Mometasone/formoterol inhalation aerosol: in asthma uncontrolled on medium- or high-dose inhaled corticosteroids.

The corticosteroid mometasone and the long-acting β(2)-selective adrenoreceptor agonist formoterol have been combined in a single pressurized metered-dose inhaler for use in patients aged ≥12 years with asthma. In a 26-week well designed trial in patients with persistent asthma uncontrolled on medium-dose inhaled corticosteroids (ICS), mometasone/formoterol 200 μg/10 μg twice daily (bid) was more effective than placebo or the same nominal dosage of formoterol alone in reducing the incidence of asthma deteriorations, as well as in improving lung function, asthma control, asthma symptoms and asthma-related quality-of-life outcomes. The combination was also more effective than the same nominal dosage of mometasone alone in improving lung function and asthma control. Similarly, in a 12-week well designed trial in patients with persistent asthma uncontrolled on high-dose ICS, mometasone/formoterol 400 μg/10 μg bid was more effective than the same nominal dosage of mometasone alone in improving lung function, asthma control and asthma symptoms. Treatment with a lower dosage of the combination (200 μg/10 μg bid) yielded similar results and, moreover, significantly reduced the incidence of asthma deteriorations compared with mometasone alone. Mometasone/formoterol was generally well tolerated in clinical trials of 12-52 weeks' duration. The adverse event profile of the combination was consistent with that of its individual components; no new or unexpected safety signals were detected.