.

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), 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

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of Airflow Limitation
timeFrame: 1 day
Secondary outcomes:
measure: Severity of AL
timeFrame: 1 day
measure: prevalence of restrictive AL
timeFrame: 1 day
measure: Prevalence of AL
timeFrame: 1 day
measure: Presence of past history of AL/COPD
timeFrame: 1 day
measure: COPD Assessment test™ (CAT)
timeFrame: 1 day
measure: Short Form 12 (SF12)
timeFrame: 1 day
measure: Cardiac Health Profile (CHP)
timeFrame: 1 day
measure: Healthcare resource utilisation
timeFrame: within previous 12 months
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Toulouse cedex 09
country: France
facility: GSK Investigational Site
city: Neu-Isenburg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Dublin
country: Ireland
facility: GSK Investigational Site
city: Dublin
country: Ireland
facility: GSK Investigational Site
city: Modena
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Tradate (VA)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Amersfoort
country: Netherlands
facility: GSK Investigational Site
city: Sneek
country: Netherlands
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Lund
country: Sweden
facility: GSK Investigational Site
city: Malmö
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Franssen FM, Soriano JB, Roche N, Bloomfield PH, Brusselle G, Fabbri LM, Garcia-Rio F, Kearney MT, Kwon N, Lundback B, Rabe KF, Raillard A, Muellerova H, Cockcroft JR. Lung Function Abnormalities in Smokers with Ischemic Heart Disease. Am J Respir Crit Care Med. 2016 Sep 1;194(5):568-76. doi: 10.1164/rccm.201512-2480OC.