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

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...

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Autores principales:	Paschalis Steiropoulos, Stavros Tryfon, Christos Kyriakopoulos, Konstantinos Bartziokas, Konstantinos Kostikas
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	COPD FEV<sub>1</sub> mMRC salmeterol and fluticasone propionate fixed-dose combination safety analysis Medicine R
Acceso en línea:	https://doaj.org/article/b8b43807233243a88f917652da79365e
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spelling	oai:doaj.org-article:b8b43807233243a88f917652da79365e2021-11-25T18:07:38ZEvaluation of the Clinical Effectiveness of the Salmeterol/Fluticasone Fixed-Dose Combination Delivered via the Elpenhaler<sup>®</sup> Device in Greek Patients with Chronic Obstructive Pulmonary Disease and Comorbidities: The AEOLOS Study10.3390/jpm111111592075-4426https://doaj.org/article/b8b43807233243a88f917652da79365e2021-11-01T00:00:00Zhttps://www.mdpi.com/2075-4426/11/11/1159https://doaj.org/toc/2075-4426Background: 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<sub>1</sub>, 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<sup>®</sup> 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<sup>®</sup> 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<sub>1</sub> 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<sub>1</sub> 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 (<i>p</i> < 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 (<i>p</i> < 0.0001). In patients without comorbidities, there was a significant improvement in FEV<sub>1</sub> of 0.19 ± 0.24 L at V1 and 0.28 ± 0.27 L at V2 (<i>p</i> < 0.0001 for both comparisons), as well as in the mMRC dyspnea score (<i>p</i> < 0.0001). In patients with at least one comorbidity, a corresponding but smaller improvement in FEV<sub>1</sub> was observed (0.11 ± 0.34 L at V1 and 0.20 ± 0.42 L at V2; <i>p</i> < 0.0001 for both comparisons and in the mMRC score (<i>p</i> < 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<sub>1</sub> between V0 and V2. Conclusions: COPD patients treated for twelve months with SFC via the Elpenhaler<sup>®</sup> device showed significant improvement in lung function and dyspnea at 6 and 12 months, irrespective of the presence of comorbidities.Paschalis SteiropoulosStavros TryfonChristos KyriakopoulosKonstantinos BartziokasKonstantinos KostikasMDPI AGarticleCOPDFEV<sub>1</sub>mMRCsalmeterol and fluticasone propionate fixed-dose combinationsafety analysisMedicineRENJournal of Personalized Medicine, Vol 11, Iss 1159, p 1159 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	COPD FEV<sub>1</sub> mMRC salmeterol and fluticasone propionate fixed-dose combination safety analysis Medicine R
spellingShingle	COPD FEV<sub>1</sub> mMRC salmeterol and fluticasone propionate fixed-dose combination safety analysis Medicine R Paschalis Steiropoulos Stavros Tryfon Christos Kyriakopoulos Konstantinos Bartziokas Konstantinos Kostikas Evaluation of the Clinical Effectiveness of the Salmeterol/Fluticasone Fixed-Dose Combination Delivered via the Elpenhaler<sup>®</sup> Device in Greek Patients with Chronic Obstructive Pulmonary Disease and Comorbidities: The AEOLOS Study
description	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<sub>1</sub>, 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<sup>®</sup> 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<sup>®</sup> 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<sub>1</sub> 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<sub>1</sub> 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 (<i>p</i> < 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 (<i>p</i> < 0.0001). In patients without comorbidities, there was a significant improvement in FEV<sub>1</sub> of 0.19 ± 0.24 L at V1 and 0.28 ± 0.27 L at V2 (<i>p</i> < 0.0001 for both comparisons), as well as in the mMRC dyspnea score (<i>p</i> < 0.0001). In patients with at least one comorbidity, a corresponding but smaller improvement in FEV<sub>1</sub> was observed (0.11 ± 0.34 L at V1 and 0.20 ± 0.42 L at V2; <i>p</i> < 0.0001 for both comparisons and in the mMRC score (<i>p</i> < 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<sub>1</sub> between V0 and V2. Conclusions: COPD patients treated for twelve months with SFC via the Elpenhaler<sup>®</sup> device showed significant improvement in lung function and dyspnea at 6 and 12 months, irrespective of the presence of comorbidities.
format	article
author	Paschalis Steiropoulos Stavros Tryfon Christos Kyriakopoulos Konstantinos Bartziokas Konstantinos Kostikas
author_facet	Paschalis Steiropoulos Stavros Tryfon Christos Kyriakopoulos Konstantinos Bartziokas Konstantinos Kostikas
author_sort	Paschalis Steiropoulos
title	Evaluation of the Clinical Effectiveness of the Salmeterol/Fluticasone Fixed-Dose Combination Delivered via the Elpenhaler<sup>®</sup> Device in Greek Patients with Chronic Obstructive Pulmonary Disease and Comorbidities: The AEOLOS Study
title_short	Evaluation of the Clinical Effectiveness of the Salmeterol/Fluticasone Fixed-Dose Combination Delivered via the Elpenhaler<sup>®</sup> Device in Greek Patients with Chronic Obstructive Pulmonary Disease and Comorbidities: The AEOLOS Study
title_full	Evaluation of the Clinical Effectiveness of the Salmeterol/Fluticasone Fixed-Dose Combination Delivered via the Elpenhaler<sup>®</sup> Device in Greek Patients with Chronic Obstructive Pulmonary Disease and Comorbidities: The AEOLOS Study
title_fullStr	Evaluation of the Clinical Effectiveness of the Salmeterol/Fluticasone Fixed-Dose Combination Delivered via the Elpenhaler<sup>®</sup> Device in Greek Patients with Chronic Obstructive Pulmonary Disease and Comorbidities: The AEOLOS Study
title_full_unstemmed	Evaluation of the Clinical Effectiveness of the Salmeterol/Fluticasone Fixed-Dose Combination Delivered via the Elpenhaler<sup>®</sup> Device in Greek Patients with Chronic Obstructive Pulmonary Disease and Comorbidities: The AEOLOS Study
title_sort	evaluation of the clinical effectiveness of the salmeterol/fluticasone fixed-dose combination delivered via the elpenhaler<sup>®</sup> device in greek patients with chronic obstructive pulmonary disease and comorbidities: the aeolos study
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/b8b43807233243a88f917652da79365e
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Evaluation of the Clinical Effectiveness of the Salmeterol/Fluticasone Fixed-Dose Combination Delivered via the Elpenhaler<sup>®</sup> Device in Greek Patients with Chronic Obstructive Pulmonary Disease and Comorbidities: The AEOLOS Study

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