title: A four-way, double-blind, randomized, placebo controlled study to determine the efficacy and speed of azelastine nasal spray, versus loratadine, and cetirizine in adult subjects with allergen-induced seasonal allergic rhinitis.
abstract: BACKGROUND
  Azelastine has been shown to be effective against seasonal allergic rhinitis (SAR). The Environmental Exposure Unit (EEU) is a validated model of experimental SAR. The objective of this double-blind, four-way crossover study was to evaluate the onset of action of azelastine nasal spray, versus the oral antihistamines loratadine 10 mg and cetirizine 10 mg in the relief of the symptoms of SAR.
  
  
  METHODS
  70 participants, aged 18-65, were randomized to receive azelastine nasal spray, cetirizine, loratadine, or placebo after controlled ragweed pollen exposure in the EEU. Symptoms were evaluated using the total nasal symptom score (TNSS). The primary efficacy parameter was the onset of action as measured by the change from baseline in TNSS.
  
  
  RESULTS
  Azelastine displayed a statistically significant improvement in TNSS compared with placebo at all time points from 15 minutes through 6 hours post dose. Azelastine, cetirizine, and loratadine reduced TNSS compared to placebo with an onset of action of 15 (p < 0.001), 60 (p = 0.015), and 75 (p = 0.034) minutes, respectively. The overall assessment of efficacy was rated as good or very good by 46% of the participants for azelastine, 51% of the participants for cetirizine, and 30% of the participants for loratadine compared to 18% of the participants for placebo.
  
  
  CONCLUSIONS
  Azelastine's onset of action for symptom relief was faster than that of cetirizine and loratadine. The overall participant satisfaction in treatment with azelastine is comparable to cetirizine and statistically superior to loratadine. These results suggest that azelastine may be preferential to oral antihistamines for the rapid relief of SAR symptoms.
authors: Division of Allergy & Immunology, Department of Medicine, Queen's University, Kingston, ON, Canada ; Allergy Research Unit, Kingston General Hospital, Kingston, ON, Canada.
authors: Anne K
authors: AK
authors: Ellis
authors: Life Sciences, Queen's University, Kingston, ON, Canada.
authors: Yifei
authors: Y
authors: Zhu
authors: Allergy Research Unit, Kingston General Hospital, Kingston, ON, Canada.
authors: Lisa M
authors: LM
authors: Steacy
authors: Allergy Research Unit, Kingston General Hospital, Kingston, ON, Canada.
authors: Terry
authors: T
authors: Walker
authors: Division of Allergy & Immunology, Department of Medicine, Queen's University, Kingston, ON, Canada ; Allergy Research Unit, Kingston General Hospital, Kingston, ON, Canada.
authors: James H
authors: JH
authors: Day
keywords: Allergic rhinitis; Azelastine; Cetirizine; Environmental exposure unit; Loratadine; Onset of action
references: Allergy Asthma Proc. 2009 May-Jun;30(3):270-6
references: 19549428
references: Am J Rhinol. 2007 Jul-Aug;21(4):499-503
references: 17882923
references: Recent Pat Inflamm Allergy Drug Discov. 2008 Nov;2(3):175-85
references: 19076007
references: Ann Allergy Asthma Immunol. 2007 Sep;99(3):267-72
references: 17910331
references: Allergy Asthma Proc. 2008 May-Jun;29(3):304-12
references: 18387222
references: Ann Allergy Asthma Immunol. 1999 Aug;83(2):83-9; quiz 89-93
references: 10480579
references: Ther Clin Risk Manag. 2008 Oct;4(5):1009-22
references: 19209282
references: Allergy Asthma Proc. 2009 Nov-Dec;30(6):584-8
references: 20031004
references: Eur J Pharmacol. 2011 Nov 30;670(2-3):586-92
references: 21946109
references: Ann Allergy Asthma Immunol. 2006 Feb;96(2):263-77; quiz 277-8, 315
references: 16498847
references: J Allergy Clin Immunol. 1998 May;101(5):638-45
references: 9600501
references: Curr Med Res Opin. 2006 Jan;22(1):151-7
references: 16393441
references: Curr Med Res Opin. 2007 Oct;23(10):2441-52
references: 17723160
references: Allergy Asthma Proc. 2004 Jan-Feb;25(1):59-68
references: 15055564
references: Allergy Asthma Proc. 2009 Nov-Dec;30(6):628-33
references: 19930788
references: Am J Rhinol Allergy. 2009 Sep-Oct;23(5):512-7
references: 19807985
references: Ann Allergy Asthma Immunol. 2003 Aug;91(2):205-11
references: 12952117
references: Allergy. 2000 Feb;55(2):116-34
references: 10726726
references: Eur J Pharmacol. 2006 Oct 10;547(1-3):174-83
references: 16925996
references: Int J Clin Pract. 2004 Feb;58(2):109-18
references: 15055856
references: Allergy Asthma Proc. 2009 Jul-Aug;30(4):345-8
references: 19772756
references: Expert Rev Clin Immunol. 2009 Nov;5(6):659-69
references: 20477689
references: Ann Allergy Asthma Immunol. 2009 Apr;102(4):328-38
references: 19441605
references: Ann Allergy Asthma Immunol. 2009 Nov;103(5):373-80
references: 19927534
references: Allergy Asthma Proc. 2005 Jul-Aug;26(4):275-82
references: 16270720
references: Ann Allergy Asthma Immunol. 2001 Dec;87(6):474-81
references: 11770694
references: Curr Med Res Opin. 2005 Apr;21(4):611-8
references: 15899111
references: Ann Allergy Asthma Immunol. 2010 Apr;104(4):293-8
references: 20408338
references: Allergy Asthma Proc. 2009 Sep-Oct;30(5):512-8
references: 19747429
references: Ann Allergy Asthma Immunol. 2006 Sep;97(3):375-81
references: 17042145
references: Clin Ther. 2005 May;27(5):543-53
references: 15978303