Olopatadine hydrochloride in children: efficacy and safety for perennial allergic rhinitis

Abstract

Objective:

The efficacy of antihistamines in perennial allergic rhinitis in children has been evaluated in studies using active comparators, whereas placebo-controlled studies are very few. A randomized, multicenter, double-blind, parallel-group clinical study was carried out to evaluate the dose–response relationship and superiority of olopatadine hydrochloride over placebo in children aged 7 to 16 years with perennial allergic rhinitis.

Methods:

Subjects received twice daily treatment for two weeks with either olopatadine 2.5 mg, 5 mg or placebo after a one-week observation period. Efficacy was assessed based on the diary card score the subject (or guardian) recorded.

Results:

Of the 302 subjects randomized, two were excluded from analysis: one did not receive treatment; the other was not monitored for efficacy parameters. The remaining 300 subjects (97 in the placebo group, 103 in the olopatadine 2.5-mg group and 100 in the olopatadine 5-mg group) constituted the full analysis set (FAS) for the efficacy analysis. As a primary endpoint, the total three nasal symptom score (for sneezing, rhinorrhea and nasal congestion) at final assessment was compared with baseline or the score obtained in the observation period. The change from baseline was then tested using analysis of covariance (ANCOVA) with the baseline score as covariate. Williams’ test was applied to the least squares means estimated from this ANCOVA model for each treatment group, resulting in showing the monotonicity Williams’ test assumed. The total three nasal symptom score significantly improved in the 5-mg group compared with the placebo group (p = 0.019). In contrast, the 2.5-mg group did not differ statistically from the placebo group. Adverse events occurred in 33.7% (33/98 subjects) in the placebo group, 35.9% (37/103 subjects) in the 2.5-mg group and 35.0% (35/100 subjects) in the 5-mg group. There were no serious or severe adverse events.

Conclusions:

Olopatadine hydrochloride 5 mg twice daily is an effective and safe treatment for perennial allergic rhinitis in children.

Key words::

• Antihistamine
• Children
• Double-blind study
• Olopatadine
• Perennial allergic rhinitis
• Placebo

Transparency

Declaration of funding

This study was funded by Kyowa Hakko Kirin Co., Ltd.

Declaration of financial/other relationships

K.O. has disclosed that he acted as a consultant and medical advisor for this study. M.O. has disclosed that he acted as a consultant for this study. H.M. and K.K. have disclosed that they are employees of Kyowa Hakko Kirin Co., Ltd.

Some peer reviewers receive honoraria from CMRO for their review work. The peer reviewers of this paper have disclosed that they have no relevant financial relationships.

Acknowledgment

Data presented in this article corresponds with the Kyowa Hakko Kirin study identifier 4679-0421. The authors thank the following clinics for their participation: Hiroyuki Sano, Hidehiro Nakadate, Kazuo Ishikawa, Mizuho Goto, Hokkaido; Fumio Sakaguchi, Harumi Seki, Sadamu Minami, Hideaki Koyama, Keisuke Uesugi, Shunsuke Takamatsu, Tokyo; Takao Shizuka, Seiji Sawaki, Tomohide Hoshikawa, Hiromi Wada, Takuma Yoshikawa, Naoki Katsumi, Kanagawa; Hiroyuki Tada, Yasuko Murakawa, Chiba; Emiko Shiba, Saitama; Toshio Otsubo, Tomoko Torii, Toshiya Fujimori, Atsushi Usami, Masahiko Adachi, Shizuoka; Hirofumi Morita, Tadashi Shiraki, Aichi; Akiko Tamaki, Haruhiko Masutani, Hiroshi Kikumori, Kenji Baba, Kenichi Shimada, Osaka”. The authors also thank the Kyowa Hakko Kirin 4679-0421 study team for their contribution to this study.