Table 2.
Observational studies reporting PROs and handling errors with Spiromax®, Turbuhaler®, and Easyhaler®
| Study | Design | Population | Duration | Objective | No. patients | Main findings |
|---|---|---|---|---|---|---|
| Giner et al. [15] | Observational, multicenter, international study | Adults with asthma or COPD | Single visit | To evaluate the appropriate use and PROs of BF Spiromax® and BF Turbuhaler® | N = 175 | • BF Spiromax® showed a lower total number of errors vs. BF Turbuhaler® (1.4 vs. 1.9; p < 0.001) and fewer handling errors (0.5 vs. 0.8; p < 0.001), respectively. |
| • BF Spiromax® is easier to learn how to use (p < 0,001), easier to prepare (p < 0,001), and comfortable in terms of weight and size (p < 0,001) and more patients felt that they were using the inhaler correctly (p < 0.001). | ||||||
| • BF Spiromax® was preferred by a greater number of patients (79.5%) over BF Turbuhaler®. | ||||||
| van der Palen et al. [42] | Observational, multicenter, international, cross-sectional study | Adults with asthma or COPD | Single visit | To evaluate adherence, satisfaction, and ease of use of BF Spiromax® | N = 1101 | • Overall, 72.5% showed medium-to-high adherence (MMAS-8 ≥ 6). |
| • Satisfaction was 8.9 (± 1.6) (scale from 1 to 10), with 98.8% being satisfied and 85.4% very satisfied. | ||||||
| • Ease of use was 9.1 (± 1.3) (scale 1 to 10). | ||||||
| Piedra Castro et al. [43], De Simón Gutiérrez et al. [44] | Observational, multicenter, national study | Patients with asthma and COPD | 3 months | To evaluate the efficacy, disease control, and satisfaction of BF Spiromax® vs. BF Turbuhaler® | N = 91 | • BF Spiromax® was superior in terms of disease control (ACT absolute mean effect 3.3 [95% CI − 0.4 to 2.8] p < 0.001 and CAT absolute mean effect − 4.34 [95% CI − 0.4 to 2.8], p < 0.001). |
| • BF Spiromax® was superior in terms of satisfaction: FSI-10 (in asthma, mean absolute effect 9.5 [95% CI 6.4–12.6], p < 0.001, and in COPD mean absolute effect of 10.4 [95% CI 6.87–14.01], p < 0.001). | ||||||
| • BF Spiromax® showed non-inferiority vs. BF Turbuhaler® in clinical efficacy according to FEV1. | ||||||
| Voorham et al. [45] | Observational, cohort, retrospective, case-matched study | Adults with asthma and COPD | 1 year | To evaluate non-inferiority in disease control after switching to BF Spiromax® vs. continuing with BF Turbuhaler® |
N = 385 Asthma N = 253 COPD N = 132 |
• BF Spiromax® was not inferior to BF Turbuhaler® in disease control (difference + 6.6%; [95% CI − 0.3 to 13.5]). |
| • Asthma patients using BF Spiromax® reported fewer exacerbations (RR 0.76; [95% CI 0.60–0.99] p = 0.044); were less likely to use high daily doses of SABA (OR 0.71; [95% CI 0.52–0.98; p = 0.034]); used fewer SABA inhalers (RR 0.92; [95% CI 0.86–0.99]; p = 0.019); and were more likely to achieve treatment stability (OR 1.44; 95% CI 1.02–2.04; p = 0.037). | ||||||
| • No significant differences were observed in COPD. | ||||||
| Gillissen et al. [47] | Prospective observational study | Adults with asthma and COPD | 12 weeks | To evaluate satisfaction, errors, disease control, and safety in patients who switched to BF Spiromax® |
N = 3943 Asthma N = 2707 COPD N = 1236 |
• The proportion of patients who were satisfied or very satisfied increased from 60.1 to 88.8%. |
| • A total of 62.1% of patients preferred BF Spiromax® over their old inhaler. | ||||||
| • Fewer handling errors were observed with BF Spiromax® (11.9% vs. 25.5%) vs. their old inhaler. | ||||||
| • The health status of 77.4% of patients improved. | ||||||
| • Disease severity improved according to clinicians and patients. | ||||||
| Roche et al. [48] | Prospective multicenter observational study | Adults with asthma | 12 weeks | To evaluate inhaler techniques, the relationship between critical errors and disease control, and factors related to device handling errors after switching to BF Spiromax® | N = 1435 | • Overall, 67% of patients used BF Spiromax® without handling errors and 88% without critical handling errors. |
| • Comorbidities were associated with handling errors, while concurrent illness that could affect device handling and prior training were associated with critical handling errors. | ||||||
| • Most patients (85.4%) preferred BF Spiromax® over their previous device (BF Turbuhaler® or Seretide® Diskus®). | ||||||
| • Levels of inadequately controlled-uncontrolled asthma were lower in patients using BF Spiromax® (8.6% vs. 64.6%), but higher in the presence of critical handling errors. |
COPD chronic obstructive pulmonary disease, PRO patient-reported outcome, BF budesonide and formoterol, MMAS-8 8-item Morisky medication adherence scale, ACT asthma control test, CI confidence interval, CAT COPD assessment test, FSI-10 feeling of satisfaction with inhaler questionnaire, FEV1 forced expiratory volume in 1 s, RR risk ratio, SABA short-acting beta-agonist, OR odds ratio