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A Multicenter, Observational, Prospective Study of the Effectiveness of Switching from Budesonide/Formoterol Turbuhaler(®) to Budesonide/Formoterol Easyhaler(®)

INTRODUCTION: In real-life practice, asthma remains poorly controlled, with a considerable burden on patients’ quality of life. Budesonide/formoterol (B/F) Easyhaler(®) has demonstrated similar dose consistency, therapeutic equivalence, and equivalent bronchodilator efficacy to B/F Turbuhaler(®), bu...

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Autores principales: Syk, Jörgen, Vinge, Ines, Sörberg, Mikael, Vahteristo, Mikko, Rytilä, Paula
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6824392/
https://www.ncbi.nlm.nih.gov/pubmed/30941722
http://dx.doi.org/10.1007/s12325-019-00940-7
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author Syk, Jörgen
Vinge, Ines
Sörberg, Mikael
Vahteristo, Mikko
Rytilä, Paula
author_facet Syk, Jörgen
Vinge, Ines
Sörberg, Mikael
Vahteristo, Mikko
Rytilä, Paula
author_sort Syk, Jörgen
collection PubMed
description INTRODUCTION: In real-life practice, asthma remains poorly controlled, with a considerable burden on patients’ quality of life. Budesonide/formoterol (B/F) Easyhaler(®) has demonstrated similar dose consistency, therapeutic equivalence, and equivalent bronchodilator efficacy to B/F Turbuhaler(®), but no real-life comparisons are yet available in patients switching from B/F Turbuhaler(®) to B/F Easyhaler(®). METHODS: The primary objective of this real-life, non-interventional, observational study was to show non-inferiority of asthma control when adult patients in Swedish primary care with persistent asthma switched from B/F Turbuhaler(®) to B/F Easyhaler(®). At visit 1, baseline demographic and endpoint data were recorded, and eligible patients switched to B/F Easyhaler(®). The study comprised a control visit (visit 2) and a concluding examination (visit 3) after 12 weeks. Asthma control was assessed using the Asthma Control Test (ACT). The mini-Asthma Quality of Life Questionnaire (AQLQ) and lung function test were performed, and participants and investigators answered questionnaires about ease-of-use and teaching. RESULTS: A total of 117 patients were enrolled in the on-treatment population; 81 (64.8%) were female. At visit 3, B/F Easyhaler(®) demonstrated non-inferiority to B/F Turbuhaler(®); the mean difference in change from baseline ACT was statistically significant (18.9 vs. 20.7, respectively; p < 0.0001) and met the non-inferiority criteria of B/F Easyhaler(®) being greater than − 1.5 points versus the reference product. Asthma was well controlled in 62 (53.0%) patients at baseline, increasing to 83 patients (70.9%) at visit 3. Patients experienced statistically significant improvements in mini-AQLQ score after B/F Easyhaler(®) treatment and lung function remained stable across the treatment period. B/F Easyhaler(®) was easy to learn and prepare for use. CONCLUSION: This real-life, non-interventional, non-inferiority study in adults with persist asthma demonstrates equivalent or better disease control when patients switch from B/F Turbuhaler(®) to B/F Easyhaler(®). A further study with direct comparison between treatments could add to the understanding of inhaler switch. FUNDING: Orion Corporation, Orion Pharma. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s12325-019-00940-7) contains supplementary material, which is available to authorized users.
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spelling pubmed-68243922019-11-06 A Multicenter, Observational, Prospective Study of the Effectiveness of Switching from Budesonide/Formoterol Turbuhaler(®) to Budesonide/Formoterol Easyhaler(®) Syk, Jörgen Vinge, Ines Sörberg, Mikael Vahteristo, Mikko Rytilä, Paula Adv Ther Original Research INTRODUCTION: In real-life practice, asthma remains poorly controlled, with a considerable burden on patients’ quality of life. Budesonide/formoterol (B/F) Easyhaler(®) has demonstrated similar dose consistency, therapeutic equivalence, and equivalent bronchodilator efficacy to B/F Turbuhaler(®), but no real-life comparisons are yet available in patients switching from B/F Turbuhaler(®) to B/F Easyhaler(®). METHODS: The primary objective of this real-life, non-interventional, observational study was to show non-inferiority of asthma control when adult patients in Swedish primary care with persistent asthma switched from B/F Turbuhaler(®) to B/F Easyhaler(®). At visit 1, baseline demographic and endpoint data were recorded, and eligible patients switched to B/F Easyhaler(®). The study comprised a control visit (visit 2) and a concluding examination (visit 3) after 12 weeks. Asthma control was assessed using the Asthma Control Test (ACT). The mini-Asthma Quality of Life Questionnaire (AQLQ) and lung function test were performed, and participants and investigators answered questionnaires about ease-of-use and teaching. RESULTS: A total of 117 patients were enrolled in the on-treatment population; 81 (64.8%) were female. At visit 3, B/F Easyhaler(®) demonstrated non-inferiority to B/F Turbuhaler(®); the mean difference in change from baseline ACT was statistically significant (18.9 vs. 20.7, respectively; p < 0.0001) and met the non-inferiority criteria of B/F Easyhaler(®) being greater than − 1.5 points versus the reference product. Asthma was well controlled in 62 (53.0%) patients at baseline, increasing to 83 patients (70.9%) at visit 3. Patients experienced statistically significant improvements in mini-AQLQ score after B/F Easyhaler(®) treatment and lung function remained stable across the treatment period. B/F Easyhaler(®) was easy to learn and prepare for use. CONCLUSION: This real-life, non-interventional, non-inferiority study in adults with persist asthma demonstrates equivalent or better disease control when patients switch from B/F Turbuhaler(®) to B/F Easyhaler(®). A further study with direct comparison between treatments could add to the understanding of inhaler switch. FUNDING: Orion Corporation, Orion Pharma. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s12325-019-00940-7) contains supplementary material, which is available to authorized users. Springer Healthcare 2019-04-02 2019 /pmc/articles/PMC6824392/ /pubmed/30941722 http://dx.doi.org/10.1007/s12325-019-00940-7 Text en © The Author(s) 2019, corrected publication [2019] Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Research
Syk, Jörgen
Vinge, Ines
Sörberg, Mikael
Vahteristo, Mikko
Rytilä, Paula
A Multicenter, Observational, Prospective Study of the Effectiveness of Switching from Budesonide/Formoterol Turbuhaler(®) to Budesonide/Formoterol Easyhaler(®)
title A Multicenter, Observational, Prospective Study of the Effectiveness of Switching from Budesonide/Formoterol Turbuhaler(®) to Budesonide/Formoterol Easyhaler(®)
title_full A Multicenter, Observational, Prospective Study of the Effectiveness of Switching from Budesonide/Formoterol Turbuhaler(®) to Budesonide/Formoterol Easyhaler(®)
title_fullStr A Multicenter, Observational, Prospective Study of the Effectiveness of Switching from Budesonide/Formoterol Turbuhaler(®) to Budesonide/Formoterol Easyhaler(®)
title_full_unstemmed A Multicenter, Observational, Prospective Study of the Effectiveness of Switching from Budesonide/Formoterol Turbuhaler(®) to Budesonide/Formoterol Easyhaler(®)
title_short A Multicenter, Observational, Prospective Study of the Effectiveness of Switching from Budesonide/Formoterol Turbuhaler(®) to Budesonide/Formoterol Easyhaler(®)
title_sort multicenter, observational, prospective study of the effectiveness of switching from budesonide/formoterol turbuhaler(®) to budesonide/formoterol easyhaler(®)
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6824392/
https://www.ncbi.nlm.nih.gov/pubmed/30941722
http://dx.doi.org/10.1007/s12325-019-00940-7
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