Comparison of intranasal ciclesonide, oral levocetirizine, and combination treatment for allergic rhinitis.
OBJECTIVE
To evaluate the efficacy and safety of once-daily ciclesonide in comparison to both levocetirizine alone, and a ciclesonide/levocetirizine combination in patients with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR).


METHODS
Subjects exhibiting moderate to severe allergic rhinitis for longer than 1 year were randomized in an open-label, 3-arm, parallel group, multicenter study. Subjects received 200 µg ciclesonide, 5 mg levocetirizine, or a combination of both. Changes from baseline until the end-of-study visit (2 weeks following) were evaluated by reflective total nasal symptom scores (rTNSSs), reflective total ocular symptom scores (rTOSSs), physician-assessed overall nasal signs and symptoms severity (PANS), and rhinoconjunctivitis quality-of-life questionnaires (RQLQ).


RESULTS
Significant improvements in rTNSS, PANS, and RQLQ in the ciclesonide monotherapy group were observed in comparison to the levocetirizine alone group. Three individual symptoms of rTNSS, including runny nose, nasal itching, and congestion, were improved in the ciclesonide-treated group. rTOSS scores for ciclesonide monotherapy improved from baseline, but no superiority over levocetirizine was shown. The absolute score and changes in rTNSS and PANS were positively correlated. Ciclesonide spray was more effective than levocetirizine in reducing nasal symptoms in both SAR and PAR patients. Ciclesonide and levocetrizine were well tolerated alone and in combination.


CONCLUSIONS
Our results provide support for an AR and its Impact on Asthma (ARIA) recommendation stipulating that ciclesonide is superior to levocetirizine for the treatment of AR, with tolerable safety. Addition of levocetirizine to ciclesonide did not give further clinical benefit over monotherapy.
Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Korea.
Chang-Hoon
CH
Kim
Department of Otorhinolaryngology-Head and Neck Surgery, College of Medicine, Konkuk University, Seoul, Korea.
Jin Kook
JK
Kim
Department of Otolaryngology, Ajou University School of Medicine, Suwon, Korea.
Hyun Jun
HJ
Kim
Department of Otorhinolaryngology-Head and Neck Surgery, The Catholic University of Korea, Seoul, Korea.
Jin Hee
JH
Cho
Department of Otorhinolaryngology-Head and Neck Surgery, College of Medicine, Kyungpook National University, Daegu, Korea.
Jung-Soo
JS
Kim
Department of Otorhinolaryngology-Head and Neck Surgery, College of Medicine, Yeungnam University, Daegu, Korea.
Yong-Dae
YD
Kim
Department of Otorhinolaryngology-Head and Neck Surgery, Korea University College of Medicine, Seoul, Korea.
Heung-Man
HM
Lee
Department of Otorhinolaryngology-Head and Neck Surgery, School of Medicine, Kyunghee University, Seoul, Korea.
Sung Wan
SW
Kim
Department of Otorhinolaryngology, Pusan National University School of Medicine, Busan, Korea.
Kyu-Sup
KS
Cho
Department of Otorhinolaryngology-Head and Neck Surgery, Korea University College of Medicine, Seoul, Korea.
Sang Hag
SH
Lee
Department of Otorhinolaryngology, Seoul National University College of Medicine, Seoul, Korea.
Chae-Seo
CS
Rhee
Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Seoul, Korea.
Hun-Jong
HJ
Dhong
Department of Otolaryngology, Chungnam National University School of Medicine, Daejeon, Korea.
Ki-Sang
KS
Rha
Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Korea.
Joo-Heon
JH
Yoon
Allergic rhinitis; ciclesonide; levocetirizine