Cukier, A.Jacob, C. M. A. [UNESP]Rosario Filho, N. A.Fiterman, J.Vianna, E. O.Hetzel, J. L.Neis, M. A.Fiss, E.Castro, F. F. M.Fernandes, A. L. G.Stirbulov, R.Pizzichini, E.2014-12-032014-12-032013-09-01Respiratory Medicine. London: W B Saunders Co Ltd, v. 107, n. 9, p. 1330-1338, 2013.0954-6111http://hdl.handle.net/11449/111558This 12-week study compared the efficacy and safety of a fixed combination of fluticasone propionate plus formoterol (FL/F) 250/12 mu g b.i.d. administered via a dry powder inhaler (DPI) (Libbs Farmaceutica, Brazil) to a combination of budesonide plus formoterol (BD/F) 400/12 mu g b.i.d. After a 2-week run-in period (in which all patients were treated exclusively with budesonide plus formoterol), patients aged 12-65 years of age (N = 196) with uncontrolled asthma were randomized into an actively-controlled, open-labeled, parallel-group, multicentre, phase III study. The primary objective was to demonstrate non-inferiority, measured by morning peak expiratory flow (mPEF).The non-inferiority was demonstrated. A statistically significant improvement from baseline was observed in both groups in terms of lung function, asthma control, and the use of rescue medication. FL/F demonstrated a statistical superiority to BD/F in terms of lung function (FEV1) (p = 0.01) and for asthma control (p = 0.02). Non-significant between-group differences were observed with regards to exacerbation rates and adverse events.In uncontrolled or partly controlled asthma patients, the use of a combination of fluticasone propionate plus formoterol via DPI for 12-weeks was non-inferior and showed improvements in FEV1 and asthma control when compared to a combination of budesonide plus formoterol. (Clinical Trial number: ISRCTN60408425). (C) 2013 Elsevier Ltd. All rights reserved.1330-1338engAsthma control questionnaireClinical trialForced expiratory volume in 1 sSingle inhalerNon-inferiorityMorning peak expiratory flowArtigo10.1016/j.rmed.2013.06.018WOS:000330271600006Acesso abertoWOS000330271600006.pdf