Real-world effectiveness of fluticasone propionate-azelastine nasal spray in moderate-to-severe nonallergic and perennial allergic rhinitis.

BACKGROUND: Although combined intranasal corticosteroid-antihistamine sprays are approved for allergic rhinitis, evidence supporting their effectiveness in nonallergic rhinitis (NAR) remains limited. OBJECTIVE: To compare the treatment response to fluticasone propionate-azelastine (FP-Aze) for treating NAR and perennial allergic rhinitis (PAR). METHODS: This prospective observational real-world study enrolled adults with moderate-to-severe PAR or NAR. Participants received FP-Aze nasal spray (50/137 μg), 1 spray per nostril twice daily for 4 weeks. The primary endpoint was the change from baseline in the visual analog scale (VAS) for rhinitis, ranging from 0 to 100 mm. Treatment effectiveness in NAR was assessed for noninferiority, with a prespecified margin of 23 mm on the VAS relative to PAR. Secondary outcomes included evaluation of non-nasal symptoms and quality of life (QoL). RESULTS: Patients with moderate-to-severe PAR (n = 108) and NAR (n = 62) were included. FP-Aze significantly improved nasal symptoms in both groups. At Week 4, adjusted mean changes (95% CI) in VAS for rhinitis were -52.20 mm (-57.37, -47.03) in PAR and -48.59 mm (-55.64, -41.54) in NAR. The between-group difference in mean change was 3.61 mm (-5.58, 12.79), meeting the noninferiority criterion. QoL improved significantly in both groups, with no significant between-group differences. Sensitivity analyses excluding patients who used as-needed oral antihistamines yielded consistent results. Treatment was well tolerated, with a bitter taste as the most commonly reported adverse event; no serious adverse events were observed. CONCLUSION: The effectiveness of FP-Aze in moderate-to-severe NAR was noninferior to PAR on the VAS for rhinitis, supporting its use in this population. These findings help address an important evidence gap, as data supporting FP-Aze in NAR remain limited.