Azelastine hydrochloride and budesonide (nasal sprays): effectiveness combination therapy monitored by acoustic rhinometry and clinical symptom score in the treatment of allergic rhinitis

Methods The study population consisted of 28 patients (9 female and 19 males, aged between 18-32 years) with diagnostic of persistent AR (ARIA consensus). This was a randomized, crossover study. Subjects were randomly assigned to receive either azelastine hydrochloride (140 mcg/nostril) or budesonide (64mcg/nostril) or both drugs. All patients received the three treatments using nasal spray twice daily, each period of treatment lasted 30 days and washout period was 7 days. Subjects were submitted to nasal provocation test (NPT) with histamine before and after each period of treatment. Nasal responsiveness to histamine was monitored based on subjective (symptom score) and objective parameters (acoustic rhinometry) to compare the treatments. After acoustic rhinometry measure (baseline) histamine was instilled in nasal cavity (0.5mg/mL/nostril) via nasal spray. Minimal cross-area (MCA2) was measured by acoustic rhinometry at times 1; 4; 8; and 12 minutes after NPT for each histamine concentration (0.5; 1; 2; 4 and 6 mg/mL) up to positive response occurs (nasal obstruction). The criteria for a positive response were histamine dose and rhinometric measure time causing at least 20% fall in MCA2 (NPT20). NPT was stopped when a positive response occurred. Statistical significance was assessed by paired t-test.