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Once-Daily and Twice-Daily Mometasone Formulations Show Similar Efficacy in Persistent Asthmatics: Presented at ATS.
Treatment with mometasone furoate dry powder (MF-DPI) at dosages of 440 mcg once nightly and 220 mcg twice daily produces similar significant decreases in the need for albuterol rescue medication in patients with persistent asthma who are dependent on inhaled corticosteroids (ICS), researchers announced here at the International Conference of the American Thoracic Society (ATS).
The results of a pooled analysis of 2 randomized, placebo-controlled, 12-week trials of MF-DPI involving a total of 590 patients were reported by Lucy Schneyer, MA, researcher, pharmacology division, Schering-Plough Research Institute, Kenilworth, New Jersey.
Participants were at least 12 years of age with a history of asthma for at least 12 months, and had been previously maintained on ICS therapy.
The 3 treatment groups were as follows: MF-DPI 440 mcg once nightly (n = 250); 220 mcg twice daily (n = 170); and placebo (n = 170). The subjects in these groups were similar with respect to age, sex, race, duration of asthma, percent of predicted forced expiratory volume in 1 second (FEV1), and prior ICS use.
Subjects maintained journals to document their use of albuterol administered via metered-dose inhaler or nebulizer. A secondary endpoint was changes from baseline in the frequency of albuterol use as a rescue medication.
The trial excluded patients who had been treated with immunosuppressive agents for asthma control within the prior 3 months and patients who had used nebulized beta2-agonists or long-acting inhaled beta2-agonists on a daily basis.
The researchers documented a decrease in albuterol rescue in both groups of MF-DPI subjects, but an increase in the placebo group. The change at endpoint was -1.59 (± 0.16) in the MF-DPI 440 mcg once nightly group, -1.68 (± 0.20) in the MF-DPI 220 mcg twice daily group, and 0.45 (± 0.20) in the placebo group.Differences from placebo were significant (P <.0001) with both MF-DPI treatments; the difference in efficacy between the MF-DPI treatments was not significant.
The study also found that MF-DPI was well tolerated, and most adverse events were mild to moderate in severity. The most commonly reported treatment-emergent adverse events were upper respiratory-tract infection and headache.