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

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dc.contributor.authorCukier, A.
dc.contributor.authorJacob, C. M. A. [UNESP]
dc.contributor.authorRosario Filho, N. A.
dc.contributor.authorFiterman, J.
dc.contributor.authorVianna, E. O.
dc.contributor.authorHetzel, J. L.
dc.contributor.authorNeis, M. A.
dc.contributor.authorFiss, E.
dc.contributor.authorCastro, F. F. M.
dc.contributor.authorFernandes, A. L. G.
dc.contributor.authorStirbulov, R.
dc.contributor.authorPizzichini, E.
dc.contributor.institutionUniversidade de São Paulo (USP)
dc.contributor.institutionUniversidade Estadual Paulista (Unesp)
dc.contributor.institutionUniversidade Federal do Paraná (UFPR)
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 Sao Paulo
dc.contributor.institutionUniversidade Federal de Santa Catarina (UFSC)
dc.date.accessioned2014-12-03T13:08:46Z
dc.date.available2014-12-03T13:08:46Z
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 Ltd. All rights reserved.en
dc.description.affiliationUniv Sao Paulo, Fac Med, Hosp Clin, Pulm Div,Heart Inst InCor, BR-05403000 Sao Paulo, Brazil
dc.description.affiliationState Univ Sao Paulo, Dept Pediat, BR-05403000 Sao 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 Sao Paulo, Brazil
dc.description.affiliationFac Med ABC, BR-09061650 Santo Andre, SP, Brazil
dc.description.affiliationInst Pesquisa Clin Med Avancada, BR-05437000 Sao Paulo, Brazil
dc.description.affiliationUniv Fed Sao Paulo, BR-04062023 Sao Paulo, Brazil
dc.description.affiliationSanta Casa Sch Med Sci Sao Paulo, BR-01221900 Sao Paulo, Brazil
dc.description.affiliationUniv Fed Santa Catarina, BR-88040970 Florianopolis, SC, Brazil
dc.description.affiliationUnespState Univ Sao Paulo, Dept Pediat, BR-05403000 Sao Paulo, Brazil
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://hdl.handle.net/11449/111558
dc.identifier.wosWOS:000330271600006
dc.language.isoeng
dc.publisherW B Saunders Co Ltd
dc.relation.ispartofRespiratory Medicine
dc.relation.ispartofjcr3.230
dc.relation.ispartofsjr1,472
dc.rights.accessRightsAcesso aberto
dc.sourceWeb of Science
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.typeArtigo
dcterms.rightsHolderW B Saunders Co Ltd
unesp.author.orcid0000-0002-8550-8051[3]
unesp.author.orcid0000-0003-3910-6016[10]
unesp.author.orcid0000-0002-7217-9498[1]
unesp.author.orcid0000-0003-1902-6326[5]
unesp.author.orcid0000-0002-6211-5773[9]
unesp.author.orcid0000-0001-7046-9996[12]

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