Efficacy and long-term safety of mometasone furoate nasal spray in children with perennial allergic rhinitis.

BACKGROUND

Allergic rhinitis (AR) affects up to 40% of children by age 6 years. Perennial AR (PAR) causes sleep disturbance, diminishes concentration in school, impairs psychosocial functioning, and reduces quality of life. This study evaluated efficacy and long-term safety of the intranasal corticosteroid mometasone furoate nasal spray (MFNS) in children with PAR.

METHODS

This study comprised a double-blind, 4-week efficacy and safety period followed by a 6-month, open-label safety period. Primary efficacy variable during the double-blind period was mean change in physician-evaluated total nasal symptom score (TNSS) from baseline to day 15. Other efficacy variables during this phase included subject-evaluated TNSS, individual nasal symptoms, and total symptom score (TSS, nasal and non-nasal symptoms, summed). Physician-evaluated improvement in overall condition of PAR was assessed during the open-label period. Adverse events (AEs) were monitored throughout.

RESULTS

Subjects aged 3-11 years with PAR (n = 381) were randomized to MFNS 100 microg (n = 190) or placebo (n = 191) daily for 4 weeks; 357 subjects continued into the open-label period, receiving MFNS only. Between baseline and day 15, significantly greater mean changes were seen with MFNS-treated patients than placebo in physician-evaluated TNSS (-2.8, -39%, vs. -2.2, -32%; p = 0.02). Statistically significant improvements in MFNS versus placebo were reported for subject-evaluated TNSS, TSS, and individual nasal symptom scores (p < or = 0.03 for all). Improvement continued through the open-label period. Subjects treated with MFNS in both periods experienced a 45% further reduction in TSS in this study phase, while those who switched from placebo to MFNS saw a further 49% decrease. MFNS was well-tolerated in both periods. The most frequently reported treatment-related AEs during the double-blind period for MFNS and placebo, respectively, were epistaxis, seven (4%) and nine (5%); sneezing, five (3%) and seven (4%); headache, six (3%) and five (3%). During the open-label period, the AEs reported most often were epistaxis 37 (10%), headache nine (3%), and rhinitis 12 (3%).

LIMITATIONS: Studies in children present unique challenges because subjects are too young to grasp subjective concepts such as symptom severity, especially as rated on a numbered scale. In addition, the 6-month extension of the placebo-controlled phase used a single agent. It is also possible that subjects' symptoms could have abated independent of mometasone furoate treatment.

CONCLUSION

MFNS 100 microg/day effectively reduces TNSS, TSS (including ocular symptoms), and individual symptoms associated with PAR and is well-tolerated for up to 6 months in children aged 3-11 years with a safety profile similar to placebo.