Onset-of-Efficacy of Azelastine HCl 0.15% Nasal Spray for allergic rhinitis in an environmental exposure chamber.

BACKGROUND: Azelastine nasal spray is effective in relieving symptoms of seasonal and perennial allergic rhinitis. OBJECTIVE: The objective of this single center, double-blinded, placebo-controlled, crossover study was to evaluate the time to onset of efficacy of azelastine HCl 0.15% vs placebo in participants with seasonal allergic rhinitis. METHODS: 110 participants aged 18 to 65 years were randomized to receive azelastine HCl 0.15% two sprays per nostril vs placebo nasal spray after being continuously exposed to ragweed pollen in an environmental exposure chamber (EEC). Symptoms were evaluated subjectively by the total nasal symptom score (TNSS) scale. The primary efficacy parameter was the time to onset of efficacy of azelastine as measured by the change from baseline in TNSS 15, 30, 45, 60, 90, 120, 180, and 240-minute post-dose. RESULTS: The azelastine nasal spray group had statistically significant improvement in TNSS compared with placebo 30 minutes post-dose (p=0.0002), and the effect was sustainable throughout the EEC session for all subsequent time points (p<0.0001). Adverse events were mild, including bitter taste, nasal discomfort, epistaxis, sinusitis, and nausea. No major adverse events were reported during the study. CONCLUSION: Azelastine HCl 0.15% nasal spray relieves nasal symptoms associated with allergic rhinitis and has a fast onset of action within 30 minutes. The overall safety profile of azelastine has also been proven to be safe. These results, along with prior findings on efficacy and improved quality of life for people suffering from allergic rhinitis, establish the important clinical role of azelastine HCl 0.15%.

Barrier-forming, drug-free nasal spray reduces allergic symptoms induced by house dust mite allergen.

BACKGROUND: House Dust Mite (HDM) is the most common indoor allergen triggering allergic symptoms. First-line pharmacotherapy treatment is recommended in international guidelines, while the avoidance of allergens represents a still unmet guideline principle. AM-301 is a new non-pharmacological nasal spray that creates a protective gel-like barrier on the nasal mucosa, preventing the contact with the allergens. METHODS: This randomized, open-label, 3-period crossover study assessed the efficacy and safety of AM-301. The objective was to determine whether AM-301 reduces allergic rhinitis (AR) symptoms in patients exposed to HDM allergens. Adults with confirmed Perennial Allergic Rhinitis (PAR; n = 37) were exposed to HDM allergen in a controlled Allergen Exposure Chamber before and during a treatment course of AM-301 (in six different sequences) within 3 weeks (A: One spray AM-301 per nostril/B: Two sprays AM-301 per nostril/C: no treatment). For the primary efficacy analysis, data from the total nasal symptom score (TNSS) were pooled from treatment A + B (D) and analyzed with Analysis of Covariance Model. As secondary endpoints, single time points, visits and symptoms were analyzed. RESULTS: The primary endpoint (overall change in TNSS from baseline over all three visits) showed significant results (p = 0.0085). A comparable alleviation of all four symptoms (itchy nose, nasal congestion, runny nose, sneezing) by the protective layer started to emerge after 40 min and lasted up to 180 min (end of challenge). AM-301 resulted to be safe and well-tolerated. CONCLUSION: AM-301 significantly reduced HDM-related allergic symptoms in a standardized allergen challenge. Protection was observed to last up to 180 min.