Apooled analysis of 1812 patients with seasonal allergic rhinitis (AR) showed that 15 days of therapy with once-daily mometasone furoate nasal spray provided 24-hour symptom relief of nasal congestion/stuffiness, said Mark Dykewicz, MD, of Wake Forest University School of Medicine, Winston- Salem, NC, who presented the results in a poster session.
Although AR is characterized by congestion, rhinorrhea, sneezing, and itching, patients tend to single out congestion as the most bothersome symptom. Almost 50% of patients say that they experience the most severe symptoms in the day; almost 66% want medicine that lasts 24 hours.
Mometasone furoate nasal spray has already demonstrated symptom relief in this patient population. This study focused on the 24-hour nasal symptoms relief through morning awakening.
Data were pooled from 5 randomized, placebo-controlled, parallel-group, multicenter 15-day trials (N = 1812) of mometasone furoate nasal spray 200 μg once daily in patients with symptomatic seasonal AR. Four trials were double-blind phase 3, and 1 was single- blind phase 2. Each of the 5 trials followed a similar protocol, patient characteristics, and comparable nasal congestion and overall total nasal symptom scores (TNSSs).
All patients scored nasal symptom severity once in the morning and 12 hours later. At each evaluation, they rated the previous 12 hours, as well as the present moment (referred to as “NOW”). Changes from baseline in the morning NOW nasal congestion/ stuffiness score and morning NOW TNSS were used as indicators of 24- hour efficacy after dosing.
Impact on Nasal Congestion, Stuffiness
The decrease from baseline in morning NOW nasal congestion/stuffiness score averaged over days 2 through 15 was significantly greater with mometasone furoate nasal spray 200 μg once daily than with placebo (P <.001). On day 2, the decrease in morning NOW nasal congestion/stuffiness score was already significantly greater with mometasone furoate nasal spray 200 μg once daily than with placebo and continued to be greater on each day thereafter (P <.001).
The decrease from baseline in morning NOW TNSS averaged over days 2 through 15 was also significantly greater with the active drug than with placebo nasal spray (P <.001).
Mometasone furoate nasal spray was well tolerated, with similar rates of adverse events in the treatment and placebo spray groups. The investigators concluded that mometasone furoate nasal spray 200 μg administered once daily was superior to placebo in improving the severity of nasal congestion/stuffiness and of TNSS, and was still effective 24 hours after dosing in patients with moderate- to-severe seasonal AR