Airflow Limitation in Cardiac Diseases in Europe (ALICE)

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Procedure: Spirometry

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 Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • GSK Investigational Site
• France
  • Toulouse cedex 09, France, 31059
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 13347
    • GSK Investigational Site
  • Hessen
    • Neu-Isenburg, Hessen, Germany, 63263
      • GSK Investigational Site
• Greece
  • Thessaloniki, Greece, 570 10
    • GSK Investigational Site
• Ireland
  • Dublin, Ireland, 9
    • GSK Investigational Site
  • Dublin, Ireland, 4
    • GSK Investigational Site
• Italy
  • Emilia-Romagna
    • Modena, Emilia-Romagna, Italy, 41124
      • GSK Investigational Site
  • Lombardia
    • Tradate (VA), Lombardia, Italy, 21049
      • GSK Investigational Site
• Netherlands
  • Amersfoort, Netherlands, 3818 ES
    • GSK Investigational Site
  • Sneek, Netherlands, 8601 ZK
    • GSK Investigational Site
• Spain
  • Madrid, Spain, 28046
    • GSK Investigational Site
  • Palma de Mallorca, Spain, 07010
    • GSK Investigational Site
• Sweden
  • Lund, Sweden, SE-222 21
    • GSK Investigational Site
  • Malmö, Sweden, SE-205 02
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients attending outpatient cardiology clinics with a history of Ischemic Heart Disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All; All subjects enrolled in the study	Procedure: Spirometry; assessment of lung function by spirometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Airflow Limitation	Prevalence of AL as defined by Forced Expired Volume in 1 second (FEV1)/Forced Volume Capacity (FVC) < 0.70 (post bronchodilator)	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: November 17, 2011
• First Submitted That Met QC Criteria: December 1, 2011
• First Posted (Estimate): December 5, 2011

Study Record Updates

• Last Update Posted (Estimate): February 24, 2014
• Last Update Submitted That Met QC Criteria: February 20, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: COPD; ischemic heart disease; spirometry; prevalence; co-morbidities; emphysema; chronic bronchitis; burden
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Heart Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 115398