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Background: It is unclear what constitutes a clinically meaningful response for allergic rhinitis (AR) outcomes. The objectives of these post hoc analyses were (1) to define a clinically meaningful response using novel efficacy analyses (including a responder analysis), and (2) to compare the efficacy of MP29-02 [a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP)] with commercially available FP, AZE and placebo in seasonal AR (SAR) patients, using these novel analyses. Methods: 610 moderate-to-severe SAR patients (≥12 years old) were randomized into a double-blind, placebo-controlled, 14-day, parallel-group trial. Change from baseline in the reflective total nasal symptom score (rTNSS) over 14 days was the primary outcome. Post hoc endpoints included the sum of nasal and ocular symptoms (rT7SS), efficacy by disease severity and by predominant nasal symptom, and a set of responder analyses. Results: MP29-02 most effectively reduced rT7SS (relative greater improvement: 52% to FP; 56% to AZE) and both nasal and ocular symptoms irrespective of severity. More MP29-02 patients achieved a ≥30, ≥50, ≥60, ≥75 and ≥90% rTNSS reduction, which occurred days faster than with either active comparator; MP29-02 alone was superior to placebo at the ≥60% (or higher) threshold. One in 2 MP29-02 patients achieved a ≥50% rTNSS reduction and 1 in 6 achieved complete/near-to-complete response. Only MP29-02 was consistently superior to placebo for all patients, whatever their predominant symptom. Conclusions: MP29-02 provided faster and more complete symptom control than first-line therapies. It was consistently superior irrespective of severity, response criteria or patient-type, and may be considered the drug of choice for moderate-to-severe AR. These measures define a new standard for assessing relevance in AR. Copyright © 2013 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Intranasal corticosteroids are considered the most effective therapy for moderate-to-severe seasonal allergic rhinitis (SAR) and recommended first line in guidelines. It is uncertain whether intranasal antihistamines have comparable efficacy. This study was designed to compare the efficacy of azelastine (AZE; 137 μg/spray) and fluticasone propionate (FP; 50 μg/spray), both given as 1 spray/nostril bid (i.e., approved dosing regimen in the United States), in SAR via a post hoc analysis of data from a previously published direct-comparison study. Six hundred ten moderate-to-severe SAR patients (≥12 years old) were randomized into a double-blind, placebo-controlled, parallel-group trial. The primary efficacy variable was change from baseline in reflective total nasal symptom score (rTNSS (morning and evening), over 14 days. Reflective total ocular symptom score (rTOSS) was a key secondary variable. Reflective total of seven symptom scores (rT7SS [nasal plus ocular symptoms]) and time to ≥50% reduction from baseline in these key parameters were also analyzed. AZE and FP reduced rTNSS from baseline by a similar degree (-3.25 versus -3.84; p = 0.2014). Patients experienced comparable improvement in rTOSS (-2.62 versus -2.17; p = 0.2371) and rT7SS (-5.83 versus -6.05; p = 0.7820). FP was superior to AZE in alleviating rhinorrhea (-1.15 versus -0.87; p = 0.0433), but AZE showed comparable efficacy for all other nasal and ocular symptoms. There was no clinically or statistically significant difference between AZE (-1.17) and FP (-1.43) for reduction in the overall rhinitis quality of life questionnaire score (although FP, but not AZE, significantly differed from placebo). A similar proportion of patients in the AZE and FP groups achieved a 50% reduction in rTNSS. However, more AZE patients (53.0%) exhibited a 50% reduction in rTOSS by day 14 versus FP (39.6%), and ≤3 days faster (p = 0.028). Intranasal AZE (137 micrograms/spray) and intranasal FP (50 micrograms/spray), both 1 spray/nostril b.i.d., had comparable efficacy in symptom control in moderate-to-severe SAR. [ABSTRACT FROM AUTHOR]

MP29-02* reduces eosinophil survival induced by epithelial cell secretions from nasal mucosa Keywords: Rhinitis; Allergic Rhinitis; Fluticasone; Fluticasone Propionate; Nasal Mucosa EN Rhinitis Allergic Rhinitis Fluticasone Fluticasone Propionate Nasal Mucosa 1 1 1 03/02/21 20150627 NES 150627 Background Recently, MP29-02* (a novel intranasal formulation of azelastine hydrochloride [AZ] and fluticasone propionate [FP]) has demonstrated significant clinical effects in AR compared to these drugs in monotherapy. Rhinitis, Allergic Rhinitis, Fluticasone, Fluticasone Propionate, Nasal Mucosa. [Extracted from the article]

Keywords: Nasal Cavity; Allergic Rhinitis; Fluticasone; Fluticasone Propionate; Nasal Spray EN Nasal Cavity Allergic Rhinitis Fluticasone Fluticasone Propionate Nasal Spray 1 1 1 03/02/21 20150627 NES 150627 Background Intranasal sprays must be delivered to the nasal cavity in sufficient volume, appropriate viscosity and droplet size and with a technique that allows optimal retention, maximizes absorption from the mucosa, and the potential for maximum therapeutic effect. Nasal Cavity, Allergic Rhinitis, Fluticasone, Fluticasone Propionate, Nasal Spray Deposition characteristics of a new allergic rhinitis nasal spray (MP29-02*) in an anatomical model of the human nasal cavity. [Extracted from the article]