An Observational Study to Determine the Real-Life Effectiveness of MP-AzeFlu® in Austrian Patients with Persistent Allergic Rhinitis.

ABSTRACT

BACKGROUND: Many patients with allergic rhinitis (AR) have moderate-to-severe persistent AR. Meda Pharma's AzeFlu (MP-AzeFlu®) is an intranasal AR treatment comprising a novel formulation of azelastine hydrochloride and fluticasone propionate in a single device. METHODS: This prospective observational study of 214 adults and adolescents in Austria with moderate-to-severe persistent AR assessed the effectiveness of MP-AzeFlu (one spray/nostril twice daily; daily doses azelastine hydrochloride 548 µg; and fluticasone propionate 200 µg) for AR control in clinical practice using the visual analog scale. Symptom severity was reported on days 0, 1, 3, 7, 14, 21, 28, 35, and 42. Patient demographics, AR phenotype, allergen sensitization, symptomatology, AR treatments in the previous year, and the reason for the MP-AzeFlu prescription were recorded. RESULTS: MP-AzeFlu treatment was associated with a rapid and statistically significant reduction in the visual analog scale score from baseline to each timepoint measured, including day 1 (all p < 0.0001). Mean (standard deviation) visual analog scale score was 53.5 mm (26.3) at baseline, 25.3 mm (21.0) on day 28, and 19.6 mm (17.4) on day 42, a mean overall reduction from baseline of 41.4 (23.9) mm for completers. Results were consistent irrespective of patient age, gender, severity, or traditional AR phenotype. Prior to MP-AzeFlu prescription, congestion was considered the most bothersome symptom. The majority of patients reported using at least two AR therapies in the past year, including oral antihistamines, intranasal corticosteroids, and intranasal antihistamines. CONCLUSIONS: Many patients in Austria live with uncontrolled persistent AR despite treatment. MP-AzeFlu provides effective and rapid control of persistent AR in a real-world Austrian setting.