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Airflow Limitation in Cardiac Diseases in Europe (ALICE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01485159
First received: November 17, 2011
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Pulmonary Disease, Chronic Obstructive
 Procedure: Spirometry

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Airflow Limitation in Cardiac Diseases in Europe

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Prevalence of Airflow Limitation [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Prevalence of AL as defined by Forced Expired Volume in 1 second (FEV1)/Forced Volume Capacity (FVC) < 0.70 (post bronchodilator)


Secondary Outcome Measures:
  • Severity of AL [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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

  • prevalence of restrictive AL [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Prevlence of restrictive AL FEV1/FVC ≥0.70 and a predicted FVC <80% (pre bronchodilator)

  • Prevalence of AL [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Prevalence of AL as defined by FEV1 below the lower limit of normal

  • Presence of past history of AL/COPD [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    prevalence of documented evidence of COPD, chronic bronchitis or emphysema

  • COPD Assessment test™ (CAT) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Health status questionnaire on burden of airflow limitation (CAT)

  • Short Form 12 (SF12) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    General health status questionnaire (SF12)

  • Cardiac Health Profile (CHP) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Health status questionnaire on burden of cardiac disease

  • Healthcare resource utilisation [ Time Frame: within previous 12 months ] [ Designated as safety issue: No ]
    Number of emergency room visits and hopsital admissions


Biospecimen Retention:   Samples With DNA

In patients that specifically consent, blood samples will be taken for future analysis of the genetic links between COPD and cardiovascular disease


Enrollment: 3000
Study Start Date: October 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All
All subjects enrolled in the study
 Procedure: Spirometry
assessment of lung function by 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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485159

Locations
France
GSK Investigational Site
Toulouse cedex 09, France, 31059
Greece
GSK Investigational Site
Thessaloniki, Greece, 570 10
Ireland
GSK Investigational Site
Dublin, Ireland, 4
Spain
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Palma de Mallorca, Spain, 07010
Sweden
GSK Investigational Site
Lund, Sweden, SE-222 21
GSK Investigational Site
Malmö, Sweden, SE-205 02
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01485159     History of Changes
Other Study ID Numbers: 115398
Study First Received: November 17, 2011
Last Updated: April 5, 2013
Health Authority: Germany: Ethics Commission
Ireland: Ethics Committee
France: GSK observational study
Greece: National Ethics Committee
Sweden: Datainspektionen
Sweden: Regional Ethical Review Board
Belgium: Local Medical Ethics Committee
Italy: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: Medical Ethics Review Committee (METC)
Spain: Ethics Committee
Sweden: National Board of Health and Welfare - biobanks

Keywords provided by GlaxoSmithKline:
prevalence
COPD
emphysema
co-morbidities
 ischemic heart disease
chronic bronchitis
spirometry
burden

Additional relevant MeSH terms:
Chronic Disease
Heart Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
 Disease Attributes
Pathologic Processes
Cardiovascular Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on June 17, 2013