Rb. Berkowitz et al., Mometasone furoate nasal spray is rapidly effective in the treatment of seasonal allergic rhinitis in an outdoor (park), acute exposure setting, ALL ASTH P, 20(3), 1999, pp. 167-172
The objective of this study was to determine the time to onset of symptom r
elief following a single dose of mometasone furoate nasal spray (MFNS) in s
ymptomatic patients with seasonal allergic rhinitis (SAR). This was a singl
e-center, placebo-controlled, double-blind, randomized parallel-group study
with a 7-day run-in period followed by a single-close administration of me
dication or placebo in an outdoor park setting. The park site provided an a
cute exposure to seasonal (tl-ee and grass) pollens. Patients remained in t
he park for approximately 12 hours after dosing, during which time hourly a
ssessments of SAR symptoms were recorded on a diary card Two hundred thirty
-nine patients with symptoms of SAR entered the study. Patients receiving a
ny concurrent medication for treatment of their symptoms were excluded. Pat
ients were randomized in a 1:I ratio to receive treatment with either a sin
gle dose of MFNS (200 mu g) or matching placebo nasal spray. Outcome measur
es included an assessment of overall therapeutic response and change from b
aseline in total nasal plus non-nasal sign/symptom severity score, total na
sal sign/symptom severity score, and total non-nasal sign/symptom severity
score. Improvement in total nasal symptom scares, total nan-nasal symptom s
cores, and total nasal plus non-nasal symptom scores were greater- a,td mor
e sustained in patients receiving MFNS than in patients receiving placebo.
The mean decrease from baseline in total nasal plus non-nasal symptom score
s was significantly greater in MFNS-dosed patients than in placebo-dosed pa
tients at 5 hours after dosing (p < 0.01). The mean decrease from baseline
in total nasal symptom scores was significantly greater in MFNS-dosed patie
nts than in placebo-closed patients at 7 hours after dosing (p < 0.01). The
between-treatment differences in total nasal plus non-nasal symptom scores
and total nasal symptom scores remained significant for all subsequent hou
rly assessments through 12 hours post-dose. Patient assessments of overall
response to therapy at endpoint were significantly different between treatm
ent groups (p < 0.01) with 60.5% of MFNS-treated patients reporting complet
e, marked, or moderate relief compared with 46.5% of placebo-treated patien
ts. Mometasone furoate nasal spray produces a statistically significant imp
rovement in in nasal symptom scores in patients with SAR by 7 hours after a
dministration of a single 200 mu g dose (100 mu g in each nostril).