Allergy Asthma Immunol Res.  2015 Mar;7(2):158-166. 10.4168/aair.2015.7.2.158.

Comparison of Intranasal Ciclesonide, Oral Levocetirizine, and Combination Treatment for Allergic Rhinitis

• Kim CH
• Kim JK
• Kim HJ
• Cho JH
• Kim JS
• Kim YD
• Lee HM
• Kim SW
• Cho KS
• Lee SH
• Rhee CS
• Dhong HJ
• Rha KS
• Yoon JH

• KMID: 2365544
• DOI: http://doi.org/10.4168/aair.2015.7.2.158

Abstract

PURPOSE
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 microg 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.

Keyword

Allergic rhinitis; ciclesonide; levocetirizine

MeSH Terms

Asthma
Estrogens, Conjugated (USP)
Humans
Nose
Pruritus
Rhinitis*
Rhinitis, Allergic, Seasonal
Surveys and Questionnaires
Estrogens, Conjugated (USP)

Figure

• 

  Fig. 1 Study flow and subject disposition. A total of 258 subjects aged ≥18 years successfully completed the study. Subjects were randomly assigned to treatment groups receiving 200 µg ciclesonide nasal spray, 5 mg oral levocetirizine, or a combination of both.

• 

  Fig. 2 Changes in efficacy parameters. Analysis of symptom severity was conducted using reflective total nasal symptom score (rTNSS) values recorded in patient diaries and averaged over the 2-week period. The rTNSS was calculated as the sum of four nasal symptoms: rhinorrhea, nasal itching, nasal congestion, and sneezing, each of which was rated on a scale of 0 (no signs/symptoms evident) to 3 (signs/symptoms causing significant discomfort that interfered with daily activities) for the full analysis set (FAS) population. The Reflective total ocular symptom score (rTOSS) was calculated as the sum of three ocular symptoms: itchy eyes, red eyes, and watery eyes, each rated on a scale of 0 (no signs/symptoms evident) to 3 (signs/symptoms causing significant discomfort that interfered with daily activities). physician-assessed overall nasal signs and symptoms severity (PANS) values were obtained from the investigators assessments of nasal signs (discoloration, swelling, discharge, and postnasal drip) and symptoms (rhinorrhea, itching, nasal congestion, and sneezing). Rhinoconjunctivitis quality-of-life questionnaires (RQLQ) was obtained via patient self-assessment of the 28 listed items. SD, standard deviation.

• 

  Fig. 3 Changes in efficacy parameters. Analysis of symptom severity was conducted using rTNSS (reflective total nasal symptom score) values recorded in patient diaries and averaged over the 2-week period. The rTNSS was calculated as the sum of four nasal symptoms: rhinorrhea, nasal itching, nasal congestion, and sneezing, each of which was rated on a scale of 0 (no signs/symptoms evident) to 3 (signs/symptoms causing significant discomfort that interfered with daily activities) for the full analysis set (FAS) population. The P values shown in the figure measure statistical significance between C (ciclesonide) vs L (levocitirizine) vs C+L (combination treatment) groups at P<0.05 through ANOVA. The P value for rhinorrhea was 0.0388, for itching 0.0429, for nasal congestion 0.0202, and for sneezing 0.4014. If a P value indicated statistical significance at P<0.05 within a scoring system, additional comparative analyses were performed in order to clarify which groups were responsible for the significance. Significant comparisons at the 0.05 level are indicated by asterisks (*) through multiple comparison analysis by Fisher's Least Significance Difference (LSD). Whiskers to the bars indicate SEM.

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  Fig. 4 Correlation analysis between rTNSS and PANS. Exploratory analysis for the correlation of rTNSS and PANS was conducted using Pearson's correlation analysis.

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