Original Paper

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
Demin Han^a, Lei Chen^b, Lei Cheng^c, Shixi Liu^d, Zheng Fu^e, Wei Zhang^a, Chengshuo Wang^a, Lin Xi^a, Luo Zhang^a, The Chinese Allergic Rhinitis Collaborative Research Group (C²AR²G)

^aDepartment of Otolaryngology, Head and Neck Surgery, Beijing Tong Ren Hospital, Capital Medical University, Beijing Institute of Otolaryngology, and
^bDepartment of Otolaryngology, Head and Neck Surgery, People’s Liberation Army General Hospital, Beijing,
^cDepartment of Otolaryngology, Head and Neck Surgery, First Affiliated Hospital, Nanjing Medical University, Nanjing,
^dDepartment of Otolaryngology, Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, and
^eDepartment of Otolaryngology, Head and Neck Surgery, Hainan Provincial People’s Hospital, Haikou City, China

Address of Corresponding Author

ORL 2011;73:260-265 (DOI: 10.1159/000330269)

  Key Words

• Allergic rhinitis
• Antihistamine
• Azelastine
• Chinese
• Levocabastine

  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.

Copyright © 2011 S. Karger AG, Basel

  Author Contacts

Luo Zhang, MD
Beijing Institute of Otolaryngology
No. 17 Hougouhutong
Dong-Cheng District, Beijing 100005 (China)
Tel. +86 10 6514 1136, E-Mail dr.luozhang@gmail.com

  Article Information

Demin Han, Lei Chen, Lei Cheng, Shixi Liu, Zheng Fu, and Wei Zhang contributed equally to this work.

Received: April 5, 2011
Accepted after revision: June 8, 2011
Published online: August 11, 2011
Number of Print Pages : 6
Number of Figures : 3, Number of Tables : 0, Number of References : 19