Mometasone furoate nasal spray is rapidly effective in the treatment of seasonal allergic rhinitis in an outdoor (park), acute exposure setting

Citation
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
Citations number
13
Categorie Soggetti
Clinical Immunolgy & Infectious Disease
Journal title
ALLERGY AND ASTHMA PROCEEDINGS
ISSN journal
10885412 → ACNP
Volume
20
Issue
3
Year of publication
1999
Pages
167 - 172
Database
ISI
SICI code
1088-5412(199905/06)20:3<167:MFNSIR>2.0.ZU;2-0
Abstract
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).