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.