Comparative safety and efficacy of two formulations of mometasone nasal spray in adult seasonal allergic rhinitis

Abstract

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.

Epistaxis Risk Associated with Intranasal Corticosteroid Sprays: A Systematic Review and Meta‐analysis

“…22-36 The risk ratio for patients treated with mometasone furoate was 1.48 (95% CI, 1.06-2.07; I 2 = 3%; Figure 6 ). 37-50 Fluticasone propionate was associated with an intermediate risk ratio of 1.36 (95% CI, 1.00-1.85; I 2 = 0%; Figure 7 ). 17,48,51-65…”

Vitamin D3 inhibits micro RNA-17-92 to promote specific immunotherapy in allergic rhinitis

“…Following published procedures 23 with modifications, the medication scores were recorded for each patient during the period of treatment. When necessary, the patients were allowed to take anti-histamine tablets (levocetirizine; 5 mg/tablet) or/and nasal spray of corticosteroid (mometasone).…”

Thixotropy of Nasal Medications—Its Role in Clinical Practice

“…The number of side-effects associated with usage of intranasal glucocorticosteroids was comparable to placebo [15]. In a multicenter, randomized, double-blinded clinical trial Kuna et al indicated the equivalence of two mometasone preparations (original and generic) in effective reducing of nasal and ocular symptoms of allergic rhinitis, with good tolerance and without any serious side-effects [16].…”