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    Fluticasone/formoterol dry powder versus budesonide/formoterol in adults and adolescents with uncontrolled or partly controlled asthma
    (W B Saunders Co Ltd, 2013-09-01) Cukier, Alberto; Jacob, Cristina Miuki Abe [UNIFESP]; Rosario Filho, Nelson Augusto; Fiterman, Jussara; Vianna, Elcio Oliveira; Hetzel, Jorge Lima; Neis, Marcio Abreu; Fiss, Elie; Castro, Fábio Fernandes Morato; Fernandes, Ana Luisa Godoy [UNIFESP]; Stirbulov, Roberto; Pizzichini, Emilio; AIR Brazilian Study Grp; Universidade de São Paulo (USP); Univ Fed Parana; Pontificia Univ Catolica Rio Grande do Sul; Univ S Paulo; Santa Casa Misericordia Porto Alegre; Ctr Paulista Invest Clin; Fac Med ABC; Inst Pesquisa Clin Med Avancada; Universidade Federal de São Paulo (UNIFESP); Santa Casa Sch Med Sci São Paulo; Universidade Federal de Santa Catarina (UFSC)
    This 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 B.V. All rights reserved.