WASHINGTON — A 100-mcg dose of the inhaled corticosteroid mometasone furoate, given either once or twice daily, significantly reduced the need for rescue medications in 296 children aged 4–11 years with mild to moderate persistent asthma.
Overall, children in both the once- and twice-daily mometasone furoate (MF) groups averaged significantly fewer puffs of rescue medication after 12 weeks, compared with a placebo group. The average baseline rescue medication use was 1.3 puffs per day in all three groups. Children in the once-daily and twice-daily treatment groups reported average reductions in rescue medication use of 19.5% and 13.4%, respectively. By contrast, rescue medication use increased by an average of 22% in the placebo group during the study period.
“Rescue medication use was reduced quickly and showed a trend for progressive reduction over the entire 12-week treatment period,” Dr. William E. Berger, who is in private practice in Mission Viejo, Calif., and his colleagues, reported in a poster presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
MF recently was approved to treat asthma in children aged 4–11 years. The current study was part of a larger trial that contributed to the drug's approval, Dr. Berger said in an interview.
The children were randomized to receive a 100-mcg dose of MF (via a dry powder inhaler) once daily (98 children) or twice daily (99 children), or a placebo (99 children). The researchers calculated changes in the number of rescue medication puffs per day and measured peak morning and evening expiratory flow.
The average age of the children was 9 years in the treatment groups and 8 years in the placebo group. The demographics and baseline uses of rescue medication and peak flow measurements were not significantly different among the three groups.
Significant improvements in peak expiratory flow were observed in both treatment groups compared with placebo during each week of the study.
Both doses of MF were well tolerated; the incidence of adverse events was similar in the once-daily, twice-daily, and placebo groups (55%, 60%, and 52%, respectively).
Adverse events included headache and upper respiratory tract infection.
The study population included children aged 4–11 years who had been diagnosed with asthma for at least 6 months. Children who used nebulizers or other long-acting beta2-agonists, had been hospitalized during the 3 months before the study, or who used systemic corticosteroids for at least 15 days during the 6 months before the study were excluded.
These findings parallel the results from the larger drug approval study, which showed that inhaled MF given either once or twice daily was significantly more effective than was placebo at improving pulmonary function in children with mild to moderate asthma, the researchers wrote.
The study was sponsored by Schering-Plough Corp.