Effectiveness and quality of life in asthmatic patients treated with budesonide/formoterol via Elpenhaler® device in primary care. The “SKIRON” real world study

Abstract

Aim: Inhaled corticosteroid (ICS)/long-acting β₂ agonist (LABA) combination therapy is used for the effective control of asthma. Aim of this study was to collect data on the effectiveness, safety, quality of life, and patient satisfaction from a fixed dose combination of budesonide/formoterol administered with the Elpenhaler^® device following 3-months’ treatment.Methods: A 3-month real-life, multicentre, one-arm, prospective observational study (SKIRON study-NCT03055793) was conducted, using the following questionnaires: Asthma Control Questionnaire (ACQ-6) for asthma control assessment, MiniAQLQ questionnaire for QoL assessment, and Feeling of Satisfaction with Inhaler questionnaire (FSI-10) for patients’ satisfaction with the inhaler device. Comorbidities and safety data were also recorded during the study.Results: We enrolled 1,174 asthmatic patients following standard clinical practice in primary care from 126 sites in urban and rural areas of Greece. The majority of patients (71.5%) had at least one comorbidity. A statistically significant improvement in the ACQ-6 score was noted at 3 months compared to the baseline evaluation (mean ± SD 2.19 ± 0.97 at baseline vs. 0.55 ± 0.56 at 3 months; mean change −1.64 (95%CI −1.69, −1.57), p < 0.0001). MiniAQLQ score was statistically and clinically significantly improved, compared to baseline, (4.55 ± 1.04 at baseline vs. 6.37 ± 0.64 at 3 months; mean change 1.82 (95%CI 1.75, 1.87), p < 0.0001). The mean FSI-10 score of 44.2 ± 5.4 indicated patient satisfaction and ease-of-use of the Elpenhaler^® device.Conclusions: In this large real-world study of inadequately-controlled asthma patients in primary care settings, the treatment with budesonide/formoterol FDC with the Elpenhaler^® device was associated with significant improvement in patients’ asthma control and quality of life.

Keywords:

• Asthma
• fixed-dose budesonide/formoterol
• quality of life
• asthma control
• dry powder inhaler
• feeling of satisfaction with inhaler
• Elpenhaler^® device
• observational
• primary care

Acknowledgements

We would like to thank all internists and general practitioners, members of SKIRON study group for their participation in the conduct of the study: Kalliopi Azeli, Sofia Athanasia, Anastasia Alexandratou, Theodoros Alexandropoulos, Konstantinos Amantos, Konstantina Anagnostopoulou, Vasilios Andreadis, George Andreopoulos, Antonios Antoniadis, George Antonogiannakis, Dimitrios Apostolidis, Kyriakos Argyrakis, George Valkaniotis, Polyxeni Vamvaka, Maria Vasilaina, Aikaterini Vasiloglou, George Vafiadis, Stylianos Vitzilaios, Elias Vlassis, Eleni Vlassopoulou, Evangelos Voliotis, Olga Vranou, Fani Galazoula, Athanasios Galis, Eleni Georgiadou, Chrysoula Georgopoulou, Ignatios Giavazis, Ioannis Giannakakis, Vasilios Grapsas, Petros Delidimoudis, Ioannis Dermitzakis, Konstantinos Dimitriadis, Iordanis Dimitsikoglou, Athanasios Diamantopoulos, Ioannis Douloumpakas, George Drogitis, Ioannis Zafiris, Panagiotis Theodoropoulos, Dimitra Kakaki, Dimitrios Kakaridis, Spartakos Kalaitsidis, Fragiskos Kapitsimadis, Panagiota Karagianni, Fotini Karakontaki, Ioanna Karampatsi, Angeliki Karantzali, Christos Karatsokis, Theodoros Karachalios, Fotini Karachaliou, George Kardaris, George Karras, Evangelia Kartelia, Ioannis Kastrinakis, Eleonora Kella, Marietta Kokkala, Ioanna Kolovou, Victoria Kotoula, Irene Koukopoulou, Leonidas Kostalas, Christina Kotsanti, Stylianos Lazarou, Nikolaos Lathourakis, Vasilios Lekakis, Athanasios Liapis, Vasiliki Mathioulaki, Stamatoula Makri, Eleni Makrinori, Leukothea Maniati, Demosthenes Mantzoukis, Maria Marketaki, George Mastorakis, Panagiota Mitrou, Zambia Micheloudaki, Chrysanthi Mourouzi, Konstantina Bakalakou, Loukas Balokas, Evangelos Benidis, Chrysavgi Bibika, Vasilios Bouloukos, Ioannis Boutsikas, Efstathios Nanos, Achilleas Nieris, Vasilios Ntaoulas, Konstantinos Palialexis, Ioannis Paliouras, Panagiotis Panagiotopoulos, Efstathios Papadopoulos, Michael Papamichael, Christos Papastasinos, Ioannis Paradias, Efstathia Paraskevopoulou, Andreas Pastras, Elias Pelekanos, Antonios Pittas, George Pigkas, Spyridon Politis, Vlassis Polychronopoulos, Petros Prokopis, Irene Riniotou, Paraskevi Savvari, Athanasios Salagoudis, Theofilos Sachinidis, Anna Sklaveniti, Vasilios Skouras, Paraskevi Sbarouni, Elias Stavridis, Ioanna Stavrou, Georgia Strimpouli, George Sfikas, Petros Tapinis, Vaya Tatola, Kanella Tziarou, Ioannis Tzinas, Dimitrios Tzoanopoulos, Thomas Tiligadas, Nikolaos Touroukis, Simon Tsalkitzis, Emmanuel Tsirekas, Dimitrios Tsodoulos, Panagiota Fardi, Sofia Florou, Dimitrios Fragakis, Konstantinos Fragoulis, Dimitrios Fylaktopoulos, Zoe Fotinou, Konstantinos Chalkias, Anastasios Chatzopoulos, Maria Chorti, Dimitrios Chountis, Sofia Christaki, Dimitrios Chrysis.

Author contributions

All authors contributed equally to the development of this manuscript.

Declaration of interest

P. Steiropoulos has received honoraria for presentations and consultancy fees from Astra-Zeneca, Boehringer Ingelheim, Chiesi, GSK, Elpen, Menarini and Specialty Therapeutics. His department has received funding and grants from Astra-Zeneca, Chiesi, GSK, Elpen, and Menarini.

K.P. Exarchoshas received honoraria for presentations and consultancy fees from Novartis.

M. Bertoli was an employee of ELPEN Pharmaceutical Co. Inc. at the time SKIRON study was conducted.

F. Karakontaki has received honoraria for presentations and consultancy fees from ELPEN Pharmaceutical Co. Inc.

G. Antonogiannakis: I have received honoraria for presentations and consultancy fees from ELPEN and PFIZER.

V. Polychronopoulos has received honoraria for presentations and consultancy fees from Menarini Hellas Α.Ε and ELPEN Pharmaceutical Co. Inc.

A. Gogali has received honoraria for presentations and consultancy fees from AstraZeneca, Boehringer Ingelheim, Chiesi, ELPEN, GSK, Novartis.

Κ. Kostikas: I have received honoraria for presentations and consultancy fees from AstraZeneca, Boehringer Ingelheim, Chiesi, CSL Behring, ELPEN, GSK, Menarini, Novartis, Sanofi Genzyme and

WebMD. My department has received funding and grants from AstraZeneca, Boehringer Ingelheim, Chiesi, Innovis, ELPEN, GSK, Menarini, Novartis and NuvoAir. I am a member of the GOLD Assembly.

Additional information

Funding

This study was sponsored by ELPEN Pharmaceutical Co. Inc.