Abstract
BackgroundMometasone 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.MethodsFollowing 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.Results722 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]).ConclusionsThe 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.Trial registrationClinicalTrials.gov: NCT00424008
Highlights
Mometasone furoate/formoterol (MF/F) is a novel combination therapy for treatment of persistent asthma
The most recent inhaled corticosteroids (ICSs)/long-acting b2-agonist (LABA) combination therapy indicated for the treatment of persistent asthma is mometasone furoate/formoterol delivered via metered-dose inhaler (MF/F-MDI; Dulera®/Zenhale®, Schering Corporation, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ)
A long-term safety study [6] demonstrated that MF/FMDI 200/10 and 400/10 μg BID were well tolerated with safety profiles similar to equivalent doses of a commonly prescribed ICS/LABA combination, fluticasone propionate/salmeterol (FP/S; Advair®/Seritide®, GlaxoSmithKline, Research Triangle Park, NC)
Summary
Mometasone furoate/formoterol (MF/F) is a novel combination therapy for treatment of persistent asthma. The most recent ICS/LABA combination therapy indicated for the treatment of persistent asthma is mometasone furoate/formoterol delivered via metered-dose inhaler (MF/F-MDI; Dulera®/Zenhale®, Schering Corporation, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ). A long-term safety study [6] demonstrated that MF/FMDI 200/10 and 400/10 μg BID were well tolerated with safety profiles similar to equivalent doses of a commonly prescribed ICS/LABA combination, fluticasone propionate/salmeterol (FP/S; Advair®/Seritide®, GlaxoSmithKline, Research Triangle Park, NC). This 1-year safety study was not powered to compare MF/F and FP/S with regard to efficacy. If noninferiority was demonstrated, the trial was designed to investigate whether the onset of action with MF/F-MDI was faster than that with FP/S-DPI
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
