Onset and duration of action of nasal sprays in seasonal allergic rhinitis patients: Olopatadine hydrochloride versus mometasone furoate monohydrate

Abstract

Rapid relief of symptoms should be one of the primary goals of treatment for allergic rhinitis (AR). The onset and duration of action of olopatadine hydrochloride nasal spray, 665 mcg (OLO; Patanese), for seasonal AR (SAR) was evaluated in this study. This study was performed to determine the onset and duration of action of OLO compared with placebo spray, with mometasone furoate monohydrate, 50 mcg (MM; Nasonex), as a reference standard. This was a single center, single-dose, randomized, double-blinded parallel-group environmental exposure chamber study. Patients were primed at two 2-hour priming visits. Eligible patients were randomized to OLO, placebo spray, or MM, 2 sprays/nostril. Allergy symptoms (sneezing, runny, itchy, and stuffy nose) were rated by patients at 16 time points during 12 hours after dosing and patient satisfaction was assessed at 4 and 12 hours postdose. Safety was assessed by a review of adverse events, cardiovascular and nasal examination parameters. Four hundred twenty-five adult patients were randomized. OLO was superior to placebo spray in reducing total nasal symptoms (TNSS) within 30 minutes after dosing and maintained superiority for at least 12 hours (p < 0.05). The onset of MM was not observed until 150 minutes postdose and was smaller in magnitude compared with OLO. OLO was superior to both placebo spray (p < 0.0001) and MM (p < 0.05) in patient satisfaction. Treatment was well-tolerated with no safety concerns. OLO is superior to placebo spray and MM in reducing allergy symptoms; OLO has a rapid onset of action and a duration of effect of at least 12 hours.

Validation Study of the OHIO Chamber in Patients with Japanese Cedar Pollinosis

“…the Vienna Challenge Chamber in Austria [6], the Environmental Exposure Unit in Canada [7, 8] and Germany [9], and the allergen exposure unit in the US [10]. Clinical efficacies and onset and duration of action of antiallergic drugs have been investigated in patients with allergic rhinitis at each facility.…”

Anti-allergic drug testing in an environmental challenge chamber is suitable both in and out of the relevant pollen season

“…This priming effect is even mimicked in some ECC studies by repetitive challenges with the aim to induce higher symptoms. 14,15 Again, this difference did not influence the magnitude of the treatment effect.…”

Controlled Allergen Challenge Facilities and Their Unique Contributions to Allergic Rhinitis Research

“…Olopatadine had an earlier onset of action at 30 min compared to 2.5 h [66]. Olopatadine demonstrated a reduction in TNSS for the duration of the study, up to 12 h post administration of the single dose [66].…”

“…Olopatadine had an earlier onset of action at 30 min compared to 2.5 h [66]. Olopatadine demonstrated a reduction in TNSS for the duration of the study, up to 12 h post administration of the single dose [66]. At Chiba University, cedar pollen allergic individuals were randomized to receive either fexofenadine or mometasone for 7 days to evaluate prophylaxis [67].…”

“…CACFs were also used to compare the efficacy of the intranasal anti-histamine olopatadine to mometasone (50 mcg) in ragweed allergic participants [66]. Olopatadine had an earlier onset of action at 30 min compared to 2.5 h [66].…”