Clinical Effectiveness of Budesonide/Formoterol Fumarate Easyhaler® for Patients with Poorly Controlled Obstructive Airway Disease: a Real-World Study of Patient-Reported Outcomes

Abstract

IntroductionThe effectiveness of inhaled therapies can be influenced by many factors, including the type of inhaler, which may have clinical implications. We report a real-world, multicenter, open-label, non-randomized, non-interventional study conducted by 200 pulmonologists across 200 centers in Hungary. The effectiveness of budesonide/formoterol inhalation therapy in daily clinical practice, delivered via the Bufomix Easyhaler®, was evaluated in patients with asthma, chronic obstructive pulmonary disease (COPD) and asthma-COPD overlap (ACO).MethodsEffectiveness was assessed after 12 weeks of treatment by spirometry, the Asthma Control Test, mini-Asthma Quality of Life Questionnaire, COPD Assessment Test and modified Medical Research Council dyspnea scale. Patient satisfaction with the Bufomix Easyhaler® and physicians’ assessments (ease of use and time taken to learn the technique) were also assessed.ResultsA total of 1498 patients with obstructive airway disease were evaluated (asthma: n = 621; COPD: n = 778; ACO: n = 99), of whom 455 (30.4%) were newly diagnosed inhaler-naïve patients and 1043 (69.6%) were switching from other inhalers. Significant improvements in lung function, disease control and health-related quality of life measures (all p ≤ 0.002) were reported after 12 weeks of Bufomix Easyhaler® use. Improvements were observed in both inhaler-naïve patients and those who switched to a Bufomix Easyhaler® from other devices. After switching, 72.4% of patients regarded the Bufomix Easyhaler® as ‘very good’ and > 90.0% of physicians described the Bufomix Easyhaler® as easy to teach; 73.8% and 98.9% of patients learned the technique within 5 and 10 min of teaching, respectively.ConclusionTwelve weeks’ treatment with the Bufomix Easyhaler® resulted in significant improvements in disease control and quality of life. The Bufomix Easyhaler® was considered easy to use, and most patients were satisfied with the inhaler. Results confirm the real-world effectiveness of the Bufomix Easyhaler® in the treatment of adult outpatients with obstructive airway disease.FundingOrion Corp., Orion Pharma.Electronic supplementary materialThe online version of this article (10.1007/s12325-018-0753-6) contains supplementary material, which is available to authorized users.

Effectiveness and Patient Satisfaction with Budesonide/Formoterol Easyhaler® Among Patients with Asthma or COPD Switching from Previous Treatment: a Real-World Study of Patient-Reported Outcomes

“…This was a post hoc subanalysis of a 12-week, real-world, multicenter, open-label, non-randomized, non-interventional, single-arm study, conducted across 200 Hungarian centers between May 1, 2016 and December 31, 2017 (National Pharmaceutical Institute of Pharmacy and Nutrition of Hungary; trial registration number: OGYÉ I/13942-5/2016) [24]. The study consisted of three visits and assessed treatment effectiveness in patients diagnosed with asthma or COPD who switched from their current inhaler to B/F Easyhaler.…”

“…Budesonide/formoterol fumarate (B/F) Easyhaler Ò (Orion Pharma, Espoo, Finland) is a multidose dry powder inhaler containing a combination of the inhaled corticosteroid, budesonide, and the long-acting b2-adrenergic agonist, formoterol fumarate, indicated for the treatment of adults with COPD and/or asthma, and adolescents aged 12-17 years with asthma [22], and approved in several European countries. Two non-randomized, open-label, singlearm studies conducted in Poland and Hungary have confirmed the effectiveness of the B/F Easyhaler for the treatment of asthma [23], COPD, and asthma-COPD overlap (ACO) [24] in everyday clinical practice. In the latter study, 30.4% of patients were inhaler-naïve and 69.6% switched to the B/F Easyhaler from other inhalers; after 12 weeks of treatment, significant improvements in lung function, disease control, and HRQoL (all p B 0.002) were observed in both inhaler-naive patients and switchers [24].…”

“…Two non-randomized, open-label, singlearm studies conducted in Poland and Hungary have confirmed the effectiveness of the B/F Easyhaler for the treatment of asthma [23], COPD, and asthma-COPD overlap (ACO) [24] in everyday clinical practice. In the latter study, 30.4% of patients were inhaler-naïve and 69.6% switched to the B/F Easyhaler from other inhalers; after 12 weeks of treatment, significant improvements in lung function, disease control, and HRQoL (all p B 0.002) were observed in both inhaler-naive patients and switchers [24]. However, neither study stratified by prior treatment, precluding comparisons of the effect of switching from specific inhaler devices to the B/F Easyhaler.…”

“…Inclusion and exclusion criteria have been previously described [24]. Eligible patients were C 18 years of age with a diagnosis of asthma or COPD (according to Global Initiative for Asthma [GINA] [1] or Global Initiative for Chronic Obstructive Lung Disease therapeutic guidelines [7]), and without an exacerbation in the 4 weeks before enrollment.…”

“…Here, we present subgroup analysis of the Hungarian study reported by Tamási et al [24]. In the present analyses, patients were stratified by inhaler device used at baseline to confirm the real-world clinical benefits of the B/F Easyhaler in patients with asthma or COPD, and to compare measures of clinical effectiveness, HRQoL, and patient satisfaction associated with the B/F Easyhaler versus the patient's prior inhaler device.…”