Azelastine hydrochloride and Fluticasone propionate Intranasal Spray Effective in Allergic Rhinitis Symptom Control

13 May, 20

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Introduction

Uncontrolled allergic rhinitis (AR) symptoms adversely affect the general well-being and quality of life in patients with AR, resulting in high patient dissatisfaction. Hence the European Union has prioritized AR control. MACVIA-ARIA (Contre les Maladies Chroniques pour un Vieillissment Actif – Allergic Rhinitis and its Impact on Asthma) has developed an updated AR algorithm for facilitating treatment decisions. A visual analogue scale (VAS) has been endorsed as the new language of AR control and embedded into the most recent MACVIA-ARIA guideline. A novel intranasal formulation of azelastine hydrochloride and fluticasone propionate delivered in a single spray has been effective in symptomatic relief in AR patients.

Aim

This real-life study evaluated the efficacy and safety of novel intranasal spray containing azelastine hydrochloride and fluticasone propionate delivered in a single spray using a VAS, the MACVIA-ARIA – endorsed language of AR control in a cohort of patients in Sweden.

Methods

Study Design

Multicenter, prospective, non-interventional study
The cohort comprised 431 patients aged >12 years with ARIA-defined moderate to severe AR
The novel intranasal spray combining azelastine hydrochloride and fluticasone propionate was prescribed
On day 0 i.e. at the inclusion visit, the patients were required to have acute AR symptoms with a VAS score >50 mm or rated as moderate to severe symptoms by the physician

Endpoints

Symptom severity assessed using a VAS from 0 (not at all bothersome) to 100 mm (very bothersome) on days 0, 1, 3 and 7, and after approximately 14 days in the morning before using the intranasal spray
Patients' perceived level of disease control on day 3.
The proportion of patients who achieved well-controlled or partly-controlled AR symptoms assessed by the defined VAS score cutoff
Adverse events

Results

Use of the intranasal spray significantly reduced mean (SD) VAS score from 67.9 (16.1) mm at baseline to 32.1 (22.8) mm on the last day.
Severity, phenotype, patient age class or previous treatment did not change the outcome and the results were consistent
As per the patient-reported disease control on day 3, 32.6% and 51.4% considered their symptoms well-controlled and partly-controlled respectively
Overall, 84% of patients reported well- or partly controlled symptoms.
The proportion of patients with well-controlled (VAS score cutoff of 38 mm) and partly-controlled (VAS score cutoff of 55 mm) AR symptoms as per the VAS are shown in figure 1.

Figure 1. Proportion of patients with well-controlled and partly-controlled AR symptoms

None of the adverse events were serious

Conclusion

The novel intranasal spray containing azelastine hydrochloride and fluticasone propionate offered rapid, effective and sustained symptom control in Swedish patients with AR in a real-world setting, evaluated by visual analog scale as per the MACVIA-ARIA- endorsed language of AR control
The results were consistent irrespective of the disease severity, phenotype, age class or treatment history.
These findings support the use of this formulation in the treatment of patients with moderate to severe AR

Rhinology. 2019 Aug 1;57(4):279-286. Doi: 10.4193/Rhin18.028.

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