Clinical trial NCT06652776: The Italian Registry of Patients with Chronic Obstructive Pulmonary Disease
Official title: The Italian COPD Registry. the DescribinG BUrden of COPD and Occurrence of MortaLity in a Cohort of Italian Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: COPD
COPD Exacerbation Acute
Comorbid Chronic Lung Disease on Heart Failure
Mortality
Cardiovascular Diseases
Cardiovascular Events
COPD Prevalance
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
Lead sponsor: University of Milan
Sponsor class: OTHER
Collaborators: name: University of Genova
name: University of Pavia
name: Azienda Ospedaliera Universitaria Integrata Verona
name: University Magna Graecia
name: University of Rome Tor Vergata
name: Università degli Studi di Sassari
name: University of Palermo
name: University of Turin, Italy
name: University Hospital Verona, Italy
name: University Hospital of Ferrara
First posted: 2024-10-22
Enrollment: 10000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with functionally confirmed COPD and a track medical record in the 12 months before enrollment

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\&lt;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.

Eligibility criteria: 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)

Primary outcomes:
measure: All cause mortality
timeFrame: From index date (registry inclusion) until the date of death from any cause, assessed up to 120 months
measure: Burden of moderate and severe COPD acute exacerbations
timeFrame: 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
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: From index date (registry inclusion) until the date of death provoked by a cardiovascular event, assessed up to 120 months
measure: Cardiovascular comorbidities
timeFrame: At index date (registry inclusion) comorbidities will be registered and updated at every new visit until patient's death
measure: Cardiovascular events
timeFrame: From index date (registry inclusion) until the date of any cardiovascular event or cardiovascular death, whichever comes first, assessed up to 120 months
measure: Lung function decline
timeFrame: 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
measure: Eosinophil count
timeFrame: 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
measure: Evaluation of the pharmacological treatment at baseline and treatment switches
timeFrame: 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
Other outcomes:
measure: Exacerbation etiology
timeFrame: 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
measure: Corticosteroid treatment during COPD exacerbation
timeFrame: 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.
measure: Antibiotic treatments during acute COPD exacerbations
timeFrame: 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.
measure: Gas exchange
timeFrame: 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.
measure: Pneumonia events
timeFrame: 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.
measure: Cardiac function
timeFrame: 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.
Locations:
city: Milan
country: Italy
facility: Luigi Sacco University Hospital, Division of Department of Biomedical and Clinical Sciences, University of Milan
Study officials:
References:
citation: 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.
citation: 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.