Clinically relevant effect of a new intranasal therapy (MP29-02) in allergic rhinitis assessed by responder analysis.

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