Airflow Limitation in Cardiac Diseases in Europe

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Procedure: Spirometry

• Registration Number: NCT01485159
• Lead Sponsor: GlaxoSmithKline

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

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2011-12-01
• Study First Posted: 2011-12-05
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-20
• Last Update Posted: 2014-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All	Spirometry	All subjects enrolled in the study

Primary Outcome Measures

Name	Time	Method
Prevalence of Airflow Limitation	1 day	Prevalence of AL as defined by Forced Expired Volume in 1 second (FEV1)/Forced Volume Capacity (FVC) \< 0.70 (post bronchodilator)

Secondary Outcome Measures

Name	Time	Method
Severity of AL	1 day	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
Presence of past history of AL/COPD	1 day	prevalence of documented evidence of COPD, chronic bronchitis or emphysema
Healthcare resource utilisation	within previous 12 months	Number of emergency room visits and hopsital admissions
prevalence of restrictive AL	1 day	Prevlence of restrictive AL FEV1/FVC ≥0.70 and a predicted FVC \<80% (pre bronchodilator)
Prevalence of AL	1 day	Prevalence of AL as defined by FEV1 below the lower limit of normal
COPD Assessment test™ (CAT)	1 day	Health status questionnaire on burden of airflow limitation (CAT)
Short Form 12 (SF12)	1 day	General health status questionnaire (SF12)
Cardiac Health Profile (CHP)	1 day	Health status questionnaire on burden of cardiac disease

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇪 Malmö, Sweden