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, 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.