The Italian Registry of Patients With Chronic Obstructive Pulmonary Disease
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Pharmacological treatment, Pharmacological treatment.
- Кому может быть актуально
- Состояния в реестре: COPD, COPD Exacerbation Acute, Comorbid Chronic Lung Disease on Heart Failure, Mortality. Базовые параметры: от 40 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Italian COPD Registry. The DescribinG bUrden of COPD and Occurrence of mortaLity in a Cohort of Italian Patients
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое 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 - Другое 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
Первичные конечные точки
- All cause mortality [Срок оценки: 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 [Срок оценки: 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]
Вторичные конечные точки (6)
- Cardiovascular mortality [Срок оценки: From index date (registry inclusion) until the date of death provoked by a cardiovascular event, assessed up to 120 months]
- Cardiovascular comorbidities [Срок оценки: At index date (registry inclusion) comorbidities will be registered and updated at every new visit until patient's death]
- Cardiovascular events [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- Presence of current clinically significant asthma
- Diagnosis or clinically significant alternative respiratory diseases (such as interstitial lung disease or bronchiectasis)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 1 центр
- Luigi Sacco University Hospital, Division of Department of Biomedical and Clinical Science — Milan
Публикации
- 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. PMID 38444551
- 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. PMID 31500459
Идентификаторы
NCT: NCT06652776 · 20-27Sept2023