Volume 6 Supplement 2

Canadian Society of Allergy and Clinical Immunology Annual Scientific Meeting 2010

Open Access

Efficacy and safety of medium and high doses of mometasone furoate/formoterol (MF/F) combination treatment in subjects with severe persistent asthma

  • Steven F Weinstein1Email author,
  • Kevin R Murphy2,
  • Jonathan Corren3,
  • Hendrik Nolte4 and
  • Martha V White5
Contributed equally
Allergy, Asthma & Clinical Immunology20106(Suppl 2):P34

DOI: 10.1186/1710-1492-6-S2-P34

Published: 22 December 2010

Background

Multiple strengths of mometasone furoate/formoterol (MF/F) MDI combination therapy are under investigation as new treatments for asthma. We report efficacy/safety findings from a 3-month MF/F study in subjects with severe asthma.

Materials and methods

This was a 3-month, randomized, double-blind, parallel-group, multicenter study with a 2-3-week open-label, run-in period of mometasone furoate (MF) 400 μg twice-daily (BID). Subjects (≥12 years) were randomized to MF/F (200/10 μg or 400/10 μg BID) or MF (400 μg BID). The primary endpoint was the area under the curve (AUC) of the change in serial FEV1 (0-12 hours) for MF/F 400/10 μg vs MF 400 μg from baseline to Week 12. Adverse events (AEs) and other clinical safety measures were recorded.

Results

A total of 728 subjects (mean: age = 47.9 y, asthma duration = 14.0 y, FEV1 % predicted = 66.3, reversibility = 22.9%, Asthma Control Questionnaire [ACQ] score = 1.93) were randomized. Improvements in mean changes from baseline in FEV1 AUC0-12 h (L × h) at Week 12 were MF/F 200/10 μg = 3.59, MF/F 400/10 μg = 4.19, and MF 400 μg = 2.04, with both MF/F doses significantly better than MF (p < 0.001). These FEV1s correspond to average hourly increases of 0.30, 0.35, and 0.17 L, respectively. MF/F was associated with rapid (< 5 min) and sustained improvement in lung function. The percentage of subjects experiencing asthma deterioration (ie, severe asthma exacerbation) was 12.4% (MF/F 200/10 μg), 12.2% (MF/F 400/10 μg), and 18.3% (MF 400 μg). There were no notable differences in AEs between the groups.

Conclusions

Both medium- and high-dose MF/F combination therapy led to significantly greater improvements in lung function compared with high-dose MF monotherapy in severe asthmatics.

Notes

Authors’ Affiliations

(1)
llergy and Asthma Specialists Medical Group and Research Center
(2)
Boys Town National Research Hospital
(3)
Allergy Medical Clinic, Research Division
(4)
Merck Research Laboratories
(5)
Institute for Asthma and Allergy

Copyright

© Weinstein et al; licensee BioMed Central Ltd. 2010

This article is published under license to BioMed Central Ltd.

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