Real-world effectiveness evaluation of budesonide/formoterol Spiromax for the management of asthma and chronic obstructive pulmonary disease in the UK

Abstract

ObjectivesBudesonide/formoterol (BF) Spiromax® is an inhaled corticosteroid/long-acting β2-agonist fixed-dose combination (FDC) inhaler, designed to minimise common inhaler errors and provide reliable and consistent dose delivery in asthma and chronic obstructive pulmonary disease (COPD). We evaluated non-inferiority of BF Spiromax after changing from another FDC inhaler, compared with continuing the original inhaler.MethodsPatients with asthma and/or COPD who switched to BF Spiromax were matched (1:3) with non-switchers. Data were obtained from the Optimum Patient Care Research Database and Clinical Practice Research Datalink in the UK. The primary end point was the proportion of patients achieving disease control (using the risk domain control (RDC) algorithm); secondary end points were: exacerbation rate, short-acting β2-agonist (SABA) use and treatment stability (achieved RDC; no maintenance treatment change). Non-inferiority was defined as having 95% CI lower bound above −10%, using conditional logistic regression and adjusted for relevant confounders.ResultsComparing 385 matched patients (asthma 253; COPD 132) who switched to BF Spiromax with 1091 (asthma 743; COPD 348) non-switchers, non-inferiority of BF Spiromax in RDC was demonstrated (adjusted difference: +6.6%; 95% CI –0.3 to 13.5). Among patients with asthma, switchers to BF Spiromax versus BF Turbuhaler® reported fewer exacerbations (adjusted rate ratio (RR) 0.76;95% CI 0.60 to 0.99; p=0.044); were less likely to use high daily doses of SABA (adjusted OR 0.71;95% CI 0.52 to 0.98; p=0.034); used fewer SABA inhalers (adjusted RR 0.92;95% CI 0.86 to 0.99; p=0.019); and were more likely to achieve treatment stability (adjusted OR 1.44;95% CI 1.02 to 2.04; p=0.037). No significant differences in these end points were seen among patients with COPD.ConclusionsAmong UK patients with asthma and COPD, real-world use of BF Spiromax was non-inferior to BF Turbuhaler in terms of disease control. Among patients with asthma, switching to BF Spiromax was associated with reduced exacerbations, reduced SABA use and improved treatment stability versus continuing on BF Turbuhaler.

Budesonide/formoterol via the Elpenhaler® device in asthmatic patients: A real-world effectiveness study (The BOREAS Study)

“…Exacerbations were documented in just over 1% (14/1230) of the participants. Despite an annualized rate could not be objectively calculated due to the 6 months follow-up, the projected rate of exacerbations of any severity is in alignment with the range noted from other interventional and observational studies 22,[30][31][32][33] . Contrary to the findings of certain randomized trials with high-dose ICS, metanalyses of interventional and observational studies concluded that fewer exacerbations occur with a fixeddose combination of ICS/LABA than with an ICS alone 34,35 .…”

Narrative Review of the Role of Patient-Reported Outcomes and Inhaler Handling Errors in the Control of Asthma and COPD

“…The authors concluded that the use of BF Spiromax ® in routine clinical practice by patients with asthma and COPD was not inferior to BF Turbuhaler ® in terms of disease control. Asthma patients who switched to BF Spiromax ® showed reduced exacerbations, lower SABA use, and greater treatment stability compared with those who continued BF Turbuhaler ® [45,46].…”