Pulmonary Disease, Chronic ObstructiveALICENCT01485159
Airflow Limitation in Cardiac Diseases in Europe
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 15 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Spirometry
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 15 sitesin 9 countries
- Study dates
- Oct 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending outpatient cardiology clinics with a history of Ischemic Heart Disease
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
15 sites in 9 countries.
15 sites in 9 countries
Germany2 sites
GSK Investigational Site
Berlin, State of Berlin, 13347
GSK Investigational Site
Neu-Isenburg, Hesse, 63263
Ireland2 sites
GSK Investigational Site
Dublin, 4
GSK Investigational Site
Dublin, 9
Italy2 sites
GSK Investigational Site
Modena, Emilia-Romagna, 41124
GSK Investigational Site
Tradate (VA), Lombardy, 21049
Netherlands2 sites
GSK Investigational Site
Amersfoort, 3818 ES
GSK Investigational Site
Sneek, 8601 ZK
Spain2 sites
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Palma de Mallorca, 07010
Sweden2 sites
GSK Investigational Site
Lund, SE-222 21
GSK Investigational Site
Malmö, SE-205 02
About this study
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.
Read the 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
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Spirometry
- Keywords
- prevalence, COPD, emphysema, co-morbidities, ischemic heart disease, chronic bronchitis, spirometry, burden
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Myocardial Ischemia, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirometryProcedure or surgery
assessment of lung function by spirometry
| Study group | Role | What they receive |
|---|---|---|
| All | All subjects enrolled in the study Receives: Procedure: Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 day
Secondary outcomes (8)
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
Measured: 1 day
prevalence of restrictive AL
Prevlence of restrictive AL FEV1/FVC ≥0.70 and a predicted FVC <80% (pre bronchodilator)
Measured: 1 day
Prevalence of AL
Prevalence of AL as defined by FEV1 below the lower limit of normal
Measured: 1 day
Presence of past history of AL/COPD
prevalence of documented evidence of COPD, chronic bronchitis or emphysema
Measured: 1 day
COPD Assessment test™ (CAT)
Health status questionnaire on burden of airflow limitation (CAT)
Measured: 1 day
Short Form 12 (SF12)
General health status questionnaire (SF12)
Measured: 1 day
Cardiac Health Profile (CHP)
Health status questionnaire on burden of cardiac disease
Measured: 1 day
Healthcare resource utilisation
Number of emergency room visits and hopsital admissions
Measured: within previous 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485159
- Sponsor's protocol ID
- 115398
- Acronym
- ALICE
- Status last verified
- Feb 2014
- First submitted
- 17 Nov 2011
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27442601
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airflow Limitation in Cardiac Diseases in Europe
- ClinicalTrials.gov ID
- NCT01485159
- Acronym / sponsor ID
- ALICE / 115398
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- prevalence, COPD, emphysema, co-morbidities, ischemic heart disease, chronic bronchitis, spirometry, burden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All | – | Procedure: SpirometryAll subjects enrolled in the study |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending outpatient cardiology clinics with a history of Ischemic Heart Disease
Key inclusion criteria (7 listed)
- 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:
- Subjects willing and able to sign study consent form.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spirometryassessment of lung function by spirometry | Procedure or surgery | All |
Primary outcome
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)
8 secondary outcomes
Severity of AL
Time frame: 1 day
prevalence of restrictive AL
Time frame: 1 day
Prevalence of AL
Time frame: 1 day
Presence of past history of AL/COPD
Time frame: 1 day
COPD Assessment test™ (CAT)
Time frame: 1 day
Short Form 12 (SF12)
Time frame: 1 day
Cardiac Health Profile (CHP)
Time frame: 1 day
Healthcare resource utilisation
Time frame: within previous 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
- Derived from this study: PubMed 27442601Franssen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
15 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 15 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, Ireland, Italy, Netherlands, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Airflow Limitation (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01485159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2014.