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A Multicenter, Observational, Prospective Study of the Effectiveness of Switching from Budesonide/Formoterol Turbuhaler® to Budesonide/Formoterol Easyhaler®
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Research group (Dept. of women´s and children´s health), Paediatric Inflammation Research. Karolinska Inst, Care Sci & Soc, Dept Neurobiol, Stockholm, Sweden;Acad Primary Hlth Care Ctr, Stockholm, Sweden.
Lidingo Hosp, Asthma Allergy Lung Dept, Lidingo, Sweden.
Orion Pharma, Sollentuna, Sweden.
Orion Corp, Orion Pharma, Kuopio, Finland.
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2019 (English)In: Advances in Therapy, ISSN 0741-238X, E-ISSN 1865-8652, Vol. 36, no 7, p. 1756-1769Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2019. Vol. 36, no 7, p. 1756-1769
Keywords [en]
Asthma, Asthma control, Inhaler technique, Inhaler preference, Inhaler switch, Budesonide, formoterol Turbuhaler((R)), formoterol Easyhaler((R))
National Category
Respiratory Medicine and Allergy
Identifiers
URN: urn:nbn:se:uu:diva-390994DOI: 10.1007/s12325-019-00940-7ISI: 000474351400018PubMedID: 30941722OAI: oai:DiVA.org:uu-390994DiVA, id: diva2:1343464
Note

Correction in: ADVANCES IN THERAPY, Volume: 36, Issue: 7, Pages: 1770-1770, DOI: 10.1007/s12325-019-00975-w

Available from: 2019-08-16 Created: 2019-08-16 Last updated: 2019-08-16Bibliographically approved

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