Avalia？？o da eficácia e seguran？a da associa？？o de budesonida e formoterol em dose fixa e cápsula única no tratamento de asma n？o controlada: ensaio clínico randomizado, duplo-cego, multicêntrico e controlado

objective: to evaluate the efficacy and safety of a fixed-dose, single-capsule budesonide-formoterol combination, in comparison with budesonide alone, in patients with uncontrolled asthma. methods: this was a randomized, double-blind, multicenter, phase iii, parallel clinical trial, comparing the short-term efficacy and safety of the combination of budesonide (400 μg) and formoterol (12 μg), with those of budesonide alone (400 μg), both delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma. the age of the patients ranged from 18 to 77 years. after a run-in period of 4 weeks, during which all of the patients received budesonide twice a day, they were randomized into one of the treatment groups. for 12 weeks. the treatment consisted of the administration of the medications twice a day for 12 weeks. the primary outcome measures were fev1, fvc, and morning pef. we performed an intention-to-treat analysis of the data. results: in comparison with the budesonide-only group patients, those treated with the budesonide-formoterol combination showed a significant improvement in fev1 (0.12 l vs. 0.02 l; p = 0.0129) and morning pef (30.2 l/min vs. 6.3 l/min; p = 0.0004). these effects were accompanied by good tolerability and safety, as demonstrated by the low frequency of adverse events, only minor adverse events having occurred. conclusions: the single-capsule combination of budesonide and formoterol appears to be efficacious and safe. our results indicate that this formulation is a valid therapeutic option for obtaining and maintaining asthma control. (clinicaltrials.gov identifier: nct01676987 [http://www.clinicaltrials.gov/])