Observational Study On The Characterization Of 24-Hour Symptoms In Patients With COPD

Primary objective - cross-sectional phase 1. To describe the frequency of early-morning, day- and night-time COPD symptoms according to phenotypes in a cohort of Italian patients with stable COPD (GOLD 2014 criteria). Symptoms will be evaluated by means of the Night-Time, Morning and Day-Time symptoms of COPD questionnaire. Primary objective - longitudinal phase 1. To describe the 12-month frequency and evolution of early-morning, day- and night-time COPD symptoms according to phenotypes measured at enrolment. Symptoms will be evaluated by means of the Night-Time, Morning and Day-Time symptoms of COPD questionnaire. Secondary objectives - cross sectional phase 1. To evaluate the association between early-morning, day- and night-time symptoms frequency at enrolment and the following outcomes: • dyspnea level • disease severity, as defined by the GOLD 2014 criteria (stages A to D) • quality of life • physical activity • quality of sleep • frequency and severity of exacerbations • level of depression and anxiety Secondary objectives - longitudinal phase 1. To describe the 12-month variation of the following outcomes according to phenotypes measured at enrolment: • dyspnea level • quality of life • physical activity • quality of sleep • frequency and severity of exacerbations • level of depression and anxiety 2. To describe the healthcare resources utilization in a cohort of Italian patients with COPD during 12-month observation, globally and by phenotypes. STUDY DESIGN: Italian observational cohort multicentre study in patients with stable COPD PLANNED NUMBER OF SUBJECTS: 600 patients STUDY PROCEDURE The study plan foresees: -Enrolment visit \[Baseline visit (V1)\] -A control visit at 6 months since Baseline at the investigational site (V2) -A final visit at 12 months since Baseline at the investigational site (V3) The clinical staff at the investigational sites will collect retrospectively all the necessary information about the medical history of the patient to confirm his-her eligibility. Patients confirmed with a diagnosis of stable COPD will be evaluated at enrolment visit and, if eligible, they will be asked to provide a written and signed privacy and informed consent form. The diagnosis of stable COPD should be compliant with 2014 GOLD criteria (stages A to D). At enrolment visit, patients will be asked to complete questionnaires for early-morning, day- and night-time symptoms, level of dyspnea, quality of life, physical activity, anxiety and depression levels, sleep quality, as well as to provide data on lifestyle, such as smoking. The investigator will be requested to complete study case report forms (CRFs) recording specified baseline information (demography data, medical history and comorbidities, COPD phenotype, ongoing treatments for COPD). Finally patients will perform a spirometry (baseline, lung volumes, bronchodilation test and CO diffusion) according to routine clinical practice. No additional mandated interventions on top of routinely performed physician visits, examinations or treatments will be required. Except the completion of the questionnaires, there are no other study-prescribed procedures. Any procedure ordered by the physician during this study will be one that is appropriate to the routine clinical care delivered to the COPD patients at the discretion of the physician. After 6 and 12 months, the same information as in the enrolment visits will be collected, excluding demographic data, to ascertain any changes in the outcomes of interest, including any exacerbations and medical healthcare resources utilization in the period between the visits. At follow up visits, patients will undergo the same procedures (spirometry) performed at the enrolment visit. For the entire period of observation, data regarding Adverse Event/Serious Adverse Event will be collected.