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A Multicenter, Observational, Prospective Study of the Effectiveness of Switching from Budesonide/Formoterol Turbuhaler® to Budesonide/Formoterol Easyhaler®
Uppsala universitet, Medicinska och farmaceutiska vetenskapsområdet, Medicinska fakulteten, Institutionen för kvinnors och barns hälsa, Forskargrupper (Inst. för kvinnor och barns hälsa), Pediatrisk inflammationsforskning. 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.
Vise andre og tillknytning
2019 (engelsk)Inngår i: Advances in Therapy, ISSN 0741-238X, E-ISSN 1865-8652, Vol. 36, nr 7, s. 1756-1769Artikkel i tidsskrift (Fagfellevurdert) 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.

sted, utgiver, år, opplag, sider
2019. Vol. 36, nr 7, s. 1756-1769
Emneord [en]
Asthma, Asthma control, Inhaler technique, Inhaler preference, Inhaler switch, Budesonide, formoterol Turbuhaler((R)), formoterol Easyhaler((R))
HSV kategori
Identifikatorer
URN: urn:nbn:se:uu:diva-390994DOI: 10.1007/s12325-019-00940-7ISI: 000474351400018PubMedID: 30941722OAI: oai:DiVA.org:uu-390994DiVA, id: diva2:1343464
Merknad

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

Tilgjengelig fra: 2019-08-16 Laget: 2019-08-16 Sist oppdatert: 2019-08-16bibliografisk kontrollert

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