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

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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.

Author information

Correspondence to Robert A Nathan.

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Open Access This article is published under license to BioMed Central Ltd. This is an Open Access article is distributed under the terms of the Creative Commons Attribution 2.0 International License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Keywords

  • Asthma
  • Asthma Exacerbation
  • Persistent Asthmatic
  • Mometasone
  • Improve Lung Function