The aim of this study was to objectively evaluate the effects of intranasal therapy with azelastine (AZE), budesonide (BUD), and combined AZE plus BUD (AZE/BUD) using a nasal provocation test (NPT) and acoustic rhinometry in patients with allergic rhinitis. A randomized, single-blind, crossover study with three treatment sequences was used. Thirty patients with persistent AR received the three treatments using a nasal spray twice daily for 30 days and were evaluated by an NPT with histamine before and after each period of treatment. The treatment comparison, assessed by the nasal responsiveness to histamine, was monitored based on subjective (symptom score) and objective parameters (acoustic rhinometry). The minimal cross-area 2 (MCA2) was measured by acoustic rhinometry at 1, 4, 8, and 12 minutes after NPT for each histamine concentration administered (0.5,1, 2, 4, and 6 mg/mL) up to at least a 20% reduction in the MCA2 from baseline (NPT20). The subjects were scored regarding nasal response encompassing histamine dose and time after histamine administration that caused nasal obstruction (NPT20 score) to assess the treatments' effects. Combination therapy produced a significant increase in baseline MCA2, viz., the improvement of nasal patency (p = 0.005). The symptoms score was significantly decreased after treatment with AZE (p = 0.03), BUD (p < 0.0001), and AZE/BUD (p < 0.0001), compared with pretreatment. The NPT20 score was significantly higher (p = 0.0009) after AZE/BUD, compared with AZE and BUD on their own. Thus, AZE therapy combined with BUD might provide more therapeutic benefits than the isolated drugs for improving nasal patency.
Strong Dose-response Using a Conjunctival Provocation Test During a Phase II Allergen Immunotherapy Study With Subcutaneously Administered Tyrosine Adsorbed Modified Grass Allergen + MPL
