%0 Journal Article
%T Step-down from high dose fixed combination therapy in asthma patients: a randomized controlled trial
%A Alberto Papi
%A Gabriele Nicolini
%A Nunzio Crimi
%A Leonardo M Fabbri
%A Dario Olivieri
%A Andrea Rossi
%A Pierluigi Paggiaro
%J Respiratory Research
%D 2012
%I BioMed Central
%R 10.1186/1465-9921-13-54
%X This was a prospective, randomised, controlled, two-arm parallel group study. Asthmatic patients who were fully controlled with a high daily dose (1000/100£¿¦Ìg) of fluticasone/salmeterol were randomly assigned to 6£¿months of open-label treatment with either 500/100£¿¦Ìg fluticasone/salmeterol Diskus daily or 400/24£¿¦Ìg extrafine beclomethasone/formoterol pMDI daily. The primary outcome was the change in morning peak expiratory flow (PEF) values between baseline and the end of treatment. The secondary outcomes included asthma control and exacerbation frequency.Four hundred twenty-two patients were included in the analysis. The PEF values remained above 95% of the predicted values throughout the study. The end-study morning PEF rates showed equivalence between the groups (difference between means, 2.49£¿L/min; 95% CI, -13.43 to 18.42). No changes from baseline were detected in PEF and forced expiratory volume in 1 second measured at the clinics, in the symptom scores or in the use of rescue medication. Asthma control was maintained in 95.2% of the patients at 6£¿months. No significant differences between the groups were detected in any other parameter, including exacerbation frequency and adverse events.Stepping down patients whose asthma is controlled with the highest recommended dose of fluticasone/salmeterol to either 500/100£¿¦Ìg fluticasone/salmeterol daily or 400/24£¿¦Ìg extra-fine beclomethasone/formoterol daily provides comparable maintenance of lung function and asthma control.clinicaltrials.gov NCT00497237
%K Beclomethasone
%K Extrafine
%K Fluticasone
%K Formoterol
%K Salmeterol
%U http://respiratory-research.com/content/13/1/54/abstract