Rationale RPNS, a recently developed nasal glucocorticosteroid for AR, was compared to BANS with known efficacy for AR, and placebo, using the EEU, a controlled-pollen exposure setting. Methods This double-blind, randomized, placebo-controlled, parallel-group study of 291 adults ≥16 years of age with seasonal (ragweed) AR evaluated 3 doses of RPNS (20, 100, 200 μg) with BANS (128 μg) and placebo once daily for 8 days (3 pretreatment days followed by 5 days consisting of 3 hour EEU challenge sessions). Primary efficacy variables were changes in morning and evening total nasal symptom score (TNSS) and peak nasal inspiratory flow (PNIF). Results Only the 200-μg dose of RPNS significantly reduced morning TNSS compared with placebo (P=.007); no RPNS treatment group demonstrated significant differences in evening TNSS compared with placebo. However, BANS treatment significantly reduced morning TNSS compared with placebo (P Conclusion Rofleponide palmitate nasal spray was less effective than budesonide aqueous nasal spray 128 μg for the relief of symptoms of seasonal AR when compared with placebo and at doses up to 100 μg upon comparing both active medications. Both active medications were well tolerated.

Background: The environmental exposure unit (EEU) is an instrument designed to determine onset of action of antiallergic treatment. Confirmation of test results would be useful in defining its role.Objective: This study was intended to confirm a previous study comparing cetirizine, loratadine, and placebo in the EEU using an identical protocol design (randomized, double-blind, parallel-group comparison having the same symptom scoring system, endpoints, and statistical analyses), thus demonstrating reproducibility of studies conducted in the EEU.Methods: Onset of action and symptom relief with once-daily cetirizine 10 mg, loratadine 10 mg, and placebo (n = 120 each group) were evaluated replicating a previous study design. Subjects meeting inclusion and exclusion criteria and qualifying symptom scores were randomized to 2 days' exposure (6 to 7 hours daily) with treatment. Changes in total and major symptom complex (TSC, MSC) scores based on 14 symptoms evaluated at 30-minute intervals served as primary efficacy variables.Results: Onset of action again was earlier with cetirizine (at 1 hour, P less than or equal to 0.001) versus loratadine (at 3 hours, P less than or equal to 0.01). Cetirizine produced a 25.4% least-square mean reduction in TSC scores overall versus an 11.2% decrease with loratadine (P = 0.006) and a 4.8% increase with placebo (P < 0.001); loratadine and placebo were also significantly different (P = 0.002). Similar changes were also noted in MSC scores. Cetirizine consistently reduced TSC and MSC scores after the first dose versus placebo (P 5 0.001) and at most time points versus loratadine (P less than or equal to 0.05). Adverse events were reported in 1.7% of patients in each active-treatment group and in 2.5% on placebo.Conclusions: Cetirizine acted earlier and was more effective than loratadine or placebo in reducing symptoms of seasonal allergic rhinitis in subjects undergoing a controlled pollen challenge, replicating results from an earlier, identically designed study, demonstrating reproducibility of these assessments by the EEU.

This study evaluated the safety of fexofenadine in patients

Background: Allergic rhinitis affects nearly one in 10 Ammericans. Cetirizine is a newerer once-daily selective H-1-antagonist. In traditional clinical trials, cetirizine has been shown to be safe and effective for the treatment of seasonal and perennial allergic rhinitis and chronic idiopatic urticaria. Objective: To better characterize the efficacy and onset of action of cetirizine in a more controlled but clinically relevant setting, this agent was compared with loratadine and placebo in patients with symptomatic seasonal allergic rhinitis undergoing controlled pollen chalenge in an environmental exposure unit (EEU). Methods: This was a double-blind, randomized, parallel-group study. After screening, patients were exposed to ragweed pollen (primed) in the EEU (up to six exposures), and those with qualifying symptom scores were randomized to controlled pollen exposure (two periods of 5.5 to 6.5 hours over 2 days) and once-daily treatment with 10 mg cetirizine (n = 67), 10 mg loratadine (n = 67), or placebo (n = 68). the mean ragweed pollen level was 3,480 +/- 350 grains/m(3) (standard deviation), the primary efficacy variables were the total symptom complex (TSC) and the major symptom complex (MSC) scores. Symptoms were evaluated every half hour in the EEU throughout the study. Results: Cetirizine produced a 36.7% mean reduction in TSC scores overall versus 15.4% with loratadine and 12.0% with placebo (p less than or equal to 0.01). Cetirizine also produced a 37.4% mean reduction in MSC scores overall versus 14.7% with loratadine and 6.7% with placebo (p less than or equal to 0.01). Onset of action as assessed by reductions in TSC and RISC scores versus placebo was evident within 1 hour with cetirizine (p less than or equal to 0.02) and 3 hours with loratadine (p less than or equal to 0.03). The incidence of treatment-related side effects was similar among groups, with headache reported most commonly in each group. Conclusions: Cetirizine is well tolerated and effective in reducing symptoms of seasonal allergic rhinitis in patients undergoing controlled pollen challenge.

Cetirizine, terfenadine, astemizole and loratadine are commonly used for the treatment of allergic rhinitis in Canada. All four medications have proven to be efficacious in standard clinical trials, but there has been no conclusive clinical evaluation of their relative times to onset of action.

Background: Many nasal corticosteroids with different potencies and formulations are available, but they have all been proven safe and effective. The clinical relevance, if any, of these differences is not gel completely established.Objective: We sought to compare the efficacy, safety, and patients' acceptance of triamcinolone acetonide aerosol spray and fluticasone propionate aqueous solution in the treatment of spring allergic rhinitis.Methods: After a drug-free baseline evaluation, patients with rhinitis were randomized to receive either a triamcinolone aerosol spray of 110 mu g in each nostril once daily (n = 117) or a fluticasone solution spray of 100 mu g in each nostril once daily (n = 116) in a single-blind, parallel-group study. The Rhinitis Index Score (sum of scores of symptoms on a scale from 0 to 3) was evaluated daily, in the morning before drug administration, for 21 days. The efficacy of each treatment was assessed by the mean reduction from baseline in the Rhinitis Index Score and in individual symptom scores. Patients' acceptance of the study drugs was also monitored by a daily questionnaire.Results: Reductions of the Rhinitis Index Score (mean +/- SEM) were 4.20 +/- 0.21 and 4.60 +/- 0.21 for triamcinolone and fluticasone, respectively (p = 0.23). There were no statistically significant differences between the drugs in the reduction of any of the individual symptoms. Patients expressed statistically significant differences between the drugs regarding acceptance; different properties of the aerosol and the solution were appreciated differently.Conclusions: This study shows that triamcinolone acetonide aerosol and fluticasone propionate solution sprays are both clinically equally effective, safe, and well tolerated for the treatment of spring pollen allergic rhinitis.