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

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

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
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]
  1. 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