Abstract
BackgroundThe long-acting β2-agonist (LABA) formoterol has an onset of effect comparable to that of salbutamol. Consequently, the combination of formoterol and budesonide in one inhaler, approved for maintenance use, can potentially be used for reliever therapy. This study compared the onset of relief from induced bronchospasm with a single dose of budesonide/formoterol versus standard salbutamol therapy in patients with asthma.MethodsIn this randomised, double-blind, placebo-controlled, cross-over study, 32 patients with asthma underwent a methacholine provocation test leading to a fall in forced expiratory volume in 1 second (FEV1) of ≥30% at enrolment (Visit 1) and three subsequent study visits (Visits 2–4). Immediately after each provocation at Visits 2–4, patients received one of three test treatments: one inhalation of budesonide/formoterol 160/4.5 μg (via Turbuhaler®), two inhalations of salbutamol 100 μg (via a pressurised metered-dose inhaler [pMDI]) or placebo. All patients received each of the test treatments in a randomised order, after separate methacholine provocations. The effect of treatment on FEV1 and breathlessness (using the Borg scale) was measured at 1, 3, 5, 10, 15, 20, 25 and 30 minutes after test treatment.ResultsFollowing methacholine provocation, Borg score increased from a baseline value of below 0.5 to 3.03, 3.31 and 3.50 before treatment with budesonide/formoterol, salbutamol and placebo, respectively. Budesonide/formoterol and salbutamol reversed methacholine-induced dyspnoea (breathlessness) rapidly. At 1 minute after inhalation, statistically significant decreases in Borg score were observed for budesonide/formoterol and salbutamol (p = 0.0233 and p < 0.0001, respectively, versus placebo), with similar rapid increases in FEV1 (both active treatments p < 0.0001 versus placebo). The median time to 50% recovery in Borg score after methacholine provocation was 3 minutes with budesonide/formoterol, 2 minutes with salbutamol and 10 minutes with placebo. All treatments and procedures were well tolerated.ConclusionSingle doses of budesonide/formoterol and salbutamol both provided rapid relief of dyspnoea and reversal of severe airway obstruction in patients with asthma with experimentally induced bronchoconstriction. The perception of relief, as confirmed by objective lung function assessment, provides evidence that budesonide/formoterol can be used as reliever medication in asthma.
Highlights
The long-acting β2-agonist (LABA) formoterol has an onset of effect comparable to that of salbutamol
Statistical analysis The primary efficacy outcome variable was the change in Borg score, which was defined as the difference between the Borg score obtained at the end of the methacholine provocation test and the Borg score obtained at 1 minute after drug administration
Efficacy Borg dyspnoea score increased from a baseline value of below 0.5 to post-provocation values of 3.03, 3.31 and 3.50 before administration of budesonide/formoterol, salbutamol and placebo, respectively
Summary
The long-acting β2-agonist (LABA) formoterol has an onset of effect comparable to that of salbutamol. Clinical studies show that use of budesonide/ formoterol for both maintenance and reliever therapy provides additional improvements in asthma control (assessed by symptoms and exacerbations) over the same maintenance therapy plus SABA for relief [14,15]. The effectiveness of this novel regimen, where patients use budesonide/formoterol as their only reliever medication, is thought to be the result of early intervention with rapid increases in ICS dose at the first signs of symptoms [16,17]
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