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

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dc.contributor.authorCukier, Alberto
dc.contributor.authorJacob, Cristina Miuki Abe [UNIFESP]
dc.contributor.authorRosario Filho, Nelson Augusto
dc.contributor.authorFiterman, Jussara
dc.contributor.authorVianna, Elcio Oliveira
dc.contributor.authorHetzel, Jorge Lima
dc.contributor.authorNeis, Marcio Abreu
dc.contributor.authorFiss, Elie
dc.contributor.authorCastro, Fábio Fernandes Morato
dc.contributor.authorFernandes, Ana Luisa Godoy [UNIFESP]
dc.contributor.authorStirbulov, Roberto
dc.contributor.authorPizzichini, Emilio
dc.contributor.authorAIR Brazilian Study Grp
dc.contributor.institutionUniversidade de São Paulo (USP)
dc.contributor.institutionUniv Fed Parana
dc.contributor.institutionPontificia Univ Catolica Rio Grande do Sul
dc.contributor.institutionUniv S Paulo
dc.contributor.institutionSanta Casa Misericordia Porto Alegre
dc.contributor.institutionCtr Paulista Invest Clin
dc.contributor.institutionFac Med ABC
dc.contributor.institutionInst Pesquisa Clin Med Avancada
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionSanta Casa Sch Med Sci São Paulo
dc.contributor.institutionUniversidade Federal de Santa Catarina (UFSC)
dc.date.accessioned2016-01-24T14:34:18Z
dc.date.available2016-01-24T14:34:18Z
dc.date.issued2013-09-01
dc.description.abstractThis 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.en
dc.description.affiliationUniv São Paulo, Fac Med, Hosp Clin, Pulm Div,Heart Inst InCor, BR-05403000 São Paulo, Brazil
dc.description.affiliationState Univ São Paulo, Dept Pediat, BR-05403000 São Paulo, Brazil
dc.description.affiliationUniv Fed Parana, Dept Pediat, BR-80060240 Curitiba, Parana, Brazil
dc.description.affiliationPontificia Univ Catolica Rio Grande do Sul, Sao Lucas Hosp, Ctr Pesquisa Clin, BR-90610000 Porto Alegre, RS, Brazil
dc.description.affiliationUniv S Paulo, Med Sch Ribeirao Preto, BR-14049900 Ribeirao Preto, SP, Brazil
dc.description.affiliationSanta Casa Misericordia Porto Alegre, BR-90035074 Porto Alegre, RS, Brazil
dc.description.affiliationCtr Paulista Invest Clin, BR-04266010 São Paulo, Brazil
dc.description.affiliationFac Med ABC, BR-09061650 Santo Andre, SP, Brazil
dc.description.affiliationInst Pesquisa Clin Med Avancada, BR-05437000 São Paulo, Brazil
dc.description.affiliationUniversidade Federal de São Paulo, BR-04062023 São Paulo, Brazil
dc.description.affiliationSanta Casa Sch Med Sci São Paulo, BR-01221900 São Paulo, Brazil
dc.description.affiliationUniv Fed Santa Catarina, BR-88040970 Florianopolis, SC, Brazil
dc.description.affiliationUnifespUniversidade Federal de São Paulo, BR-04062023 São Paulo, Brazil
dc.description.sourceWeb of Science
dc.format.extent1330-1338
dc.identifierhttp://dx.doi.org/10.1016/j.rmed.2013.06.018
dc.identifier.citationRespiratory Medicine. London: W B Saunders Co Ltd, v. 107, n. 9, p. 1330-1338, 2013.
dc.identifier.doi10.1016/j.rmed.2013.06.018
dc.identifier.fileWOS000330271600006.pdf
dc.identifier.issn0954-6111
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/36664
dc.identifier.wosWOS:000330271600006
dc.language.isoeng
dc.publisherW B Saunders Co Ltd
dc.relation.ispartofRespiratory Medicine
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectAsthma control questionnaireen
dc.subjectClinical trialen
dc.subjectForced expiratory volume in 1 sen
dc.subjectSingle inhaleren
dc.subjectNon-inferiorityen
dc.subjectMorning peak expiratory flowen
dc.titleFluticasone/formoterol dry powder versus budesonide/formoterol in adults and adolescents with uncontrolled or partly controlled asthmaen
dc.typeinfo:eu-repo/semantics/article
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