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

Table 2 Overview of MP-AzeFlu’s clinical development programme

Study (NCT or EudraCT number)	Duration	AR phenotype	N (population)	Comparator(s)	References
Pharmacokinetic studies
3282	Single dose	N/A	19 (PP)	Marketed FP and FP in the MP-AzeFlu-based formulation and device	[122]
3283	Single dose	N/A	26 (PP)	Astelin^® and AZE in the MP-AzeFlu formulation and device	[122]
Randomised clinical trials
Adults and adolescents
MP4001 NCT00660517	14 days	SAR	607 (ITT)	Marketed comparators Astelin and generic FP	[118, 125]
MP4002 NCT00651118	14 days	SAR	831 (ITT)	Regulatory comparators AZE and FP in the MP-AzeFlu formulation and device	[121]
MP4004 NCT00740792	14 days	SAR	776 (ITT)
MP4006 NCT00883168	14 days	SAR	1791 (ITT)
MP4000 EudraCT 2011-001368-23	52 weeks	PAR and NAR	611 (safety)	Marketed FP	[128, 129]
Children (aged ≥ 4 to 12 years)
MP4007 NCT01794741	12 weeks	AR	405	Marketed FP	[120]
MP4008 NCT01915823	14 days	SAR	348	Placebo	[130]
Real-life study
NIS 3299	≈ 14 days	SAR and PAR	Germany: 1781 Sweden: 431 Denmark: 170 Norway: 159	None	[123, 124, 126, 127]

AR allergic rhinitis, AZE azelastine hydrochloride, FP fluticasone propionate, ITT intent to treat, MP-AzeFlu a novel formulation of an intranasal antihistamine, azelastine hydrochloride, and an intranasal corticosteroid, fluticasone propionate, in a single spray, N/A not applicable, NAR non-AR, NIS noninterventional study, PAR perennial allergic rhinitis, PP per protocol, SAR seasonal allergic rhinitis

ISSN: 1710-1492