Fluticasone/formoterol dry powder versus budesonide/formoterol in adults and adolescents with uncontrolled or partly controlled asthma - 22/08/13

Doi : 10.1016/j.rmed.2013.06.018

A. Cukier ^a, C.M.A. Jacob ^b, N.A. Rosario Filho ^c, J. Fiterman ^d, E.O. Vianna ^e, J.L. Hetzel ^f, M.A. Neis ^g, E. Fiss ^h, F.F.M. Castro ⁱ, A.L.G. Fernandes ^j, R. Stirbulov ^k, E. Pizzichini ^l,^⁎
AIR Brazilian Study Group
^a Pulmonary Division, Heart Institute (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Av. Dr. Eneas de Carvalho Aguiar, 44 – bloco I – 1° andar, São Paulo, SP 05403-000, Brazil
^b Department of Pediatrics, State University of São Paulo, Av. Dr. Eneas Carvalho de Aguiar, 647, P1/P2, São Paulo, SP 05403-000, Brazil
^c Departamento of Pediatrics, Federal University of Paraná, Rua Padre Camargo, 530 – 1° andar, Curitiba, PR 80060-240, Brazil
^d Pontifical Catholic University of Rio Grande do Sul – São Lucas Hospital, Av. Ipiranga, 6990 – 4° andar – centro de pesquisa clinica, Porto Alegre, RS 90610-000, Brazil
^e Medical School of Ribeirão Preto, University of S. Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, SP 14049-900, Brazil
^f Santa Casa de Misericordia de Porto Alegre, Av. Independência, 75 – Pavilhão Pereira Filho – 1° andar, Porto Alegre, RS 90035-074, Brazil
^g Centro Paulista de Investigação Clínica, Rua Moreira e Costa, 342 – Ipiranga, Sâo Paulo, SP 04266-010, Brazil
^h Faculdade de Medicina ABC, Avenida Principe de Gales, 821, Santo André, SP 09061650, Brazil
ⁱ Instituto de Pesquisa Clínica Medicina Avançada, Praça Américo Jacomino, 55, Vila Madalena, São Paulo, SP 05437-000, Brazil
^j Federal University of São Paulo, Rua Botucatu, 740 – 3° andar – Vila Clementino, São Paulo, SP 04062-023, Brazil
^k Santa Casa School of Medical Sciences in São Paulo, Rua Dr. Cesário Mota Junior, 112 – UPCOR – sala 1, São Paulo, SP 01221-900, Brazil
^l Federal University of Santa Catarina, Campus Universitário – Trindade, Florianópolis, SC 88040-970, Brazil

^∗Corresponding author. Tel.: +55 48 3234 7711, +55 48 9971 8273 (mobile).

Summary

This 12-week study compared the efficacy and safety of a fixed combination of fluticasone propionate plus formoterol (FL/F) 250/12 μg b.i.d. administered via a dry powder inhaler (DPI) (Libbs Farmacêutica, Brazil) to a combination of budesonide plus formoterol (BD/F) 400/12 μg 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).

Le texte complet de cet article est disponible en PDF.

Keywords : Asthma control questionnaire, Clinical trial, Forced expiratory volume in 1 s, Single inhaler, Non-inferiority, Morning peak expiratory flow

Plan

Protocol outcome measures

☆

Conducted by Asthma Inhaled Research (AIR): comparing fluticasone propionate combined with formoterol versus Symbicort^® – AIR Brazilian Study Group.^{^{1
AIR Brazilian Study Group members include: Ana Carla S. Araujo, Anna Beatriz Naumes, Andrea Gimenez, Antonio Carlos Pastorino, Carlos Toufen Junior, Claudia Loss Reck, Clóvis Eduardo Santos Galvão, Daniela Cavalet Blanco, Debora Carla Chong e Silva, Denise A. Padilha Kroth, Fabiane Kahan, Fernanda Spilimbergo, Herberto José Chong Neto, José Roberto Jardim, Lilian Ballina Caetano, Manuela Cavalcanti, Marcia M.M. Pizzichini, Leila Marques Steidle, Rodrigo Athanazio, Samia Rached, Samir Drocoulaks, Sonia Maria Foresin, Suzana Zelmanovitz, Valéria Cristina V. Martins.}}

Export

Vol 107 - N° 9

P. 1330-1338 - septembre 2013 Retour au numéro

Article précédent

Sublingual immunotherapy in children with allergic rhinoconjunctivitis mono-sensitized to house-dust-mites: A double-blind-placebo-controlled randomised trial
Metin Aydogan, Aarif O. Eifan, Sevgi Keles, Tunc Akkoc, Mustafa A. Nursoy, Nerrin N. Bahceciler, Isil B. Barlan

| Article suivant

Vascular endothelial growth factor and cysteinyl leukotrienes in sputum supernatant of patients with asthma
Georgia Papadaki, Petros Bakakos, Konstantinos Kostikas, Georgios Hillas, Zoi Tsilogianni, Nikolaos G. Koulouris, Spyros Papiris, Stelios Loukides

Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.

Déjà abonné à cette revue ?

connectez-vous ou créez un compte

Fluticasone/formoterol dry powder versus budesonide/formoterol in adults and adolescents with uncontrolled or partly controlled asthma - 22/08/13

Summary

Plan

Export citations

Fichier

Contenu

Accès rapides

Mon compte

Aide & support

Plateformes Elsevier Masson

Déclaration CNIL