%0 Journal Article
%T Efficacy and onset of action of mometasone furoate/formoterol and fluticasone propionate/salmeterol combination treatment in subjects with persistent asthma
%A David I Bernstein
%A Jacques H¨¦bert
%A Amarjit Cheema
%A Kevin R Murphy
%A Ivan Ch¨¦rrez-Ojeda
%A Carlos Matiz-Bueno
%A Wen-Ling Kuo
%A Hendrik Nolte
%J Allergy, Asthma & Clinical Immunology
%D 2011
%I BioMed Central
%R 10.1186/1710-1492-7-21
%X Following a 2- to 4-week run-in period with MF administered via a metered-dose inhaler (MDI) 200 ¦Ìg (delivered as 2 inhalations of MF-MDI 100 ¦Ìg) twice daily (BID), subjects (aged ¡Ý12 y) were randomized to MF/F-MDI 200/10 ¦Ìg BID (delivered as 2 inhalations of MF/F-MDI 100/5 ¦Ìg) or FP/S administered via a dry powder inhaler (DPI) 250/50 ¦Ìg (delivered as 1 inhalation) BID for 12 weeks. The primary assessment was change from baseline to week 12 in area under the curve for forced expiratory volume in 1 second measured serially for 0-12 hours postdose (FEV1 AUC0-12 h). Secondary assessments included onset of action (change from baseline in FEV1 at 5 minutes postdose on day 1) and patient-reported outcomes.722 subjects were randomized to MF/F-MDI (n = 371) or FP/S-DPI (n = 351). Mean FEV1 AUC0-12 h change from baseline at week 12 for MF/F-MDI and FP/S-DPI was 3.43 and 3.24 L ¡Á h, respectively (95% CI, -0.40 to 0.76). MF/F-MDI was associated with a 200-mL mean increase from baseline in FEV1 at 5 minutes postdose on day 1, which was significantly larger than the 90-mL increase for FP/S-DPI (P < 0.001). The overall incidence of adverse events during the 12-week treatment period that were considered related to study therapy was similar in both groups (MF/F-MDI, 7.8% [n = 29]; FP/S-DPI, 8.3% [n = 29]).The results of this 12-week study indicated that MF/F improves pulmonary function and asthma control similar to FP/S with a superior onset of action compared with FP/S. Both drugs were safe, improved asthma control, and demonstrated similar results for other secondary study endpoints.ClinicalTrials.gov: NCT00424008Asthma is a chronic inflammatory disorder of the airways that results in recurrent coughing, chest tightness, wheezing, and breathlessness [1]. The first line of therapy to relieve symptoms of persistent asthma is inhaled corticosteroids (ICSs) [1,2]. However, when an ICS alone is unable to control persistent asthma, the Global Initiative for Asthma (GINA) [1] and the N
%K asthma
%K mometasone furoate/formoterol
%K fluticasone propionate/salmeterol
%K noninferiority
%K onset of action
%U http://www.aacijournal.com/content/7/1/21