The Dynamics of Clinical Parameters in Romanian COPD Patients Treated With Inhaled Corticosteroid/Long-Acting Beta Agonist Regimens in a Real-World Study (RELIEF)

Abstract

SESSION TITLE: COPD 2 SESSION TYPE: Original Investigation Poster PRESENTED ON: Wednesday, November 1, 2017 at 01:30 PM - 02:30 PM PURPOSE: To describe the dynamics of clinical parameters currently evaluated by physicians in current practice, including exacerbations in chronic obstructive pulmonary disease (COPD) patients treated with inhaled corticosteroid/long-acting beta agonist (ICS/LABA) combinations in real world practice. COPD is a progressive and irreversible disease with gradual debilitation over time and poor clinical outcomes if not appropriately treated. METHODS: RELIEF (CoRELation Between PatIENT Perception and Findings on Clinical Examination) was a non-interventional, multicenter, prospective, 12-weeks study (NCT01627743). A total number of 505 subjects participated in the study at 4 visits:at baseline and at 4, 8 and 12 weeks. Data collected included: demographics, COPD stage, medical history and clinical management, including pharmacological treatment for COPD and comorbidities. RESULTS: The majority of the subjects enrolled in RELIEF study were male (430 subjects, 85.1%). Overall, 489 subjects (96.8%) completed the study. The average age was 65 years (range: 40 to 88 years). The average duration of COPD was 5.31 years, ranging from 0 to 40 years. Majority of subjects were in group C (308 subjects, 61%); a total of 197 subjects were in group D (39%). Most of the subjects (363, 71.9%) had experienced at least 1 exacerbation of their COPD within the previous 12 months. Regarding the ICS/LABA combination used, 54.3% were using salmeterol/fluticasone, and 45.7% budesonide/formoterol. The proportions of subjects reporting signs of obstruction (prolonged expiration, sibilant rales and sonorous rales) decreased from visit 1 to visit 4. The change from visit 1 to visit 4 for sibilant rales was a significant decrease: -13.1% (p <.0001) and for sonorous rales was also a significant decrease: -19.5% (p<.0001). The percentages of patients with signs of cor pulmonale decreased from visit 1 to visit 4. The change in oedemas was a significant decrease: -4.3% (p=0.0391). The percentages of patients with respiratory insufficiency slightly decreased from visit 1 to visit 4. However, there were no significant changes from visit 1 to visit 4 regarding respiratory insufficiency and signs of hyperinflation. During the study, less than 1% of subjects reported visits to the emergency room; ≤1.1% of subjects required hospitalization and less than 1.5% of subjects visited a physician for COPD exacerbations. CONCLUSIONS: Despite the relatively short follow-up, during the 12 weeks of the study there was a significant decrease in the proportions of subjects reporting signs of airwais obstruction, cor pulmonale and number of exacerbations. No significant changes were observed in percentages of patients with respiratory insufficiency or signs of hyperinflation. CLINICAL IMPLICATIONS: This study offers insights about the impact of ICS/LABA from the first weeks of treatment on the evolution of COPD in terms of clinical improvements with relevance for patient relief such as signs of obstruction, cor pulmonale and exacerbation. DISCLOSURE: Florin Mihaltan: Consultant fee, speaker bureau, advisory committee, etc.: speaker's fees, clinical studies and congress fees The following authors have nothing to disclose: Dragos Ungureanu, Gabriela Teodorescu No Product/Research Disclosure Information