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Background: Chronic Obstructive Pulmonary Disease (COPD) is an inflammatory lung disease characterized by airflow limitation that is not completely reversible. The fixed-dose combination of salmeterol and fluticasone propionate (SFC) has been approved as a treatment for COPD patients with a history of recurrent exacerbations and significant symptoms despite regular bronchodilator therapy. In the present study, we evaluated the change in FEV 1 , mMRC dyspnea score and satisfaction in COPD patients with at least one comorbidity versus those without comorbidities treated with a fixed-dose SFC via the Elpenhaler ®  device for 12 months. Methods: A 12-month multicenter prospective, observational study (NCT02978703) was designed. Data were collected during the enrollment visit (V0) and six (V1) and twelve months (V2) after the initiation of treatment with Elpenhaler ®  SFC. The evaluation of the efficacy of the fixed-dose SFC was performed by assessing the change in lung function and dyspnea as expressed by FEV 1  and the mMRC dyspnea scale score in COPD patients with and without comorbidities. Results: In total 1016 patients were enrolled, following usual daily clinical practice. A statistically significant improvement was observed in FEV 1  in the total study population between visits V0, V1 and V2, with a change from the baseline at V1 0.15 ± 0.22 L and at V2 0.21 ± 0.25 L ( p  < 0.0001 for both comparisons). This improvement was exhibited regardless of the COPD severity at the baseline, being more noticeable in GOLD 2020 groups B and C. Similarly, a significant improvement was observed in mMRC dyspnea scale values between successive visits ( p  < 0.0001). In patients without comorbidities, there was a significant improvement in FEV 1  of 0.19 ± 0.24 L at V1 and 0.28 ± 0.27 L at V2 ( p  < 0.0001 for both comparisons), as well as in the mMRC dyspnea score ( p  < 0.0001). In patients with at least one comorbidity, a corresponding but smaller improvement in FEV 1  was observed (0.11 ± 0.34 L at V1 and 0.20 ± 0.42 L at V2;  p  < 0.0001 for both comparisons and in the mMRC score ( p  < 0.0001). In the multiple linear regression analysis BMI, GOLD 2020 groups, mMRC and the presence of comorbidities at the baseline were significant factors for the change of FEV 1  between V0 and V2. Conclusions: COPD patients treated for twelve months with SFC via the Elpenhaler ®  device showed significant improvement in lung function and dyspnea at 6 and 12 months, irrespective of the presence of comorbidities.

journal of personalized medicine

Evaluation of the Clinical Effectiveness of the Salmeterol/Fluticasone Fixed-Dose Combination Delivered via the Elpenhaler® Device in Greek Patients with Chronic Obstructive Pulmonary Disease and Comorbidities: The AEOLOS Study