Airflow Limitation in Cardiac Diseases in Europe

Pulmonary Disease, Chronic Obstructive Clinical Trial

— ALICE  

Official title:

Airflow Limitation in Cardiac Diseases in Europe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485159
• Other study ID #: 115398
• Status: Completed
• Phase: N/A
• First received: November 17, 2011
• Last updated: February 20, 2014
• Start date: October 2011
• Est. completion date: June 2012

Study information

• Verified date: February 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionIreland: Ethics CommitteeFrance: GSK observational studyGreece: National Ethics CommitteeSweden: DatainspektionenSweden: Regional Ethical Review BoardBelgium: Local Medical Ethics CommitteeItaly: Ethics CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Netherlands: Medical Ethics Review Committee (METC)Spain: Ethics CommitteeSweden: National Board of Health and Welfare - biobanks
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Disease
• Heart Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Spirometry
assessment of lung function by spirometry

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Gent
France	GSK Investigational Site	Toulouse cedex 09
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Neu-Isenburg	Hessen
Greece	GSK Investigational Site	Thessaloniki
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
Italy	GSK Investigational Site	Modena	Emilia-Romagna
Italy	GSK Investigational Site	Tradate (VA)	Lombardia
Netherlands	GSK Investigational Site	Amersfoort
Netherlands	GSK Investigational Site	Sneek
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Palma de Mallorca
Sweden	GSK Investigational Site	Lund
Sweden	GSK Investigational Site	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Greece,  Ireland,  Italy,  Netherlands,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	prevalence of restrictive AL	Prevlence of restrictive AL FEV1/FVC =0.70 and a predicted FVC <80% (pre bronchodilator)	1 day	No
Secondary	Prevalence of AL	Prevalence of AL as defined by FEV1 below the lower limit of normal	1 day	No
Secondary	Presence of past history of AL/COPD	prevalence of documented evidence of COPD, chronic bronchitis or emphysema	1 day	No
Secondary	COPD Assessment test™ (CAT)	Health status questionnaire on burden of airflow limitation (CAT)	1 day	No
Secondary	Short Form 12 (SF12)	General health status questionnaire (SF12)	1 day	No
Secondary	Cardiac Health Profile (CHP)	Health status questionnaire on burden of cardiac disease	1 day	No
Secondary	Healthcare resource utilisation	Number of emergency room visits and hopsital admissions	within previous 12 months	No