title: Efficacy and onset of action of mometasone furoate/formoterol and fluticasone propionate/salmeterol combination treatment in subjects with persistent asthma.
abstract: BACKGROUND
  Mometasone furoate/formoterol (MF/F) is a novel combination therapy for treatment of persistent asthma. This noninferiority trial compared the effects of MF/F and fluticasone propionate/salmeterol (FP/S) combination therapies on pulmonary function and onset of action in subjects with persistent asthma.
  
  
  METHODS
  Following a 2- to 4-week run-in period with MF administered via a metered-dose inhaler (MDI) 200 μg (delivered as 2 inhalations of MF-MDI 100 μg) twice daily (BID), subjects (aged ≥12 y) were randomized to MF/F-MDI 200/10 μg BID (delivered as 2 inhalations of MF/F-MDI 100/5 μg) or FP/S administered via a dry powder inhaler (DPI) 250/50 μg (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.
  
  
  RESULTS
  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 × 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]).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00424008.
authors.affiliation: Division of Immunology, Allergy and Rheumatology, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA. bernstdd@ucmail.uc.edu.
authors.forename: David I
authors.initials: DI
authors.lastname: Bernstein
authors.forename: Jacques
authors.initials: J
authors.lastname: Hébert
authors.forename: Amarjit
authors.initials: A
authors.lastname: Cheema
authors.forename: Kevin R
authors.initials: KR
authors.lastname: Murphy
authors.forename: Ivan
authors.initials: I
authors.lastname: Chérrez-Ojeda
authors.forename: Carlos Eduardo
authors.initials: CE
authors.lastname: Matiz-Bueno
authors.forename: Wen-Ling
authors.initials: WL
authors.lastname: Kuo
authors.forename: Hendrik
authors.initials: H
authors.lastname: Nolte