The Italian Registry of Patients with Chronic Obstructive Pulmonary Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-30

Study Completion Date

2035-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COPD COPD Exacerbation Acute Comorbid Chronic Lung Disease on Heart Failure Mortality Cardiovascular Diseases Cardiovascular Events COPD Prevalance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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COPD patients

All patients with a functionally confirmed diagnosis of COPD

Pharmacological treatment

Intervention Type OTHER

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

Pharmacological treatment

Intervention Type 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:

* 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

Interventions

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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

Intervention Type OTHER

Pharmacological treatment

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

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No