dc.contributor | Universidade de São Paulo (USP) | |
dc.contributor | Univ Fed Parana | |
dc.contributor | Pontificia Univ Catolica Rio Grande do Sul | |
dc.contributor | Univ S Paulo | |
dc.contributor | Santa Casa Misericordia Porto Alegre | |
dc.contributor | Ctr Paulista Invest Clin | |
dc.contributor | Fac Med ABC | |
dc.contributor | Inst Pesquisa Clin Med Avancada | |
dc.contributor | Universidade Federal de São Paulo (UNIFESP) | |
dc.contributor | Santa Casa Sch Med Sci São Paulo | |
dc.contributor | Universidade Federal de Santa Catarina (UFSC) | |
dc.creator | Cukier, Alberto | |
dc.creator | Jacob, Cristina Miuki Abe [UNIFESP] | |
dc.creator | Rosario Filho, Nelson Augusto | |
dc.creator | Fiterman, Jussara | |
dc.creator | Vianna, Elcio Oliveira | |
dc.creator | Hetzel, Jorge Lima | |
dc.creator | Neis, Marcio Abreu | |
dc.creator | Fiss, Elie | |
dc.creator | Castro, Fábio Fernandes Morato | |
dc.creator | Fernandes, Ana Luisa Godoy [UNIFESP] | |
dc.creator | Stirbulov, Roberto | |
dc.creator | Pizzichini, Emilio | |
dc.creator | AIR Brazilian Study Grp | |
dc.date.accessioned | 2016-01-24T14:34:18Z | |
dc.date.accessioned | 2022-10-07T20:39:28Z | |
dc.date.available | 2016-01-24T14:34:18Z | |
dc.date.available | 2022-10-07T20:39:28Z | |
dc.date.created | 2016-01-24T14:34:18Z | |
dc.date.issued | 2013-09-01 | |
dc.identifier | Respiratory Medicine. London: W B Saunders Co Ltd, v. 107, n. 9, p. 1330-1338, 2013. | |
dc.identifier | 0954-6111 | |
dc.identifier | http://repositorio.unifesp.br/handle/11600/36664 | |
dc.identifier | WOS000330271600006.pdf | |
dc.identifier | 10.1016/j.rmed.2013.06.018 | |
dc.identifier | WOS:000330271600006 | |
dc.identifier.uri | http://repositorioslatinoamericanos.uchile.cl/handle/2250/4020704 | |
dc.description.abstract | 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. | |
dc.language | eng | |
dc.publisher | W B Saunders Co Ltd | |
dc.relation | Respiratory Medicine | |
dc.rights | Acesso aberto | |
dc.subject | Asthma control questionnaire | |
dc.subject | Clinical trial | |
dc.subject | Forced expiratory volume in 1 s | |
dc.subject | Single inhaler | |
dc.subject | Non-inferiority | |
dc.subject | Morning peak expiratory flow | |
dc.title | Fluticasone/formoterol dry powder versus budesonide/formoterol in adults and adolescents with uncontrolled or partly controlled asthma | |
dc.type | Artigo | |