Research

Efficacy and Onset of Action of Mometasone Furoate/Formoterol and Fluticasone Propionate/Salmeterol Combination Treatment in Subjects With Persistent Asthma

David I. Bernstein, Jacques Hebert, Amarjit Cheema, Kevin R. Murphy, Ivan Cherrez-Ojeda, Carlos Eduardo Matiz-Bueno, Wen-Ling Kuo and Hendrik Nolte

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Allergy, Asthma & Clinical Immunology 2011, 7:21 doi:10.1186/1710-1492-7-21

Published: 7 December 2011

Abstract (provisional)

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 mcg (delivered as 2 inhalations of MF-MDI 100 mcg) twice daily (BID), subjects (aged 12 or more years) were randomized to MF/F-MDI 200/10 mcg BID (delivered as 2 inhalations of MF/F-MDI 100/5 mcg) or FP/S administered via a dry powder inhaler (DPI) 250/50 mcg (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 AUC0-12h). 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 AUC0-12h change from baseline at week 12 for MF/F-MDI and FP/S-DPI was 3.43 and 3.24 L x 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. Trial registration: ClinicalTrials.gov Identifier, NCT00424008