Mizolastine provides effective symptom relief in patients suffering from perennial allergic rhinitis: a double-blind, placebo-controlled study versus loratadine

Authors: Frèche, Charles¹; Leynadier, Francisque²; Horak, Friedrich³; Hide, David; Gracia, Fernando D.⁴; Goos, Manfred⁵; Bachert, Claus⁶; Horvath, Attila⁷; Antosova, Eva⁸; Verrecchia, Muriel⁹; Soussen, Paul B.e.n.⁹

Source: Annals of Allergy, Asthma and Immunology, Volume 89, Number 3, September 2002 , pp. 304-310(7)

Publisher: American College of Allergy, Asthma, & Immunology

Key:

- Free Content

- New Content

- Subscribed Content

- Free Trial Content

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.

Document Type: Original article

Affiliations: 1: Hôpital Américain, Neuilly sur Seine, France.* Ear, Nose, and Throat Department, U2 Ghent, Belgium. 2: Hôpital Tenon, Paris, France.† Semmalweiss Medical School, Budapest, Hungary.Deceased 3: Allergiestation der HNO-Universitätsklinik, Vienna, Austria.‡ A. Klinik Imunologie Fakulni Nemocnice, Praha, Czech Republic. 4: Hospital Clinico Universitario, Zaragoza, Spain. 5: Klinik für Dermatologie, Universitätsklinikum, Essen, Germany. 6: Ear, Nose, and Throat Department, U2 Ghent, Belgium. 7: Semmalweiss Medical School, Budapest, Hungary. 8: A. Klinik Imunologie Fakulni Nemocnice, Praha, Czech Republic. 9: Sanofi-Synthelabo, Chilly-Mazarin, France.

The full text electronic article is available for purchase. You will be able to download the full text electronic article after payment.

$28.00 plus tax Refund Policy

Key:

- Free Content

- New Content

- Subscribed Content

- Free Trial Content

Share this item with others: These icons link to social bookmarking sites where readers can share and discover new web pages.