A new allergic rhinitis therapy (MP29-02*) provides effective and rapid symptom relief for patients who suffer most from the bothersome symptoms of nasal congestion or ocular itch

摘要

BackgroundAllergic rhinitis (AR) patients often present with a predominantsymptom. Nasal congestion and ocular symptomshave the greatest negative impact on patients’ quality oflife [1]. Our aim was to assess the efficacy of MP29-02*(a novel intranasal formulation of azelastine hydrochloride[AZE] and fluticasone propionate [FP] in an advanceddelivery system) in seasonal AR (SAR) patients presentingwith nasal congestion or ocular itch predominantly comparedto AZE, FP or placebo (PLA) nasal sprays.Methods610 patients (≥12 yrs old) with moderate/severe SARwere randomized into a double-blind, PLA-controlled,14-day, parallel-group trial to MP29-02*, AZE FP orPLA nasal sprays (all 1 sprayostril bid [total dailydoses: AZE 548μg; FP 200μg]). Patients were categorizedas nasal congestion- or ocular itch-predominant (forthose patients with baseline rTOSS ≥ 8) according tomaximal symptom scores at baseline. Targeted symptomreduction was assessed for each predominant symptomover the entire 14 day period and on each day.ResultsCongestion-predominant MP29-02*-patients experienced3 times the congestion relief of FP-patients (p=0.0018) and5 times the relief provided by AZE (p=0.0001). AZE andFP did not significantly differ from PLA. Superior congestionrelief afforded by MP29-02* in these patients was evidentfrom Day 2 vs FP (p=0.0155), AZE (p=0.0032) andPLA (p=0.0010) and sustained for 14 days. The level ofrelief achieved by MP29-02* patients on Day 2 (-0.90) wasnot achieved before Day 9 by either FP or AZE patients.Ocular itch predominant MP29-02*-patients experienced4 times the ocular itch relief as FP-patients (p=0.0026) andtwice the relief provided by AZE (p=0.0551). FP did notprovide additional ocular itch relief over the placeboresponse. The level of ocular itch relief achieved by MP29-02* patients on Day 2 (-0.93) was not achieved before Day9 by FP patients or before Day 4 by AZE patients.ConclusionUnlike currently available first line therapy, MP29-02*effectively and rapidly reduced nasal congestion andocular itch in patients suffering predominantly fromthese symptoms. MP29-02*’s rapidity and effectivenessin relieving predominant congestion and ocular itchcould lead to a reduction in the need for concomitantdecongestants and eye drops, respectively and furthersupports the position of MP29-02* as the drug of choicefor the treatment of AR.