Onset of action for loratadine tablets for the symptomatic control of seasonal allergic rhinitis in adults challenged with ragweed pollen in the Environmental Exposure Unit: a post hoc analysis of total symptom score

Mark W Tenn, Lisa M Steacy, Charlene C Ng, Anne K Ellis, Mark W Tenn, Lisa M Steacy, Charlene C Ng, Anne K Ellis

Abstract

Background: Loratadine is a second-generation, non-sedating antihistamine used for the relief of allergic rhinitis symptoms. Previous studies reported that when loratadine was encapsulated, the onset of action for symptom relief was 180 min. However, unmodified loratadine tablets were not evaluated at that time. Using data from a previously published Environmental Exposure Unit (EEU) study comparing azelastine nasal spray with loratadine tablets, cetirizine tablets, and placebo, this post hoc analysis determines the onset of action of loratadine tablets (i.e. unmodified) by analyzing the total symptom score for the relief of nasal and ocular seasonal allergic rhinitis (SAR) symptoms.

Methods: A Phase IV, randomized, single-center, double-blind, placebo-controlled, double-dummy, four-way crossover study was conducted in the EEU. Seventy participants were randomized sequentially into one of the four treatments during ragweed pollen exposure. Nasal and ocular symptom scores were self-reported by the participants and recorded. The original study analysis was carried out by evaluating the nasal symptom scores only. For this post hoc analysis, both nasal and ocular data from the loratadine and placebo treatment arms were analyzed. The primary endpoint for this analysis was the onset of action of loratadine as measured by the change in total symptom score (TSS) from baseline in comparison to placebo. The onset of ocular symptom relief using the total ocular symptom score (TOSS) was also reported.

Results: Loratadine tablets demonstrated a significant and durable improvement in both TSS (P = .005) and TOSS (P = .013) at 75 min post-treatment administration compared to placebo. The mean proportion of participants reporting none or mild for all component symptoms of TSS and TOSS at 75 min and thereafter was significantly higher in the loratadine (TSS, P = .0005; TOSS, P ≤ .0001) vs. placebo treatment arm.

Conclusions: The onset of action of loratadine tablets was 75 min for the relief of nasal and ocular symptoms in adults with SAR. These results suggest a faster onset of action for loratadine tablets (75 min) compared to previously reported studies which were conducted with modified (i.e. gelatin-encapsulated) loratadine tablets (180 min).Trial registration Clinicaltrials.gov identifier NCT00561717.

Keywords: Allergic rhinitis; Environmental Exposure Unit; Loratadine; Onset of action; Outdoor allergy; Ragweed pollen; Seasonal allergies.

Figures

Fig. 1
Fig. 1
Study diagram
Fig. 2
Fig. 2
Change in nasal and ocular symptoms in loratadine and placebo groups during challenge. A significant improvement in TSS (a), TOSS (b), and TNSS (c) was observed at 75 min and remained significant for the remainder of the challenge period. *P ≤ .05, **P ≤ .01, ***P ≤ .001
Fig. 3
Fig. 3
Proportion of participants reporting none or mild nasal and ocular symptoms during challenge. a Mean proportion of participants experiencing none or mild nasal and ocular symptoms was significantly greater in the loratadine group between 75 and 360 min. b Proportion of participants experiencing none or mild nasal and ocular symptoms remained higher in loratadine vs. placebo group at ≥ 75 min. Data are represented as mean ± SD (a only). ***P ≤ .001
Fig. 4
Fig. 4
Proportion of participants reporting none or mild ocular symptoms during challenge. a Mean proportion of participants experiencing none or mild ocular symptoms was significantly greater in the loratadine group between 75 and 360 min. b Proportion of participants experiencing none or mild ocular symptoms remained higher in loratadine vs. placebo group at ≥ 75 min. Data are represented as mean ± SD (a only). ****P ≤ .0001

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