title: Mizolastine provides effective symptom relief in patients suffering from perennial allergic rhinitis: a double-blind, placebo-controlled study versus loratadine.
abstract: 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.
authors.affiliation: Hôpital Américain, Neuilly sur Seine, France.
authors.forename: Charles
authors.initials: C
authors.lastname: Frèche
authors.forename: Francisque
authors.initials: F
authors.lastname: Leynadier
authors.forename: Friedrich
authors.initials: F
authors.lastname: Horak
authors.forename: David
authors.initials: D
authors.lastname: Hide
authors.forename: Fernando Duce
authors.initials: FD
authors.lastname: Gracia
authors.forename: Manfred
authors.initials: M
authors.lastname: Goos
authors.forename: Claus
authors.initials: C
authors.lastname: Bachert
authors.forename: Attila
authors.initials: A
authors.lastname: Horvath
authors.forename: Eva
authors.initials: E
authors.lastname: Antosova
authors.forename: Muriel
authors.initials: M
authors.lastname: Verrecchia
authors.forename: Paul Ben
authors.initials: PB
authors.lastname: Soussen
mesh_terms: 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
chemical_list: D018926:Anti-Allergic Agents; D001562:Benzimidazoles; D006634:Histamine H1 Antagonists; C076170:mizolastine; D017336:Loratadine