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| Name | Class |
|---|---|
| University of Genova | OTHER |
| University of Pavia | OTHER |
| Azienda Ospedaliera Universitaria Integrata Verona | OTHER |
| University Magna Graecia |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD patients | All patients with a functionally confirmed diagnosis of COPD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacological treatment | Other | Pharmacological and non pharmacological treatments will be assessed and monitored during the retrospective and prospective phase, and will include:
|
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | Annual all-cause mortality rate | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular mortality | Annual death rate for cardiovascular events | From index date (registry inclusion) until the date of death provoked by a cardiovascular event, assessed up to 120 months |
| Cardiovascular comorbidities |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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:
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All patients with functionally confirmed COPD and a track medical record in the 12 months before enrollment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luigi Sacco University Hospital, Division of Department of Biomedical and Clinical Sciences, University of Milan | Milan | Milan | 20157 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38444551 | Background | Santus P, Di Marco F, Braido F, Contoli M, Corsico AG, Micheletto C, Pelaia G, Radovanovic D, Rogliani P, Saderi L, Scichilone N, Tanzi S, Vella M, Boarino S, Sotgiu G, Solidoro P. Exacerbation Burden in COPD and Occurrence of Mortality in a Cohort of Italian Patients: Results of the Gulp Study. Int J Chron Obstruct Pulmon Dis. 2024 Mar 1;19:607-618. doi: 10.2147/COPD.S446636. eCollection 2024. | |
| 31500459 |
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| OTHER |
| University of Rome Tor Vergata | OTHER |
| Università degli Studi di Sassari | OTHER |
| University of Palermo | OTHER |
| University of Turin, Italy | OTHER |
| University Hospital Verona, Italy | UNKNOWN |
| University Hospital of Ferrara | OTHER |
| Societa Italiana di Pneumologia | OTHER |
| Italian Association of Hospital Pneumologists | OTHER |
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|
| Pharmacological treatment | Other | 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:
|
|
prevalence of cardiovascular comorbidities and their relationship with lung function, respiratory symptoms, moderate and severe exacerbations, mortality
| 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 | 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 | 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 | 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 | 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 |
| 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 | 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 | 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 | 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 | 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 | 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. |
| Background |
| Radovanovic D, Contoli M, Marco FD, Sotgiu G, Pelaia G, Braido F, Corsico AG, Micheletto C, Rogliani P, Scichilone N, Saderi L, Santus P, Solidoro P. Clinical and Functional Characteristics of COPD Patients Across GOLD Classifications: Results of a Multicenter Observational Study. COPD. 2019 Aug;16(3-4):215-226. doi: 10.1080/15412555.2019.1659760. Epub 2019 Sep 9. |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D002318 | Cardiovascular Diseases |
| D004646 | Emphysema |
| D029481 | Bronchitis, Chronic |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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