Patient-Reported Symptoms Induced By Allergic and Non-Allergic Triggers in Randomized Controlled Trials of MP-Azeflu (Dymista) in Seasonal Allergic Rhinitis (SAR) Patients

Rationale: MP-AzeFlu is an intranasal formulation of fluticasone propionate (FP) and azelastine HCl (AZE) in a single delivery device for the treatment of SAR.  However, many individuals with SAR also report symptoms in response to non-allergic triggers.  In NDA registration studies, which found that MP-AzeFlu was superior to monotherapy with FP and AZE in treating SAR, a rhinitis questionnaire was used to identify specified patient demographic and clinical characteristics.

Methods: Upon enrollment, patients (n=3398) completed a questionnaire that elicited information on age at symptom onset, parental history, types of symptoms experienced, symptoms induced by allergic and non-allergic triggers, and response to previous medications.

Results: Patients were on average 37.3 years old with a mean age at onset of allergic symptoms at 15.6 years.  Stuffy nose (94.4%) was the most frequently reported nasal symptom and itchy/watery eyes (93.6%) was the most common ocular symptom. Temperature changes (71.4%), tobacco smoke (60.8%), perfumes (56.4%), and cleaning products (37.9%) were the most frequently reported non-allergic triggers, and more than 90% of patients reported symptoms in response to at least one non-allergic trigger. Less than 16% of patients reported a big effect from previous medications, including intranasal corticosteroids, oral antihistamines, and intranasal antihistamines.

Conclusions: A large proportion of SAR patients reported symptoms in response to non-allergic triggers suggesting a high percentage of patients with SAR had a non-allergic component (mixed rhinitis).  The efficacy of MP-AzeFlu in this study population suggests that, in addition to SAR, MP-AzeFlu may also be effective for treatment of patients with mixed or non-allergic rhinitis.