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Non-inferiority efficacy comparison of mometasone furoate/formoterol versus fluticasone propionate/salmeterol combination therapies in subjects with persistent asthma

Contributed equally
Allergy, Asthma & Clinical Immunology20106 (Suppl 2) :P33

https://doi.org/10.1186/1710-1492-6-S2-P33

  • Published:

Keywords

  • Asthma
  • Corticosteroid
  • Primary Endpoint
  • Pulmonary Function
  • Secondary Endpoint

Background

Mometasone furoate/formoterol (MF/F) combination therapy is a new treatment for persistent asthma. We report findings from a non-inferiority study that compared effects of MF/F and fluticasone propionate/salmeterol (FP/S) combination therapies on pulmonary function and onset of action in subjects with persistent asthma.

Materials and methods

This randomized, active-controlled, multicenter, non-inferiority trial enrolled subjects (≥12 yrs) previously treated with medium-dose inhaled corticosteroid alone or combined with a long-acting β2-agonist. Following a 2-4 wk run-in treatment period with MF administered via metered-dose inhaler (MDI) 200 μg twice daily (BID), eligible subjects were randomized to MF/F-MDI 200/10 μg BID or FP/S administered via dry-powder inhaler (DPI) 250/50 μg BID for 12 wks. The primary endpoint was change from baseline in area under the curve in forced expiratory volume in 1 s 0-12 h postdose (FEV1AUC0-12 h). Key secondary endpoints included onset of action, defined as change from baseline in FEV1 at 5 min postdose on Day 1.

Results

722 subjects were randomized to MF/F-MDI (n = 371) or FP/S-DPI (n = 351). MF/F-MDI was found to be non-inferior to FP/S-DPI for mean FEV1AUC0-12 h at endpoint (3.43 vs 3.24 Lxh, respectively; 95% CI, -0.40, 0.76). MF/F-MDI's onset of action was rapid and significantly faster than observed for FP/S-DPI (Figure 1), with a 200 mL mean increase from baseline in FEV1 at 5 min postdose (first scheduled measurement) on Day 1 for MF/F-MDI vs 90 mL for FP/S-DPI (P < 0.001).
Figure 1
Figure 1

Onset of action for MF/F-MDI vs FP/S-DPI combination therapies.

Conclusions

This non-inferiority trial demonstrated that MDI-administered MF/F 200/10 μg BID was non-inferior to DPI-administered FP/S 250/50 μg BID in FEV1AUC0-12 h. MF/F-MDI was superior to FP/S-DPI in onset of action.

Notes

Authors’ Affiliations

(1)
University of Cincinnati College of Medicine, Cincinnati, OH 45267, USA
(2)
Boys Town National Research Hospital, Boys Town, NE 68130, USA
(3)
Merck Research Laboratories, Kenilworth, NJ 07033, USA

Copyright

© Bernstein et al; licensee BioMed Central Ltd. 2010

This article is published under license to BioMed Central Ltd.

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