Abstract
BackgroundThe budesonide/formoterol combination is successfully used for fast relief of asthma symptoms in addition to its use as maintenance therapy. The temporarily increased corticosteroid dose during increasing inhaler use for symptom relief is likely to suppress any temporary increase in airway inflammation and may mitigate or prevent asthma exacerbations. The relative contribution of the budesonide and formoterol components to the improved asthma control is unclear.MethodsThe acute protective effect of inhaled budesonide was tested in a model of temporarily increased airway inflammation with repeated indirect airway challenges, mimicking an acute asthma exacerbation. A randomised, double-blind, cross-over study design was used. Asthmatic patients (n = 17, mean FEV1 95% of predicted) who previously demonstrated a ≥30% fall in forced expiratory volume in 1 second (FEV1) after inhaling adenosine 5'-monophosphate (AMP), were challenged on four consecutive test days, with the same dose of AMP (at 09:00, 12:00 and 16:00 hours). Within 1 minute of the maximal AMP-induced bronchoconstriction at 09:00 hours, the patients inhaled one dose of either budesonide/formoterol (160/4.5 μg), formoterol (4.5 μg), salbutamol (2 × 100 μg) or placebo. The protective effects of the randomised treatments were assessed by serial lung function measurements over the test day.ResultsIn the AMP provocations at 3 and 7 hours after inhalation, the budesonide/formoterol combination provided a greater protective effect against AMP-induced bronchoconstriction compared with formoterol alone, salbutamol and placebo. In addition all three active treatments significantly increased FEV1 within 3 minutes of administration, at a time when inhaled AMP had induced the 30% fall in FEV1.ConclusionsA single dose of budesonide/formoterol provided a greater protective effect against inhaled AMP-induced bronchoconstriction than formoterol alone, both at 3 and at 7 hours after inhalation. The acute protection against subsequent bronchoconstrictor stimuli such as inhaled AMP and the rapid reversal of airway obstruction supports the use of budesonide/formoterol for both relief and prevention in the treatment of asthma.Trial RegistrationClinicalTrials.gov number NCT00272753
Highlights
The budesonide/formoterol combination is successfully used for fast relief of asthma symptoms in addition to its use as maintenance therapy
Budesonide/ formoterol is effective in situations of acute and severe bronchoconstriction [8,9], indicating that it is effective as a reliever therapy
Clinical studies have substantiated that budesonide/formoterol can be used as both maintenance and reliever therapy, resulting in improved asthma control and an additional reduction in exacerbation frequency compared with maintenance therapy plus a separate bronchodilator for relief [10,11,12,13,14]
Summary
The budesonide/formoterol combination is successfully used for fast relief of asthma symptoms in addition to its use as maintenance therapy. Clinical studies have substantiated that budesonide/formoterol can be used as both maintenance and reliever therapy, resulting in improved asthma control and an additional reduction in exacerbation frequency compared with maintenance therapy plus a separate bronchodilator for relief [10,11,12,13,14]. The effectiveness of this novel treatment regimen, where patients use budesonide/formoterol as their only medication, is thought to be the result of a rapid increase in ICS dose at the earliest onset of symptoms [15]. An ICS has a vasoconstrictor effect in the airway mucosa, which can be measured within hours of administration [18]
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