Combination ICS/fast-onset LABA inhaler as maintenance and reliever therapy: the future for uncontrolled adult asthma?

Abstract

In the Single combination inhaler as Maintenance And Reliever Therapy (SMART) regimen, asthma patients use a corticosteroid/fast-onset long-acting beta-agonist inhaler as both regular maintenance and reliever therapy. In this multicenter, double-blind randomized controlled trial, Papi et al. have demonstrated that treatment with the combination beclometasone/formoterol hydrofluoroalkane (HFA)-MDI when used as both maintenance and reliever therapy significantly prolongs the time to the first severe asthma exacerbation and reduces severe exacerbations compared with the same fixed dose of maintenance beclometasone/formoterol HFA-MDI with salbutamol MDI for relief. These findings are consistent with those of the prior studies of the SMART regimen with the budesonide/formoterol DPI and extend the evidence for use of the SMART regimen to the extrafine beclometasone/formoterol HFA-MDI, to patients with high baseline reliever use, and to patients in whom the SMART regimen results in a step up, step down or no change in baseline inhaled corticosteroid dose.

Keywords::

• asthma
• beclometasone
• budesonide
• formoterol
• inhaled corticosteroid
• long-acting beta-agonist
• maintenance
• reliever
• SMART

Financial & competing interests disclosure

M Patel, J Pilcher and R Beasley have been involved in clinical research of the budesonide/formoterol SMART regimen, funded by the Health Research Council of New Zealand (a government funding organization). R Beasley has been a member of the GlaxoSmithKline (NZ) advisory board, consulted for Cytos Biotechnology and Pharmaxis, received research grants from AstraZeneca, Cephalon, Chiesi, Genentech, GlaxoSmithKline and Novartis, payment for lectures or support to attend meetings from Boehringer Ingelheim, GlaxoSmithKline, Novartis, Nycomed and Otsuka Pharmaceuticals. J Pilcher is a Health Research Council of New Zealand Clinical Research Training Fellow. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• • The conventional treatment for adult patients with moderate to severe asthma or poor asthma control is a combination inhaled corticosteroid (ICS)/long-acting beta-agonist inhaler for maintenance treatment with a short-acting beta-agonist for relief.

• • Prior studies have demonstrated that the budesonide/formoterol Single combination inhaler as Maintenance And Reliever Therapy regimen has greater efficacy in reducing severe asthma exacerbations, including those requiring hospitalization or emergency department attendance, than the same fixed dose of maintenance budesonide/formoterol with short-acting beta-agonist for relief, in adult patients with poor control.

• • This current study demonstrates that the use of the extrafine beclometasone/formoterol hydrofluoroalkane-metered dose inhaler (MDI) as maintenance and reliever therapy has greater efficacy in reducing severe exacerbations than the same fixed dose of beclometasone/formoterol hydrofluoroalkane-MDI with salbutamol for relief.

• • Severe asthma exacerbations, including those requiring hospitalization or emergency department visits, were reduced by approximately a third by treatment with beclometasone/formoterol as maintenance and reliever therapy.

• • The Single combination inhaler as Maintenance And Reliever Therapy regimen, used with either budesonide/formoterol dry powder inhaler or MDI or beclometasone/formoterol MDI, provides an alternative treatment option for use in adult patients at risk of severe exacerbations or patients with poor asthma control.

• • Investigation of the use of an ICS/fast-onset long-acting beta-agonist inhaler solely as reliever therapy in intermittent or persistent mild asthma is a research priority.