A new formulation of fluticasone propionate/salmeterol in a metered-dose inhaler (MDI HFA) allows for the reduction of a daily dose of corticosteroid and provides optimal asthma control - A randomized, multi-center, non-inferiority, phase IV clinical study.

Autor: Kupczyk M; Dept. of Internal Medicine, Asthma and Allergy, Medical University of Lodz, ul. Kopcinskiego 22, 90-153, Lodz, Poland. Electronic address: maciej.kupczyk@umed.lodz.pl., Majak P; Dept. of Internal Medicine, Asthma and Allergy, Medical University of Lodz, ul. Kopcinskiego 22, 90-153, Lodz, Poland., Kuna P; Dept. of Internal Medicine, Asthma and Allergy, Medical University of Lodz, ul. Kopcinskiego 22, 90-153, Lodz, Poland., Asankowicz-Bargiel B; Asankowicz-Bargiel & Partners, Outpatient Specialist Clinic, ul. Pilsudskiego 33, 63-400, Ostrow Wielkopolski, Poland., Barańska E; Specialist Outpatient Clinic, ul. Wojska Polskiego 44, 64-800, Chodziez, Poland., Dobek R; Manamedica Medical Center, ul. Inwalidow Wojennych 13, 56-100, Wolow, Poland; Institute of Tuberculosis and Lung Diseases, ul. Plocka 26, 01-138, Warszawa, Poland., Garbicz S; Pulmonology & Allergology Outpatient Clinic, ul. Hubalczykow 5, 76-200, Slupsk, Poland., Jerzyńska J; Amicare Research Center, ul. Zeligowskiego 46 lok. 10, 90-644, Lodz, Poland., Latos A; Artimed Medical Center, ul. Paderewskiego 4B, 25-017, Kielce, Poland., Machowiak W; Intermedius Medical Service, ul. Rynek 19, 64-000, Koscian, Poland., Majorek-Olechowska B; Alergomed Medical Center, ul. PCK 26, 33-100, Tarnow, Poland., Olech-Cudzik A; Ostrowiec Medical Center, ul. Ilzecka 31a, 27-400, Ostrowiec Sw., Poland., Poziomkowska-Gęsicka I; Dept of Clinical Allergology, Pomeranian Medical University of Szczecin, ul. Powstancow Wlkp. 72, 70-111, Szczecin, Poland., Rulewicz-Warniełło M; Specialist Outpatient Clinic for Pulmonary Diseases, ul. Krotka 4, 11-400, Ketrzyn, Poland., Świderska A; Allergology Outpatient Clinic, ul. Joanny Zubr 18, 98-300, Wielun, Poland., Tarnowski M; Pharmaceutical Company LEK-AM, Al. Jana Pawła II 80, 00-175, Warszawa, Poland., Kopyto P; QAH CRO, ul. Stefana Skrzywana 6, 93-588, Lodz, Poland.
Jazyk: angličtina
Zdroj: Respiratory medicine [Respir Med] 2021 Jan; Vol. 176, pp. 106274. Date of Electronic Publication: 2020 Nov 29.
DOI: 10.1016/j.rmed.2020.106274
Abstrakt: Background: Improvement of the delivery method of inhaled corticosteroids and subsequent dose reduction can minimize the risk of unfavorable outcomes while providing optimal asthma control.
Objective: This randomized, multi-center, non-inferiority, phase IV clinical study compared the efficacy and safety of a new formulation of fluticasone propionate/salmeterol (250 μg/50 μg, twice daily) administered in a metered-dose inhaler hydrofluoroalkane (MDI HFA) with a dry-powder inhaler (DPI) containing fluticasone propionate/salmeterol (500 μg/50 μg, twice daily).
Methods: Adults with asthma (n = 231) were randomly assigned to either the study group (treated for 12 weeks with fluticasone propionate/salmeterol MDI HFA) or a control group (treated for 12 weeks with fluticasone propionate/salmeterol DPI). Asthma symptoms, exacerbations, short-acting β 2 -agonist (SABA) use, physical activity, lung function, and general health status were assessed during four study visits.
Results: Compared with the reference drug, the study drug decreased the incidence of daytime and night-time asthma symptoms, asthma exacerbations, self-administration of SABA, and the limitation of physical activity. Comparable improvement in peak expiratory flow ([MDI HFA] from 6.2 ± 0.2 to 6.6 ± 0.2 l/s vs. [DPI] from 6.0 ± 0.2 to 6.9 ± 0.2 l/s; p > 0.05), forced expiratory volume in one second, and forced vital capacity were obtained in both groups. Significantly lower incidence of hoarseness was observed in the study group ([MDI HFA] 0.0% vs. [DPI] 2.8%; p = 0.0267); no major differences were found for other adverse events.
Conclusions: Fluticasone propionate/salmeterol (250 μg/50 μg, twice daily) MDI HFA provides optimal asthma control and is non-inferior to fluticasone propionate/salmeterol (500 μg/50 μg, twice daily) DPI.
(Copyright © 2020 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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