This article is more than 5 years old. Information may no longer be current.
Single inhaler as maintenance, reliever therapy viable for poorly controlled asthma
Patients with poorly controlled asthma at risk for exacerbations can benefit from a single combination inhaler maintenance and reliever therapy regimen, according to two studies published in The Lancet Respiratory Medicine.
In a multicenter, double blind study, researchers evaluated 1,701 patients with poorly controlled asthma. After a 2-week run-in period with 100 mcg beclometasone and 6 mcg formoterol twice daily, with as-needed 100 mcg salbutamol, patients were randomly assigned as-needed doses of 100 mcg beclometasone and 6 mcg formoterol (n=852) or 100 mcg salbutamol (n=849), in addition to twice-daily beclometasone and formoterol, for 48 weeks.
Severe exacerbations occurred in 251 patients on 326 occasions during the study, including 99 incidents in the beclometasone as-needed group and 152 in the salbutamol as-needed group. Time to initial exacerbation was longer in the beclometasone group (209 days compared with 134 days), with a lower estimated probability of occurrence (12% vs. 18%; P=.0003) and a 36% risk reduction compared with as-needed salbutamol (HR=0.64; 95% CI, 0.49-0.82).
In a separate multicenter study of the single combination inhaler maintenance and reliever therapy (SMART) regimen, researchers randomly assigned 303 patients to two doses of 200 mcg budesonide and 6 mcg formoterol twice daily via a metered-dose inhaler, with an extra actuation as needed (n=151) or two budesonide/formoterol actuations at the same dose with one to two 100 mcg salbutamol actuations as needed (n=152).
Participants receiving the SMART regimen experienced fewer severe asthma exacerbations (weighted mean 35 per year compared with 66; P=.004), and had fewer days of high use (mean 5.1 days vs. 8.9 days; P=.01). More patients in the SMART group reported at least one episode of high use (56% of cases vs. 45%; P=.058).
In an accompanying editorial, René Aalbers, MD, PhD, Martini Hospital, Groningen, Netherlands, wrote that the evidence presented is convincing for the use of a SMART regimen in patients with poorly controlled asthma at risk for exacerbations.
“Patel and Papi and their colleagues acknowledge SMART as a further treatment option and, therefore, we now have four options for a patient-tailored strategy of inhaled corticosteroid and a [long-acting beta2 agonist (LABA)]: fixed daily dose of inhaled corticosteroid and a LABA and as-needed [short-acting beta2 agonist (SABA)]; adjustable maintenance dosing; SMART; or inhaled corticosteroid, LABA and SABA as individual medications,” Aalbers wrote. “Despite these optionsfor treatment, we should start with a post-hoc analysis of the substantial patients’ data files from previous controlled trials with SMART and undertake real-life studies, including electronic monitoring, because we still do not know which patients will benefit most from which of these four treatment options.”
Disclosure: See the studies for full lists of relevant disclosures. Dr. Aalbers has served as a consultant for AstraZeneca, Chiesi and Mundipharma.