An observational study in COPD, COPD Exacerbation Acute and Comorbid Chronic Lung Disease on Heart Failure, sponsored by University of Milan. Enrolling by invitation at 1 site in Italy. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by University of Milan · Observational
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.
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:
COPD characteristics:
Comorbidities:
Biological and functional variables:
All these items will be also valued during the follow up period, with an emphasis on COPD exacerbations and date and cause of death.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →University of Milan is the lead sponsor of 183 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients with functionally confirmed COPD and a track medical record in the 12 months before enrollment
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients with a functionally confirmed diagnosis of COPD
Other: Pharmacological treatment
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
All pharmacological and non pharmacological treatments for COPD will be assessed and monitored during the retrospective and prospective phase of the study, and will include: * inhaled bronchodilators (long term beta-2 agonists and cholinergic antagonists), inhaled corticosteroids and their combinations * mucolytics * biologics for COPD (monoclonal antibodies) * roflumilast * chronic oral azythromicin * pulmonary rehabilitation * oxygen therapy * non invasive/invasive ventilation
All cause mortality
Annual all-cause mortality rate
Time frame: From index date (registry inclusion) until the date of death from any cause, assessed up to 120 months
Burden of moderate and severe COPD acute exacerbations
Incidence and annual rate of moderate and/or severe exacerbations
Time frame: 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
Cardiovascular mortality
Annual death rate for cardiovascular events
Time frame: From index date (registry inclusion) until the date of death provoked by a cardiovascular event, assessed up to 120 months
Cardiovascular comorbidities
prevalence of cardiovascular comorbidities and their relationship with lung function, respiratory symptoms, moderate and severe exacerbations, mortality
Time frame: At index date (registry inclusion) comorbidities will be registered and updated at every new visit until patient's death
Cardiovascular events
Incidence and prevalence of cardiovascular events (overall and severe) and their relationship with COPD acute exacerbations
Time frame: From index date (registry inclusion) until the date of any cardiovascular event or cardiovascular death, whichever comes first, assessed up to 120 months
Lung function decline
trend in lung function indexes (spirometric, plethysmographic, DLCO) over time
Time frame: 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
Eosinophil count
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
Time frame: 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
Evaluation of the pharmacological treatment at baseline and treatment switches
Prevalence of type of inhaled therapy over time from index date until end of study
Time frame: 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
Exacerbation etiology
Describe the frequency and type of viral or bacterial isolates during acute exacerbations, and their relationship with lung function, comorbidities and exacerbation severity
Time frame: From index date (registry inclusion) until the date of the first available acute exacerbation of any severity, and any following event of modand any following exacerbation event date, or patient 's death, whichever comes first, assessed up to 120 months
Corticosteroid treatment during COPD exacerbation
Describe the frequency and dosage of systemic and oral corticosteroids, treatment duration and their relationship with COPD severity, comorbidities, exacerbation severity and exacerbation etiology
Time frame: From index date (registry inclusion) until the date of first exacerbation of any severity, and any following event of moderate or severe exacerbation, or patient's death, whichever comes first, assessed up to 120 months.
Antibiotic treatments during acute COPD exacerbations
Describe the frequency and type of antibiotic treatments, treatment duration and their relationship with COPD severity, comorbidities, exacerbation severity and exacerbation etiology
Time frame: From index date (registry inclusion) until the date of first exacerbation of any severity, and any following event of moderate or severe exacerbation, or patient's death, whichever comes first, assessed up to 120 months.
Gas exchange
Describe the prevalence of type I and II respiratory failure, trend over time in PaO2 and PaCo2 and their relationship with acute COPD exacerbations, cardiovascular comorbidities, cardiovascular events and mortality
Time frame: From index date (registry inclusion) until the date of first outpatient visit with available data on gas exchange, and any following event (visit) with gas exchange information, or patient's death, whichever comes first, assessed up to 120 months.
Pneumonia events
incidence and annual pneumonia rate overall and divided by type of patient treatment
Time frame: From index date (registry inclusion) until the date of first pneumonia event of any severity, and any following event of pneumonia, or patient's death, whichever comes first, assessed up to 120 months.
Cardiac function
Describe cardiac function in terms of heart ultrasound parameters at index date and its relationship with future events such as COPD exacerbations, cardiovascular events and mortality
Time frame: From index date (registry inclusion) until the date of first available cardiac ultrasound, and the date of any following cardiac ultrasound assessment, or patient's death, whichever comes first, assessed up to 120 months.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Pulmonary Disease, Chronic Obstructive →