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Completed

NCT Number: NCT01485159

Airflow Limitation in Cardiac Diseases in Europe

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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 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

Treatment and study plan

Spirometry

Procedure

assessment of lung function by spirometry

Primary outcomes

  1. Prevalence of Airflow Limitation

    Time frame: 1 day

    Prevalence of AL as defined by Forced Expired Volume in 1 second (FEV1)/Forced Volume Capacity (FVC) < 0.70 (post bronchodilator)

Secondary outcomes

  1. Severity of AL

    Time frame: 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

  2. prevalence of restrictive AL

    Time frame: 1 day

    Prevlence of restrictive AL FEV1/FVC ≥0.70 and a predicted FVC <80% (pre bronchodilator)

  3. Prevalence of AL

    Time frame: 1 day

    Prevalence of AL as defined by FEV1 below the lower limit of normal

  4. Presence of past history of AL/COPD

    Time frame: 1 day

    prevalence of documented evidence of COPD, chronic bronchitis or emphysema

  5. COPD Assessment test™ (CAT)

    Time frame: 1 day

    Health status questionnaire on burden of airflow limitation (CAT)

  6. Short Form 12 (SF12)

    Time frame: 1 day

    General health status questionnaire (SF12)

  7. Cardiac Health Profile (CHP)

    Time frame: 1 day

    Health status questionnaire on burden of cardiac disease

  8. Healthcare resource utilisation

    Time frame: within previous 12 months

    Number of emergency room visits and hopsital admissions

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Acronym: ALICE

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 5, 2011
Registry last updated
Feb 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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