Exacerbations and Lung Function in Polish Patients with Chronic Obstructive Pulmonary Disease Treated with ICS/LABA: 2-Year Prospective, Observational Study

Background: To assess the frequency of chronic obstructive pulmonary disease (COPD) exacerbations and their association with lung function in patients treated with ICS/LABA in everyday medical practice in Poland, we conducted a prospective observational study. Methods: Patients diagnosed with COPD for at least 12 months before enrolment and ambulatory treatment with ICS/LABA for at least 6 months before study entry were followed up for 2 years after the initial visit. At four subsequent visits, data on pulmonary function, exacerbations, and symptoms were collected. The severity of airflow limitation was assessed using the %pred. (GOLD), and z-scores (ATS/ERS 2022). Results: At each visit, approximately 80% of the patients had an mMRC ≥ 2 and CAT score ≥ 10. In 330 patients defined as 'decliners, ’ a decrease in FEV1 greater than 100 ml was observed. At the initial visit, 76.5% of patients reported exacerbation of COPD in the 12-months period preceding study entry. At each subsequent visit, fewer exacerbating patients reported hospitalization (from 27.7% at Visit 2 to 18.4% at Visit 4). Regression analysis revealed that the presence of comorbidities and higher mMRC values (OR=1.556 [CI:1.099–2.203], p=0.013 and OR=2.656 [CI:2.163; 3.262], p< 0.001, respectively) were independent factors associated with COPD exacerbations. Conclusions: During the 2-years period, pulmonary function and patient-related outcomes, such as severity of dyspnea measured by mMRC score and CAT, were generally stable throughout the study. Symptoms and comorbidities but not lung function were associated with the risk of exacerbation.