Fluticasone/formoterol dry powder versus budesonide/formoterol in adults and adolescents with uncontrolled or partly controlled asthma

Made available in DSpace on 2014-12-03T13:08:46Z (GMT). No. of bitstreams: 0 Previous issue date: 2013-09-01Bitstream added on 2014-12-03T13:23:26Z : No. of bitstreams: 1 WOS000330271600006.pdf: 653705 bytes, checksum: 7169480c3bce90ef10850a2c11b21d68 (MD5) 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 Ltd. All rights reserved. Univ Sao Paulo, Fac Med, Hosp Clin, Pulm Div,Heart Inst InCor, BR-05403000 Sao Paulo, Brazil State Univ Sao Paulo, Dept Pediat, BR-05403000 Sao Paulo, Brazil Univ Fed Parana, Dept Pediat, BR-80060240 Curitiba, Parana, Brazil Pontificia Univ Catolica Rio Grande do Sul, Sao Lucas Hosp, Ctr Pesquisa Clin, BR-90610000 Porto Alegre, RS, Brazil Univ S Paulo, Med Sch Ribeirao Preto, BR-14049900 Ribeirao Preto, SP, Brazil Santa Casa Misericordia Porto Alegre, BR-90035074 Porto Alegre, RS, Brazil Ctr Paulista Invest Clin, BR-04266010 Sao Paulo, Brazil Fac Med ABC, BR-09061650 Santo Andre, SP, Brazil Inst Pesquisa Clin Med Avancada, BR-05437000 Sao Paulo, Brazil Univ Fed Sao Paulo, BR-04062023 Sao Paulo, Brazil Santa Casa Sch Med Sci Sao Paulo, BR-01221900 Sao Paulo, Brazil Univ Fed Santa Catarina, BR-88040970 Florianopolis, SC, Brazil State Univ Sao Paulo, Dept Pediat, BR-05403000 Sao Paulo, Brazil