S103 – Mometasone Is Effective With or Without Oral Antihistamines

Abstract

Objectives

Clinical trials have demonstrated the efficacy of monotherapy with intranasal corticosteroids (INSs) for symptoms of allergic rhinitis (AR). ARIA guidelines suggest adding oral antihistamines to INS monotherapy when severe symptoms do not improve. An open-label multicenter study assessed efficacy and safety of mometasone furoate nasal spray (MFNS) alone or combined with an oral antihistamine in subjects with AR.

Methods

Subjects received MFNS 200 mcg QD for 56 days, with an oral antihistamine added at Day 28 or later if baseline symptoms (sneezing, nasal discharge/obstruction, tiredness, irritability) had not improved. Subjects rated individual symptom scores, daily routine and sleep limitations, and product attributes on Days 1, 28, and 56 on a scale of 0 to 10, and completed a compliance questionnaire on Day 56.

Results

Mean scores for AR symptoms and limitations on sleep and daily routines significantly improved from baseline to Day 28 and from Day 28 to 56 (P less than 0.001 for all). At Days 28 and 56, 47/60 and 45/56 subjects, respectively, were receiving MFNS monotherapy, and 13 required a concomitant oral antihistamine at Day 28 or later. By Day 56, symptom severity improved in 92% of subjects receiving concomitant therapy. At study end, 88% of subjects reported compliance with QD MFNS. Average product attribute scores ranged from 7.2 to 8.4. No severe adverse events were reported.

Conclusions

MFNS 200 mcg QD, alone or combined with an oral antihistamine, was safe and effective against AR nasal symptoms and limitations of sleep and daily activities.