Mometasone furoate nasal spray provides early, continuing relief of nasal congestion and improves nasal patency in allergic patients.
BACKGROUND
Patients report nasal congestion as the most bothersome seasonal allergic rhinitis (SAR) symptom. Measurement of this symptom in previous research has largely been based on subjective patient ratings. This study was designed to measure efficacy, onset, and duration of action of the corticosteroid mometasone furoate nasal spray (MFNS) on nasal congestion using an environmental exposure chamber (EEC) and the objective assessment acoustic rhinometry (AcR).


METHODS
In a randomized, double-blind, placebo-controlled study, ragweed-sensitive subjects were exposed to ragweed pollen (3500 ± 500 pollen grains/m(3)) in an EEC (day 1). Subjects rated instantaneous total nasal symptom score (TNSS), including NSS for congestion (NSS-C). Qualifying subjects received MFNS, 200 micrograms, or placebo and rated postdosing symptoms; a subset received MFNS, 200 micrograms, or placebo q.d. for 6 subsequent days, returning to EEC on day 8. Days 1 and 8 assessments included AcR, TNSS, and the Rhinoconjunctivitis Quality of Life Questionnaire developed for use in the EEC (RQOLQ-EEC).


RESULTS
At day 1, hour 6, patients receiving MFNS (n = 155) reported significantly reduced congestion versus placebo (n = 155) per AcR and NSS-C after one dose, showing numerically superior TNSS change from baseline (p = NS). Among the subset who received 6 additional days of treatment, MFNS (n = 78) yielded significantly lower TNSS versus placebo (n = 77) before day 8 EEC entry and throughout 4-hour exposure (p < 0.05), except at 3.5 hours. AcR showed lower congestion with MFNS versus placebo before day 8 EEC exposure and at 24 and 26 hours after final dose (p < 0.05 for all). AcR and NSS-C correlated at multiple time points. Day 8 RQOLQ-EEC between-group scores were significantly different (p = 0.02) for practical problems.


CONCLUSIONS
MFNS, 200 micrograms, showed onset of nasal congestion relief at 6 hours and duration of action beyond 24 hours postdosing. Objective and subjective assessments were correlated in subjects with maximal (placebo) or minimal (MFNS treatment) congestion symptoms; both assessments were correlated with improved QOL.
Cetero Research, 4520 Dixie Road, Mississauga, Ontario, Canada. annemarie.salapatek@cetero.com
Anne Marie
AM
Salapatek
Piyush
P
Patel
Gokul
G
Gopalan
Santosh T
ST
Varghese
D000328:Adult; D000368:Aged; D031164:Ambrosia / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate; D015508:Nasal Obstruction / Q000188:drug therapy* / Q000523:psychology; D059085:Nasal Sprays; D011244:Pregnadienediols / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D023842:Rhinometry, Acoustic
D059085:Nasal Sprays; D011244:Pregnadienediols; D000068656:Mometasone Furoate