A Multicenter Randomized Double-Blind 2-Week Comparison Study of Azelastine Nasal Spray 0.1% versus Levocabastine Nasal Spray 0.05% in Patients with Moderate-to-Severe Allergic Rhinitis

Abstract

Objective: To compare the onset of action, efficacy, and safety of azelastine and levocabastine in the treatment of allergic rhinitis. Subjects and Methods: In a multicenter, randomized, double-blind, parallel-group trial, 244 patients with moderate-to-severe allergic rhinitis were randomized to receive either azelastine hydrochloride nasal spray (ANS) 0.1% or levocabastine hydrochloride nasal spray (LNS) 0.05% for 14 consecutive days. A visual analog scale was used to record total nasal symptom score (TNSS) changes. Indexes for further assessment included onset of action, total effective rate, and evaluation of therapeutic effect. Results: Statistically significant changes from baseline in TNSS were seen in both the LNS group and the ANS group. No significant differences were seen between the two groups in terms of evaluation of therapeutic effect, total effective rate, and onset of action, except for a higher symptom relief rate in the LNS group than in the ANS group within 30 min of administering the first dose. Adverse reactions were mild to moderate, with an incidence of 0.9% for LNS and 2.5% for ANS. Conclusion: Both ANS and LNS were effective and safe in the treatment of moderate-to-severe persistent allergic rhinitis. Moreover, LNS reached a higher symptom relief rate within 30 min of administering the first dose.

Chinese Society of Allergy Guidelines for Diagnosis and Treatment of Allergic Rhinitis

“…Currently, only 4 intranasal antihistamine products (AZEP, MIN QI, LIVOSTIN and SHUNTUOMIN) are available for the treatment of AR patients in China, of which AZEP (azelastine hydrochloride) has the largest share of the Chinese market ( Table 8 ). In a multicenter, randomized, double-blind, parallel-group trial, Han and colleagues 352 have demonstrated that azelastine and levocabastine nasal sprays, which are commonly used worldwide for the treatment of AR, are comparably safe and effective in the treatment of Chinese patients with moderate-to-severe persistent AR.…”

International consensus statement on allergy and rhinology: Allergic rhinitis – 2023

“…This included 24 studies with an active treatment comparator arm 1479,1805–1827 and 29 studies with an inactive placebo arm 1808,1809,1812–1814,1816,1818,1820,1822,1824,1825,1828–1845 . Monotherapy with azelastine was reported in 37 studies 1479,1805,1806,1808,1810–1816,1818–1828,1831–1836,1840–1848 while monotherapy with olopatadine was reported in 10 studies 1807,1809,1829,1830,1833,1835,1837–1839,1847 . Some studies utilized multiple active treatment arms of antihistamine and/or corticosteroid (Table XI.B.1.c).…”

“…Azelastine and olopatadine were directly compared in three studies, with no significant difference in symptom relief between agents 1833,1835,1847 . Azelastine was compared with an experimental formulation of intranasal levocabastine in two additional studies, with either comparable or superior results for azelastine 1846,1848 . Levocabastine is not available as a commercial product.…”