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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...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2019
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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. |
format | Online Article Text |
id | pubmed-6824392 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
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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