Efficacy and safety of fluticasone and formoterol in a single pressurized metered dose inhaler.
Author(s): Bodzenta-Lukaszyk A, Pulka G, Dymek A, Bumbacea D, McIver T, Schwab B, Mansikka H
Affiliation(s): Department of Allergology and Internal Medicine, Medical University of Bialystok, M.Sklodowskiej-Curie 24 A, 15-276 Bialystok, Poland. firstname.lastname@example.org
Publication date & source: 2011-05, Respir Med., 105(5):674-82. Epub 2010 Dec 31.
Publication type: Comparative Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
BACKGROUND: Fluticasone and formoterol are well established medications for the treatment of asthma. This study (Clinicaltrials.gov identifier: NCT00734318) compares the efficacy and safety of a combination of these drugs in a single inhaler (fluticasone/formoterol) versus the individual components (fluticasone + formoterol). METHODS: Patients aged >/= 18 years (n=620) with a history of severe, persistent reversible asthma for >/= 6 months prior to screening were included in this randomized, double-blind study, which consisted of a screening phase of up to 5 days, a 2-week run-in phase and an 8-week treatment period. RESULTS: Fluticasone/formoterol (500/20 mug, b.i.d.) was at least as effective as fluticasone + formoterol (500 mug + 24 mug, b.i.d.) with respect to the primary outcome measure: there were similar increases in mean pre-morning dose forced expiratory volume in the first second (FEV(1)) in these two groups. Fluticasone/formoterol (500/20 mug, b.i.d.) also demonstrated similar efficacy to fluticasone + formoterol in terms of change in mean FEV(1) from baseline pre-morning dose to 2 h post-morning dose at week 8, as well as for several secondary parameters. Fluticasone/formoterol (500/20 mug, b.i.d.) demonstrated superiority to fluticasone monotherapy (500 mug, b.i.d.) and fluticasone/formoterol (100/10 mug, b.i.d.) for several secondary efficacy parameters. Fluticasone/formoterol had a similar safety and tolerability profile to fluticasone + formoterol. CONCLUSION: This study demonstrated that the fluticasone/formoterol combination is at least as effective as its components administered concurrently from separate inhalers. Fluticasone/formoterol (500/20 mug, b.i.d.) showed superior efficacy to its inhaled corticosteroid component alone and the efficacy of fluticasone/formoterol was dose-dependent for several clinically important parameters. Copyright (c) 2010 Elsevier Ltd. All rights reserved.