Bernstein, David I

Murphy, Kevin R

Nolte, Hendrik

English

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David I Bernstein

Kevin R Murphy

Hendrik Nolte

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Allergy Asthma & Clinical Immunology

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

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POSTER PRESENTATION Open Access
Non-inferiority efficacy comparison of
mometasone furoate/formoterol versus
fluticasone propionate/salmeterol combination
therapies in subjects with persistent asthma
David I Bernstein1, Kevin R Murphy2*†, Hendrik Nolte3
From Canadian Society of Allergy and Clinical Immunology Annual Scientific Meeting 2010
Victoria, Canada. 4-7 November 2010
Background
Mometasone furoate/formoterol (MF/F) combination
therapy is a new treatment for persistent asthma. We
report findings from a non-inferiority study that com-
pared effects of MF/F and fluticasone propionate/salme-
terol (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 b2-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 post-
dose (FEV1AUC0-12 h). Key secondary endpoints
included onset of action, defined as change from base-
line 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 signifi-
cantly 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).
Conclusions
This non-inferiority trial demonstrated that MDI-admi-
nistered 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.
* Correspondence: Kevin.Murphyboystown.org
† Contributed equally
2Boys Town National Research Hospital, Boys Town, NE, 68130, USA
Full list of author information is available at the end of the article
Figure 1 Onset of action for MF/F-MDI vs FP/S-DPI
combination therapies.
Bernstein et al. Allergy, Asthma and Clinical Immunology 2010, 6(Suppl 2):P33
http://www.aacijournal.com/content/6/S2/P33 ALLERGY, ASTHMA & CLINICAL 
IMMUNOLOGY
© 2010 Bernstein et al; licensee BioMed Central Ltd.
Author details
1University of Cincinnati College of Medicine, Cincinnati, OH, 45267, USA.
2Boys Town National Research Hospital, Boys Town, NE, 68130, USA. 3Merck
Research Laboratories, Kenilworth, NJ, 07033, USA.
Published: 22 December 2010
doi:10.1186/1710-1492-6-S2-P33
Cite this article as: Bernstein et al.: Non-inferiority efficacy comparison
of mometasone furoate/formoterol versus fluticasone propionate/
salmeterol combination therapies in subjects with persistent asthma.
Allergy, Asthma and Clinical Immunology 2010 6(Suppl 2):P33.
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Bernstein et al. Allergy, Asthma and Clinical Immunology 2010, 6(Suppl 2):P33
http://www.aacijournal.com/content/6/S2/P33
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Non-inferiority efficacy comparison of mometasone furoate/formoterol versus fluticasone propionate/salmeterol combination therapies in subjects with persistent asthma

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