| Popis: |
Introduction: Chronic obstructive pulmonary disease (COPD) is a chronic, inflammatory lung disease characterized by a progressive decline in respiratory function and persistent symptoms such as dyspnea. Objectives: We evaluated the change in %FEV1pred. and MRC dyspnea score in COPD patients treated with fluticasone-salmeterol FDC via Elpenhaler® device for 12 months. Methods: In this prospective, multicenter clinical study (NCT02978703) 1,016 COPD patients, with a mean age of 69.54 ± 9.57 years and a mean BMI of 28.65 ± 5.38 Kg/m2 were enrolled. The efficacy of the fluticasone-salmeterol FDC administered via Elpenhaler® device was assessed by evaluating the %FEV1pred. change and MRC dyspnea score. The corresponding data were collected at baseline (V0), 6 (V1) and 12 (V2) months, respectively. Results: There was a statistically significant improvement (p˂0.0001) in the %FEV1pred. among consecutive visits V0 (baseline) (Mean±SD:48.43±8.61), V1 (Mean±SD:54.17±10.87) and V2 (Mean±SD:56.47±11.82) as well as between baseline and final visit. Similar significant improvement was observed in the values of the MRC dyspnea score between consecutive visits (p˂0.0001, Kruskal-Wallis test). Conclusion: Patients with COPD who were treated with a fluticasone-salmeterol FDC via the Elpenhaler® device showed a significant improvement in pulmonary function and dyspnea, as assessed by the change in %FEV1pred. and by the dyspnea MRC score after 6 and 12 months respectively. |
