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Table 3 Contribution of MP-AzeFlu’s formulation to its superior efficacy over fluticasone propionate (FP), measured for reflective total nasal symptom score (rTNSS), reflective total ocular symptom score (rTOSS), and time to achieve ≥ 50% reduction from baseline in rTNSS

From: The complex pathophysiology of allergic rhinitis: scientific rationale for the development of an alternative treatment option

  Study MP4001 [118] (effect of formulation included) Studies MP4002/MP4004/MP4006 [121] (effect of formulation removed) Formulation effect
Parameter MP-AzeFlu n = 153 Marketed FP n = 151 MP-AzeFlu–FP MP-AzeFlu n = 848 Reformulated-FP n = 846 MP-AzeFlu–FP
LS mean rTNSS (95% CI) − 5.31 − 3.84 − 1.47 (− 2.44, − 0.50) p = 0.003 − 5.56 − 4.80 − 0.76 (− 1.18, − 0.34) p = 0.0004 0.71 points
LS mean rTOSS (95% CI) − 3.33 − 2.17 − 1.17 (− 1.91, − 0.42) p = 0.002 − 3.18 − 2.71 − 0.47 (− 0.78, − 0.16) p = 0.0030 0.71 points
  1. LS least squares, MP-AzeFlu a novel formulation of an intranasal antihistamine, azelastine hydrochloride, and an intranasal corticosteroid, fluticasone propionate, in a single spray
  Patients at day 14, % No. days’ advantage over FP Patients at day 14, % No. days’ advantage over FP  
≥ 50 reduction from baseline rTNSS 49.1 38.2 ≤ 6 days p = 0.0284 ~ 50 ≈ 45 ≤ 3 days (significance not provided) ≤ 3 days
  1. LS least squares, MP-AzeFlu a novel formulation of an intranasal antihistamine, azelastine hydrochloride, and an intranasal corticosteroid, fluticasone propionate, in a single spray