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

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

	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	Formulation effect
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

	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

LS least squares, MP-AzeFlu a novel formulation of an intranasal antihistamine, azelastine hydrochloride, and an intranasal corticosteroid, fluticasone propionate, in a single spray

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