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

dc.contributorUniversidade Estadual Paulista (UNESP)
dc.creatorCukier, A.
dc.creatorJacob, C. M. A.
dc.creatorRosario Filho, N. A.
dc.creatorFiterman, J.
dc.creatorVianna, E. O.
dc.creatorHetzel, J. L.
dc.creatorNeis, M. A.
dc.creatorFiss, E.
dc.creatorCastro, F. F. M.
dc.creatorFernandes, A. L. G.
dc.creatorStirbulov, R.
dc.creatorPizzichini, E.
dc.creatorAIR Brazilian Study Grp
dc.date2014-12-03T13:08:46Z
dc.date2016-10-25T20:09:08Z
dc.date2014-12-03T13:08:46Z
dc.date2016-10-25T20:09:08Z
dc.date2013-09-01
dc.date.accessioned2017-04-06T06:14:10Z
dc.date.available2017-04-06T06:14:10Z
dc.identifierRespiratory Medicine. London: W B Saunders Co Ltd, v. 107, n. 9, p. 1330-1338, 2013.
dc.identifier0954-6111
dc.identifierhttp://hdl.handle.net/11449/111558
dc.identifierhttp://acervodigital.unesp.br/handle/11449/111558
dc.identifier10.1016/j.rmed.2013.06.018
dc.identifierWOS:000330271600006
dc.identifierWOS000330271600006.pdf
dc.identifierhttp://dx.doi.org/10.1016/j.rmed.2013.06.018
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/922334
dc.descriptionThis 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.
dc.languageeng
dc.publisherW B Saunders Co Ltd
dc.relationRespiratory Medicine
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectAsthma control questionnaire
dc.subjectClinical trial
dc.subjectForced expiratory volume in 1 s
dc.subjectSingle inhaler
dc.subjectNon-inferiority
dc.subjectMorning peak expiratory flow
dc.titleFluticasone/formoterol dry powder versus budesonide/formoterol in adults and adolescents with uncontrolled or partly controlled asthma
dc.typeOtro


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