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Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone

2007; Elsevier BV; Volume: 101; Issue: 12 Linguagem: Inglês

10.1016/j.rmed.2007.07.014

1532-3064

Jean Bousquet, Louis‐Philippe Boulet, Matthew Peters, H Magnussen, J. Quiralte, Nora Ernestina Martínez-Aguilar, Åsa Carlsheimer,

Chronic Obstructive Pulmonary Disease (COPD) Research

BackgroundBudesonide/formoterol maintenance and reliever therapy (Symbicort SMART®) improves asthma control compared with fixed-dose inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) regimens, but its efficacy has not been assessed in comparison with sustained high-dose salmeterol/fluticasone (Seretide™) plus a short-acting β2-agonist (SABA).MethodsPatients (N=2309) with symptomatic asthma (aged ⩾12 years; forced expiratory volume in 1s ⩾50% predicted), who had experienced an asthma exacerbation in the previous year, were randomised to receive budesonide/formoterol 160/4.5μg two inhalations twice daily and as needed, or one inhalation of salmeterol/fluticasone 50/500μg twice daily plus terbutaline as needed, for 6 months.ResultsTime to first severe exacerbation, the pre-specified primary outcome, was not significantly prolonged (risk ratio 0.82; 95% confidence interval 0.63, 1.05). Budesonide/formoterol maintenance and reliever therapy reduced total exacerbations from 31 to 25 events/100 patients/year (P=0.039), and exacerbations requiring hospitalisation/emergency room (ER) treatment from 13 to 9 events/100 patients/year (P=0.046). The treatments showed no difference in measures of lung function or asthma symptoms. The mean dose of ICS received was lower using budesonide/formoterol maintenance and reliever therapy (792μg/day budesonide [1238μg/day beclomethasone dipropionate (BDP) equivalent] versus 1000μg/day fluticasone [2000μg/day BDP equivalent] with salmeterol/fluticasone therapy; P<0.0001). Both treatments were well tolerated.ConclusionIn the treatment of uncontrolled asthma, budesonide/formoterol maintenance and reliever therapy reduces the incidence of severe asthma exacerbations and hospitalisation/ER treatment with similar daily symptom control compared with sustained high-dose salmeterol/fluticasone plus SABA. This benefit is achieved with substantially less ICS exposure.