Comparative safety and efficacy of two formulations of mometasone nasal spray in adult seasonal allergic rhinitis
Mometasone furoate as a nasal spray is an effective treatment for seasonal allergic rhinitis (SAR). An aqueous mometasone nasal spray containing the same active substance and excipients as the originator product (reference mometasone) has been developed. This study was designed to establish
therapeutic equivalence of test mometasone to reference mometasone and superiority over placebo for the treatment of SAR in adults. In this multicenter, randomized, double-blind, placebo- and active-controlled, fixed-dose study, patients aged ≥18 years with SAR were randomized 2:2:1 to
reference mometasone, test mometasone, or placebo for 28 days. Patients recorded nasal and ocular symptoms daily. The primary end point was change from baseline in the pooled 24-hour reflective total nasal symptom score (rTNSS). Safety and tolerability included evaluation by adverse events
(AEs), physical (including nasal) examinations, vital signs assessments, laboratory evaluations, and change in concomitant medications. Four hundred two patients received reference mometasone (n = 156), test mometasone (n = 163), or placebo (n = 83). The intent-to-treat population (ITT) comprised
399 patients, and the per-protocol (PP) population comprised 327 patients. The 95% confidence intervals for the treatment difference (reference minus test mometasone) in change from baseline in pooled 24-hour rTNSS were within prespecified equivalence limits for the PP and ITT populations.
Both active treatments showed superiority over placebo (p = 0.0019‐0.0087). No significant difference was seen between test mometasone and reference mometasone for any secondary efficacy variables. Treatment-emergent AE incidence was low. No deaths or serious AEs were reported. The
test mometasone is efficacious in the treatment of SAR in adults and shows a favorable safety profile. The results indicate that the test mometasone is therapeutically equivalent to the reference mometasone.
Keywords: Adult; Nasonex; SAR; Sandoz mometasone; mometasone furoate; nasal spray; seasonal allergic rhinitis; therapeutic equivalence; total nasal symptom score
Document Type: Research Article
Publication date: 01 July 2014
This article was made available online on 27 May 2014 as a Fast Track article with title: "Comparative safety and efficacy of two formulations of mometasone nasal spray in adult seasonal allergic rhinitis".
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