title: Efficacy and safety of azelastine 0.15% nasal spray administered once daily in patients with allergy to Texas mountain cedar pollen.
abstract: BACKGROUND
  A previous study with azelastine nasal spray in patients with seasonal allergic rhinitis (SAR) demonstrated that increasing the azelastine concentration from 0.1% to 0.15% allowed for once-daily dosing without increasing the incidence of adverse effects. This study evaluated the efficacy of azelastine 0.15% nasal spray administered once daily for treating symptoms of SAR.
  
  
  METHODS
  In this 14-day, randomized, double-blind, placebo-controlled study, patients with moderate-to-severe SAR were randomized to azelastine 0.15% (n = 251) or placebo (n = 255), both at a dosage of 2 sprays/nostril once daily. The primary efficacy variable was change from baseline in the 12-hour reflective Total Nasal Symptom Score (TNSS). Key secondary variables were change from baseline in 24-hour instantaneous TNSS, to establish the dosing interval, and change from baseline in the Total Ocular Symptom Score (TOSS).
  
  
  RESULTS
  The mean improvement (3.57) and percentage improvement (19.3%) in 12-hour reflective TNSS was significant (p < 0.012) with azelastine 0.15% compared to placebo (2.14 and 11.4%, respectively). The mean improvement in 24-hour instantaneous TNSS was also significant (p < 0.001) for azelastine 0.15% compared to placebo, indicating efficacy with once-daily dosing. The overall improvement and percentage improvement in TOSS was significant (p ≤ 0.012) with azelastine 0.15% (2.21 and 16.7%, respectively) compared to placebo (1.28 and 6.0%, respectively). The overall score for the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was significantly (p < 0.001) improved from baseline in the azelastine group compared with the placebo group. Nasal discomfort (3.6%) and bitter taste (2.4%) were the most common adverse events. There were no reports of somnolence with azelastine.
  
  
  CONCLUSIONS
  Azelastine 0.15% was effective and well tolerated with once-daily dosing. Azelastine 0.15% nasal spray significantly improved a complex of eye symptoms compared to placebo.
authors.affiliation: Allergy and Asthma Center of Austin, Austin, TX, USA.
authors.forename: William C
authors.initials: WC
authors.lastname: Howland
authors.forename: Niran J
authors.initials: NJ
authors.lastname: Amar
authors.forename: William
authors.initials: W
authors.lastname: Wheeler
authors.forename: Harry
authors.initials: H
authors.lastname: Sacks
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000485:Allergens / Q000009:adverse effects*; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D018653:Juniperus; D008297:Male; D008875:Middle Aged; D059085:Nasal Sprays; D010793:Phthalazines / Q000008:administration & dosage* / Q000009:adverse effects; D011058:Pollen / Q000009:adverse effects*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000485:Allergens; D018926:Anti-Allergic Agents; D059085:Nasal Sprays; D010793:Phthalazines; C020976:azelastine