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BackgroundAzelastine hydrochloride (AZE) is a selective, non-sedating H1 antagonist with anti-inflammatory and mast cell stabilizing properties, which can be used as an alternative to intranasal corticosteroids. The objective of this study was to evaluate the efficacy of the new formulation of 0.15% AZE compared to that of the placebo at a dosage of two sprays per nostril twice daily for 4 weeks in patients with perennial allergic rhinitis (PAR).Materials and methodsA total of 581 subjects were randomized in this double-blind (DB) placebo-controlled trial (NCT00712920) that compared 0.10% (1,096 μg daily) and 0.15% AZE (1,644 μg daily) to the placebo in PAR patients. The study consisted of a 7-day single-blind placebo lead-in period and a 28-day DB treatment period. The primary endpoint was the change from baseline in the 12-h reflective total nasal symptom score (rTNSS) for the entire 28-day study period of 0.15% AZE, two sprays per nostril BID compared to the placebo. The efficacy and safety of 0.15% AZE were compared to the placebo.ResultsLeast square (LS) mean improvement from baseline in the morning (AM) and evening (PM) combined rTNSS was statistically significant for the 0.15% AZE group (p = 0.04) compared to the placebo group. LS mean improvement from baseline in the AM and PM combined rTNSS was 4.10 (4.26) units for 0.15% AZE and 3.81 (3.99) for 0.10% AZE. For individual symptoms, there was a statistically significant change in the LS mean (p = 0.04) improvement from baseline on the 12-h reflective assessment for the 0.15% AZE group for runny nose. Further numerical improvements were shown for itchy nose, nasal congestion, runny nose, and sneezing compared to the placebo. No deaths or serious adverse events related to the study medication were reported.ConclusionThe present formulation of 0.15% AZE is safe and effective in relieving PAR symptoms. It effectively relieves nasal and non-nasal symptoms. Clinical Trial RegistrationClinicalTrials.gov, identifier: NCT00712920.

Two double-blind studies in children aged 6 to 11 years with allergic rhinitis (AR) assessed the efficacy and safety of the intranasal corticosteroid ciclesonide. In the first study, 618 patients with seasonal AR (SAR) were randomized to once-daily ciclesonide 100 μg or 200 μg or placebo for 2 weeks. In the second study, 665 patients with perennial AR (PAR) received once-daily ciclesonide 25 μg, 100 μg, or 200 μg or placebo for 12 weeks. Efficacy evaluations included patient-/caregiver-assessed average morning (am) and evening (pm) 12-hour reflective total nasal symptom scores (TNSS) and physician-assessed nasal symptom scores (PNSS). Safety evaluations included adverse events, nasal examinations, and cortisol levels. Serum concentrations of ciclesonide and its pharmacologically active metabolite, desisobutyryl-ciclesonide, were measured after 6 weeks in patients with PAR. In the SAR study, ciclesonide 200 μg demonstrated significantly greater reductions in TNSS compared with placebo over 2 weeks (treatment difference: 0.39; 95% CI: 0.02, 0.76; p = 0.040). In the PAR study, there was a numerical difference in am and pm reflective TNSS between the ciclesonide 200-μg and placebo groups over 6 weeks. Ciclesonide also improved PNSS in patients with SAR or PAR. Ciclesonide demonstrated a safety profile comparable with placebo. Greater numerical decreases in urine cortisol were observed with ciclesonide compared with placebo; however, differences between treatment groups were not considered clinically relevant. Systemic exposure to ciclesonide was low. These studies demonstrate that ciclesonide ≤200 μg/day reduces nasal symptoms and appears to have a favorable safety profile in children with AR. [ABSTRACT FROM AUTHOR]