Cardiovascular Diseases, Cardiovascular Events, Comorbid Chronic Lung Disease on Heart Failure, COPD, COPD Exacerbation Acute, COPD Prevalance, Mortality
Conditions
Keywords
COPD, AECOPD, Mortality in AECOPD, COPD mortality risk factors, COPD prevalence, lung function, emphysema, chronic bronchitis, COPD hospitalization, heart failure, cardiovascular mortality, Bronchodilators, COPD therapy, triple therapy
Brief summary
Chronic obstructive pulmonary disease (COPD) is a treatable but debilitating medical condition associated with persistent symptoms and chronic airflow obstruction. Despite the availability of multiple therapeutic options, COPD is the third leading cause of death worldwide and has a substantial socioeconomic impact. The present real life study is aimed at describing the clinical and functional characteristics, treatment patterns, impact of exacerbations and comorbidities and their association with mortality in a large cohort of Italian patients with COPD.
Detailed description
The temporal relationship of observation period to time of participant enrollment will be both retrospective and prospective. A digital dataset will be shared with the participating centers. The following variables, if available, will be collected. Demographic and clinical variables: * Age, sex, height, weight, BMI, waist circumference. * Pneumonia episodes in the last 12 months and number of hospitalizations for pneumonia. * Number of pulmonary rehabilitation cycles performed * Vaccination status (Flu, SARS-CoV-2, pneumococcus, human respiratory syncytial virus, herpes zoster) COPD characteristics: * Date of COPD diagnosis. * COPD exacerbations in the year before the index date (mild, moderate, severe exacerbations), hospitalizations and/or access to ICU. * Type, dosages and duration of antibiotic and systemic corticosteroid treatments during exacerbations. * Respiratory symptoms evaluated with mMRC and CAT * Frequency and purulence of sputum, cough frequency * Inhaled bronchodilator/corticosteroid therapy and type of device used, any treatment changes at index date or during follow up. * Mucolytic agents (active molecules and dosage) * Chronic use of azithromycin * Therapy with roflumilast. * Biological therapies (type of active molecules, duration, switch). * Long-term oxygen therapy (FiO2, average flow), presence of tracheostomy and any invasive or non-invasive ventilatory support Comorbidities: * Concomitant respiratory diseases, history of exposure to risk factors, smoking history (active, former and non-smoker). * Cardiovascular comorbidities and complications in the last 12 months before index date and during follow up * Cardioactive pharmacological therapies * Charlson score * Other comorbidities Biological and functional variables: * Blood tests (RBC, Hb, hematocrit, MCV, PLT, WBC differential, CRP, glycemia, creatinine, uremia, NT-proBNP, cholesterol). * Cardiopulmonary exercise test. The variables collected will include: VO2max, WR max, HRmax, VE max, VEmax, VE/VO2 ratio, PET CO2, O2 pulse, anaerobic threshold, A-a gradient. All values will be collected as absolute and as percentage of predicted values. * Nocturnal oximetry: FiO2, T-90, mean SpO2, ODI. * Polysomnography: type of support (e.g. CPAP or NIMV), FiO2, apnea-hypopnea index (AHI; obstructive, central, and mixed type), AI, oxygen desaturation index (ODI), T-90, Cheyne-Stokes respiration, snoring and body position during the exam. * 6 minutes walking test: FiO2, distance walked in meters and predicted value, SpO2 at the beginning and end of the test, desaturation, if SpO2<90, modified Borg dyspnea score at the beginning and end of the test. * Gas exchange: SpO2, FiO2, Blood Gas Analysis (pH, PaO2, PaCO2, HCO3-, A-a gradient, FiO2, PaO2/FiO2) * Lung function test pre- and post-bronchodilator: FVC, FEV1, FEV1/FVC, FEF 25-75, VC, IC, FEV1/VC. All values will be collected as absolute values, ratio and percentage of predicted values. * Body plethysmography pre- and post-bronchodilator: TGV, RV, TLC, RV/TLC, IC/TLC, sRAW. All values will be collected as absolute values, ratio and percentage of predicted values * Diffusion capacity of the lung for carbon monoxide: DLCO, KCO, VA, TLC/VA * Fractional exhaled nitric oxide * Chest imaging: radiography or CT scan, presence of emphysema (panlobular or centrolobular), bronchiectasis or interstitial lung disease. * Ecocardiography: ejection fraction, pathological signs, PAPs, left ventricular hypertrophy and left atrial, right ventricular or left ventricular enlargement. * Coronary angiography: if pathological for stenosis and number of involved vessels, PTCA or CABG. All these items will be also valued during the follow up period, with an emphasis on COPD exacerbations and date and cause of death.
Interventions
Pharmacological and non pharmacological treatments will be assessed and monitored during the retrospective and prospective phase, and will include: * bronchodilators, inhaled steroids and their combinations * mucolytics * biologic therapies for COPD * roflumilast * pulmonary rehabilitation
Sponsors
University of Milan
University of Genova
University of Pavia
Azienda Ospedaliera Universitaria Integrata Verona
University Magna Graecia
University of Rome Tor Vergata
Università degli Studi di Sassari
University of Palermo
University of Turin, Italy
University Hospital Verona, Italy
University Hospital of Ferrara
Societa Italiana di Pneumologia
Italian Association of Hospital Pneumologists
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• established diagnosis of COPD (defined as age ≥ 40 years old, smoking history ≤ 20 pack years, postbronchodilator forced expiratory volume in one second to slow vital capacity ratio (FEV1/VC) ≤ the lower limit of normal (LLN) criteria.
Exclusion criteria
* Presence of current clinically significant asthma * Diagnosis or clinically significant alternative respiratory diseases (such as interstitial lung disease or bronchiectasis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | From index date (registry inclusion) until the date of death from any cause, assessed up to 120 months | Annual all-cause mortality rate |
| Burden of moderate and severe COPD acute exacerbations | From index date (registry inclusion) until the date of first event of moderate or severe exacerbation, and any following event of moderate or severe exacerbation, or patient's death, whichever comes first, assessed up to 120 months | Incidence and annual rate of moderate and/or severe exacerbations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular mortality | From index date (registry inclusion) until the date of death provoked by a cardiovascular event, assessed up to 120 months | Annual death rate for cardiovascular events |
| Cardiovascular comorbidities | At index date (registry inclusion) comorbidities will be registered and updated at every new visit until patient's death | prevalence of cardiovascular comorbidities and their relationship with lung function, respiratory symptoms, moderate and severe exacerbations, mortality |
| Cardiovascular events | From index date (registry inclusion) until the date of any cardiovascular event or cardiovascular death, whichever comes first, assessed up to 120 months | Incidence and prevalence of cardiovascular events (overall and severe) and their relationship with COPD acute exacerbations |
| Lung function decline | From index date (registry inclusion) until the date of the first lung function test, and any following available lung function assessment, or the date of patient's death, whichever comes first, assessed up to 120 months | trend in lung function indexes (spirometric, plethysmographic, DLCO) over time |
| Eosinophil count | From index date (registry inclusion) until the date of first available eosinophil count, and any following point in time with available eosinophil count updates, or patients' death, whichever comes first, assessed up to 120 months | Describe eosinophil count in absolute and % of leukocyte formula in the study population, its trend over time and its relationship with lung function, lung function decline, COPD exacerbations, cardiovascular events and mortality |
| Evaluation of the pharmacological treatment at baseline and treatment switches | From index date (registry inclusion) until the date of first available inhaled treatment switch, and every point in time the patient changes inhaled treatment, or the patient's death from any cause, whichever comes first, assessed up to 120 months | Prevalence of type of inhaled therapy over time from index date until end of study |
Countries
Italy
Outcome results
None listed