Mizolastine provides effective symptom relief in patients suffering from perennial allergic rhinitis: a double-blind, placebo-controlled study versus loratadine.
BACKGROUND
Mizolastine is a nonsedating H1 histamine receptor antagonist with additional antiallergic properties currently marketed in Europe for the treatment of seasonal and perennial allergic rhinitis (PAR) and urticaria.


OBJECTIVE
This multicenter, randomized, double-blind, parallel-group study was conducted to evaluate the efficacy and safety of mizolastine in PAR compared with loratadine and placebo.


METHODS
After a 1-week placebo run-in period, 428 adult PAR patients received placebo (146 of 428), mizolastine 10 mg (141 of 428), or loratadine 10 mg (141 of 428) once daily for 28 days. Symptoms were evaluated by patients and physicians using a total nasal score, evaluating itching, rhinorrhea, nasal blockade, and sneezing severity.


RESULTS
Mizolastine treatment resulted in a significantly greater decrease in patient-rated total nasal score than placebo after 2 weeks (D14; -42%, P < 0.001) and at the end of the treatment period (-46%, P = 0.01), and significantly greater than that observed with loratadine at D14 (P = 0.031). No significant difference in change in total nasal score was observed between loratadine and placebo at 2- and 4-week visits. The global safety was satisfactory and the incidence of adverse events was similar in the three treatment groups.


CONCLUSIONS
Mizolastine provides effective symptom relief in PAR together with a satisfactory safety profile. Improvement with mizolastine was significantly greater than placebo throughout the study despite a large placebo effect. Also mizolastine's effects were greater those observed with loratadine after 2 weeks of treatment.
Frèche
Charles
C
Hôpital Américain, Neuilly sur Seine, France.
Leynadier
Francisque
F
Horak
Friedrich
F
Hide
David
D
Gracia
Fernando Duce
FD
Goos
Manfred
M
Bachert
Claus
C
Horvath
Attila
A
Antosova
Eva
E
Verrecchia
Muriel
M
Soussen
Paul Ben
PB
D000293:Adolescent; D000328:Adult; D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006634:Histamine H1 Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D017336:Loratadine / Q000627:therapeutic use; D008297:Male; D012221:Rhinitis, Allergic, Perennial / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome
D018926:Anti-Allergic Agents; D001562:Benzimidazoles; D006634:Histamine H1 Antagonists; C076170:mizolastine; D017336:Loratadine