Volume 6 Supplement 2

Canadian Society of Allergy and Clinical Immunology Annual Scientific Meeting 2010

Open Access

Efficacy and safety of combined medium-dose mometasone furoate/formoterol (MF/F) in persistent asthmatics

  • Robert A Nathan1Email author,
  • David S Pearlman2,
  • Hendrik Nolte3 and
  • Anjuli Nayak4
Allergy, Asthma & Clinical Immunology20106(Suppl 2):P16

https://doi.org/10.1186/1710-1492-6-S2-P16

Published: 4 November 2010

Background

The availability of controller therapies at multiple strengths is important to treat different severities of asthma (NHLBI and GINA guidelines). The clinical effect of medium-dose mometasone furoate/formoterol (MF/F) combination administered via single inhaler had never been characterized in asthmatic subjects versus placebo. We investigated the effect of medium-dose MF/F administered via an MDI on asthma deteriorations (ie, severe asthma exacerbations) and pulmonary function in moderately-severe asthmatics inadequately-controlled on medium-dose inhaled corticosteroids (ICS) ± long-acting β2-agonists (LABA).

Materials and methods

After 2-3-weeks open-label run-in with MF 200μg BID, subjects (≥12 years) were randomized to 26-weeks treatment BID with MF/F 200/10μg, MF 200μg, F 10μg, or placebo. Coprimary endpoints were time-to-first asthma deterioration over the treatment period (MF/F vs F), and the area under the curve (AUC) of the change in serial FEV1 [0-12 hr] to Week 12 (MF/F vs MF).

Results

781 subjects (mean: age=42.4 y, asthma duration=16.07 y, FEV1 % predicted=72.62%, reversibility=18.80%, ACQ score=1.51) were randomized. MF/F increased the time-to-first asthma deterioration and decreased the proportion of subjects who experienced asthma deteriorations (MF/F=30.4%; MF=33.9% [p=0.565]; F=54.0% [p<0.001]; placebo=55.6% [p<0.001]). MF/F treatment improved lung function more than MF within 5 minutes following administration (p<0.001); mean Week-12 FEV1AUC0-12h (L x h over baseline): MF/F=3.11, MF=1.30, F=1.93, and placebo=0.57 (effect was maintained throughout the treatment period). Adverse events were rare and similar across treatment groups.

Conclusions

MF/F 200/10μg was more effective in reducing asthma deteriorations and improving lung function in asthmatics uncontrolled on medium-dose ICS±LABA than placebo, MF or F.

Authors’ Affiliations

(1)
Asthma and Allergy Associates, P.C
(2)
Colorado Allergy and Asthma Centers, P.C
(3)
Merck Research Laboratories
(4)
Sneeze, Wheeze, and Itch Associates

Copyright

© Nathan et al; licensee BioMed Central Ltd. 2010

This article is published under license to BioMed Central Ltd.

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