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

Allergy, Asthma and Clinical Immunology

Volumn 9, Issue 1, 2013, Pages

  Ellis, Anne K ^a,b   Zhu, Yifei ^a   Steacy, Lisa M ^b   Walker, Terry ^b   Day, James H ^a,b  

^a QUEEN S UNIVERSITY   (Canada)

^b KINGSTON GENERAL HOSPITAL   (Canada)

Author keywords

Allergic rhinitis; Azelastine; Cetirizine; Environmental exposure unit; Loratadine; Onset of action

Indexed keywords

ALLERGEN; AZELASTINE; CETIRIZINE; LORATADINE; PLACEBO;

ABDOMINAL PAIN; ADULT; AGED; ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DYSGEUSIA; FEMALE; HAY FEVER; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; MYALGIA; NOSE OBSTRUCTION; PATIENT SATISFACTION; PHASE 4 CLINICAL TRIAL; RAGWEED POLLEN; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; SCORING SYSTEM; SINUS HEADACHE; SOMNOLENCE; URTICARIA;

EID: 84877819632     PISSN: 17101484     EISSN: 17101492     Source Type: Journal    
DOI: 10.1186/1710-1492-9-16     Document Type: Article

References (33)

1. Horak F, Zieglmayer UP. Azelastine nasal spray for the treatment of allergic and nonallergic rhinitis. Expert Rev Clin Immunol 2009, 5:659-669. 10.1586/eci.09.38, 20477689.
2. van Cauwenberge P, Bachert C, Passalacqua G. Consensus statement on the treatment of allergic rhinitis. European Academy of Allergology and Clinical Immunology. Allergy 2000, 55:116-134. 10.1034/j.1398-9995.2000.00526.x, 10726726.
3. Leung AK, Hon KL. Seasonal allergic rhinitis. Recent Pat Inflamm Allergy Drug Discov 2008, 2:175-185. 10.2174/187221308786241965, 19076007.
4. Slack RJ, Hart AD, Luttmann MA, Clark KL, Begg M. In vitro characterisation of the duration of action of the histamine-1 receptor antagonist azelastine. Eur J Pharmacol 2011, 670:586-592. 10.1016/j.ejphar.2011.09.017, 21946109.
5. Shah S, Berger W, Lumry W, La Force C, Wheeler W, Sacks H. Efficacy and safety of azelastine 0.15% nasal spray and azelastine 0.10% nasal spray in patients with seasonal allergic rhinitis. Allergy Asthma Proc 2009, 30:628-633. 10.2500/aap.2009.30.3296, 19930788.
6. van Bavel J, Howland WC, Amar NJ, Wheeler W, Sacks H. Efficacy and safety of azelastine 0.15% nasal spray administered once daily in subjects with seasonal allergic rhinitis. Allergy Asthma Proc 2009, 30:512-518. 10.2500/aap.2009.30.3284, 19747429.
7. Horak F. Effectiveness of twice daily azelastine nasal spray in patients with seasonal allergic rhinitis. Ther Clin Risk Manag 2008, 4:1009-1022. 2621402, 19209282.
8. Lumry W, Prenner B, Corren J, Wheeler W. Efficacy and safety of azelastine nasal spray at a dose of 1 spray per nostril twice daily. Ann Allergy Asthma Immunol 2007, 99:267-272. 10.1016/S1081-1206(10)60663-1, 17910331.
9. Bernstein JA, Prenner B, Ferguson BJ, Portnoy J, Wheeler WJ, Sacks HJ. Double-blind, placebo-controlled trial of reformulated azelastine nasal spray in patients with seasonal allergic rhinitis. Am J Rhinol Allergy 2009, 23:512-517. 10.2500/ajra.2009.23.3396, 19807985.
10. Lieberman P. Intranasal antihistamines for allergic rhinitis: mechanism of action. Allergy Asthma Proc 2009, 30:345-348. 10.2500/aap.2009.30.3263, 19772756.
11. Kaliner MA. Azelastine and olopatadine in the treatment of allergic rhinitis. Ann Allergy Asthma Immunol 2009, 103:373-380. 10.1016/S1081-1206(10)60355-9, 19927534.
12. Bernstein JA. Azelastine hydrochloride: a review of pharmacology, pharmacokinetics, clinical efficacy and tolerability. Curr Med Res Opin 2007, 23:2441-2452. 10.1185/030079907X226302, 17723160.
13. Hernandez-Trujillo V. Antihistamines treatment for allergic rhinitis: different routes, different mechanisms?. Allergy Asthma Proc 2009, 30:584-588. 10.2500/aap.2009.30.3289, 20031004.
14. Day JH, Briscoe MP. Environmental exposure unit: a system to test anti-allergic treatment. Ann Allergy Asthma Immunol 1999, 83:83-89. quiz 89-93, 10.1016/S1081-1206(10)62616-6, 10480579.
15. Day JH, Ellis AK, Rafeiro E, Ratz JD, Briscoe MP. Experimental models for the evaluation of treatment of allergic rhinitis. Ann Allergy Asthma Immunol 2006, 96:263-277. 10.1016/S1081-1206(10)61235-5, 16498847.
16. Ellis AK. Why use an environmental exposure unit to study allergic rhinitis?. Asthma Allergies Children 2012, online guest editorial.
17. Day JH, Briscoe MP, Rafeiro E, Hewlett D, Chapman D, Kramer B. Randomized double-blind comparison of cetirizine and fexofenadine after pollen challenge in the Environmental Exposure Unit: duration of effect in subjects with seasonal allergic rhinitis. Allergy Asthma Proc 2004, 25:59-68.
18. Day JH, Briscoe MP, Rafeiro E, Ratz JD. Comparative clinical efficacy, onset and duration of action of levocetirizine and desloratadine for symptoms of seasonal allergic rhinitis in subjects evaluated in the Environmental Exposure Unit (EEU). Int J Clin Pract 2004, 58:109-118. 10.1111/j.1368-5031.2004.0117.x, 15055856.
19. Day JH, Briscoe MP, Rafeiro E. Comparative efficacy of cetirizine and fexofenadine for seasonal allergic rhinitis, 5-12 hours postdose, in the environmental exposure unit. Allergy Asthma Proc 2005, 26:275-282.
20. Day JH, Briscoe MP, Ratz JD. Efficacy of levocetirizine compared with montelukast in subjects with ragweed-induced seasonal allergic rhinitis in the Environmental Exposure Unit. Allergy Asthma Proc 2008, 29:304-312. 10.2500/aap.2008.29.3109, 18387222.
21. Day JH, Briscoe MP, Ratz JD, Danzig M, Yao R. Efficacy of loratadine-montelukast on nasal congestion in patients with seasonal allergic rhinitis in an environmental exposure unit. Ann Allergy Asthma Immunol 2009, 102:328-338. 10.1016/S1081-1206(10)60339-0, 19441605.
22. Day JH, Briscoe MP, Ratz JD, Ellis AK, Yao R, Danzig M. Onset of action of loratadine/montelukast in seasonal allergic rhinitis subjects exposed to ragweed pollen in the Environmental Exposure Unit. Allergy Asthma Proc 2009, 30:270-276. 10.2500/aap.2009.30.3234, 19549428.
23. Ellis AK, Ratz JD, Day AG, Day JH. Factors that affect the allergic rhinitis response to ragweed allergen exposure. Ann Allergy Asthma Immunol 2010, 104:293-298. 10.1016/j.anai.2010.01.012, 20408338.
24. Astelin® (azelastine hydrochloride) Nasal Spray [prescribing information] 2006, Somerset, NJ: MedPointe Healthcare, Astelin® (azelastine hydrochloride) Nasal Spray.
25. Horak F, Zieglmayer UP, Zieglmayer R. Azelastine nasal spray and desloratadine tablets in pollen-induced seasonal allergic rhinitis: a pharmacodynamic study of onset of action and efficacy. Curr Med Res Opin 2006, 22:151-157. 10.1185/030079906X80305, 16393441.
26. Patel P, D'Andrea C, Sacks HJ. Onset of action of azelastine nasal spray compared with mometasone nasal spray and placebo in subjects with seasonal allergic rhinitis evaluated in an environmental exposure chamber. Am J Rhinol 2007, 21:499-503. 10.2500/ajr.2007.21.3058, 17882923.
27. Hanashiro K, Sunagawa M, Tokeshi Y. Antiallergic drugs, azelastine hydrochloride and epinastine hydrochloride, inhibit ongoing IgE secretion of rat IgE-producing hybridoma FE-3 cells. Eur J Pharmacol 2006, 547:174-183. 10.1016/j.ejphar.2006.07.012, 16925996.
28. Lieberman P, Kaliner MA, Wheeler WJ. Open-label evaluation of azelastine nasal spray in patients with seasonal allergic rhinitis and nonallergic vasomotor rhinitis. Curr Med Res Opin 2005, 21:611-618. 10.1185/030079905X41408, 15899111.
29. Day JH, Briscoe M, Widlitz MD. Cetirizine, loratadine, or placebo in subjects with seasonal allergic rhinitis: effects after controlled ragweed pollen challenge in an environmental exposure unit. J Allergy Clin Immunol 1998, 101:638-645. 10.1016/S0091-6749(98)70172-1, 9600501.
30. Day JH, Briscoe M, Rafeiro E, Chapman D, Kramer B. Comparative onset of action and symptom relief with cetirizine, loratadine, or placebo in an environmental exposure unit in subjects with seasonal allergic rhinitis: confirmation of a test system. Ann Allergy Asthma Immunol 2001, 87:474-481. 10.1016/S1081-1206(10)62260-0, 11770694.
31. Corren J, Storms W, Bernstein J. Effectiveness of azelastine nasal spray compared with oral cetirizine in patients with seasonal allergic rhinitis. Clin Ther 2005, 27:543-553. 10.1016/j.clinthera.2005.04.012, 15978303.
32. Berger W, Hampel F, Bernstein J, Shah S, Sacks H, Meltzer EO. Impact of azelastine nasal spray on symptoms and quality of life compared with cetirizine oral tablets in patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol 2006, 97:375-381. 10.1016/S1081-1206(10)60804-6, 17042145.
33. Berger WE, White MV. Efficacy of azelastine nasal spray in patients with an unsatisfactory response to loratadine. Ann Allergy Asthma Immunol 2003, 91:205-211. 10.1016/S1081-1206(10)62179-5, 12952117.