Table 1.

Available device comparisons which include Easyhaler

Study	Country	Aim	Study design and population	Study characteristics	Study results	Main outcome
Syk et al. [53]	Sweden	Real-life comparison in asthma patients on budesonide/formoterol treatment switching device from Turbuhaler to Easyhaler	Real-life, non-interventional, non-inferiority study in adults with persistent asthma (n = 117)	A baseline visit (demographic and endpoint data were recorded, and eligible patients switched to B/F Easyhaler), was followed by a control visit and a concluding examination visit after 12 weeks. Asthma control was assessed using the Asthma Control Test. The mini-Asthma Quality of Life Questionnaire and lung function test were also performed. Moreover, participants and investigators answered questionnaires about ease of learning and ease of use	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 criterion of B/F Easyhaler being greater than – 1.5 points better than the reference product. Asthma was well controlled in 62 patients (53.0%) at baseline, increasing to 83 (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	Asthma patients switching from Symbicort Turbuhaler to Easyhaler had comparable or improved disease control. 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
Tamási et al. [33]	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)	Real-world, multicenter, open-label, non-randomized, non-interventional study conducted by 200 pulmonologists across 200 centers. A 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	Effectiveness was assessed after 12 weeks of treatment using spirometry, Asthma Control Test, mini-Asthma Quality of Life Questionnaire, COPD Assessment Test and modified Medical Research Council dyspnoea scale. Patient satisfaction with the Bufomix Easyhaler and physicians’ assessments (ease of use and time taken to learn the technique) were also assessed	Significant improvements in lung function, disease control, and health-related quality of life measures (p ≤ 0.002 for all) 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	Patients switching from other inhaler devices to the Easyhaler were more satisfied and achieved improved asthma, COPD, and ACO control in daily clinical practice in outpatient care
Piroźyński et al. [37]	Poland	To evaluate the clinical effectiveness of a second product (Bufomix Easyhaler) in the daily clinical practice of asthma therapy	Non-randomized, open-label, post-authorization efficacy study. Clinical assessment was conducted by 220 unselected allergologists and pulmonologists who enrolled 2200 adult outpatients (age 49.8 ± 17.9 years) with asthma treated with Bufomix Easyhaler for at least 14 days before enrolment	Asthma control was assessed during three subsequent visits at 8–12-week intervals on the basis of the Asthma Control Test (ACT). Adherence was assessed with the Medication Adherence Questionnaire. In addition, patient satisfaction with the Bufomix Easyhaler was scored, and adverse drug reactions were recorded	The percentage of patients with well-controlled asthma or total control of asthma (ACT score 20–25 points) increased from 46.6% at the first visit to 90.8% at the third visit (p < 0.001). In addition, the percentage of patients with poor control of asthma (ACT score < 15 points) decreased from 14.9 to 1.2% (p < 0.001). The adherence rate increased from 88% at the first visit to 95.3% at the third visit. Patient satisfaction with the use of this dry-powder inhaler increased with the duration of its use	Easyhaler demonstrated good clinical efficacy and improved disease control among adult asthma patients in daily clinical practice in outpatient care
Price et al. [36]	UK	To investigate the clinical and cost-effectiveness of switching real-life asthma patients from other types of inhaler to the Easyhaler (EH) for the administration of inhaled corticosteroids (ICS)	Historical, matched-cohort study of 1958 asthma patients (children and adults) treated in UK primary-care practices, using data obtained from the Optimum Patient Care Research Database and Clinical Practice Research Datalink. Other inhalers (OH) included pressurized metered-dose inhalers, breath-actuated inhalers and dry-powder inhalers delivering beclomethasone, budesonide, fluticasone, or ciclesonide	Patients who remained on OH unchanged (same drug, dosage and device; n = 979) were matched 1:1 with those who switched to the EH (beclomethasone or budesonide) at the same or lower ICS dosage (n = 979), based on age, sex, year of index patient review/switch, most recent ICS drug, dosage and device and the number of severe exacerbations and average daily short-acting β2 agonist (SABA) dosage in the preceding year. Clinical outcomes and healthcare costs were compared between groups for 12 months before and after the switch	Non-inferiority was shown for the EH for all four co-primary outcomes. There were no significant differences between groups for risk domain asthma control or exacerbation rates, but EH patients were significantly more likely to achieve overall asthma control (adjusted odds ratio [95% confidence interval] 1.26 [1.05–1.52]), as significantly more EH than OH patients had an average SABA dosage of ≤ 200 μg/day (52 vs. 47%; p < 0.001)	Asthma patients may be switched from other ICS devices to Easyhaler with no reduction in clinical effectiveness or increase in healthcare costs
Gálffy et al. [34]	Hungary	Real-world study aimed to evaluate the effectiveness of budesonide/formoterol fumarate (B/F) Easyhaler in everyday clinical practice in Hungary	Post hoc, subgroup analyses of this 12-week, real-world, multicenter, open-label study were conducted in adults diagnosed with asthma or COPD. In total, 398 and 563 patients with asthma and COPD, respectively, were analyzed	Endpoints included the change in patient-reported outcome measures, i.e., symptoms and disease control measured by the Asthma Control Test or COPD Assessment Test and health-related quality of life (HRQoL) measured by mini-Asthma Quality of Life Questionnaire or modified Medical Research Council dyspnoea scale. Changes in lung function and patient satisfaction with B/F Easyhaler versus previous inhaler were also evaluated. Results were stratified by the inhaler device used at visit 1 (baseline, when patients switched device); comparisons were made with B/F Easyhaler use after 12 weeks, assessed at visit 3	Significant improvements (p < 0.0001) in symptoms and disease control, HRQoL, and lung function were reported 12 weeks after switching treatment to B/F Easyhaler from the most commonly used devices (≥ 10% of patients). Significant increases in patient satisfaction were also reported versus comparators	The use of the Easyhaler is easy to teach. Patients are highly satisfied with the Easyhaler and regard it as easy to learn to use