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

Jaco Voorham (Corresponding Author), Nicolas Roche, Hicham Benhaddi, Marianka van der Tol, Victoria Carter, Job F. M. van Boven, Leif Bjermer, Marc Miravitlles, David B. Price

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)
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OBJECTIVES: Budesonide/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.

METHODS: Patients 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.

RESULTS: Comparing 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.

CONCLUSIONS: Among 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.

Original languageEnglish
Article numbere022051
Pages (from-to)1-12
Number of pages12
JournalBMJ Open
Issue number10
Early online date27 Oct 2018
Publication statusPublished - Oct 2018

Bibliographical note

Acknowledgements: The authors thank Derek Skinner, Francis Appiagyei and
Tanith Hjelmbjerg of the Observational and Pragmatic Research Institute for
providing assistance with data analysis. The authors also thank Ian Grieve and
Bill Watkins of Ashfield Healthcare Communications, part of UDG Healthcare, for
providing medical writing support. The authors thank Teva Pharmaceuticals for
providing a full review of the article.
Funding: This study was supported by Teva Pharmaceuticals and undertaken by
OPRI ( Medical writing support was funded by Teva Pharmaceuticals


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