Effectiveness of twice daily azelastine nasal spray in patients with seasonal allergic rhinitis

Abstract

Azelastine nasal spray (Allergodil((R)), Lastin((R)), Afluon((R)); Meda AB, Stockholm, Sweden) is a fast-acting, efficacious and well-tolerated H1-receptor antagonist for the treatment of rhinitis. In addition it also has mast-cell stabilizing and anti-inflammatory properties, reducing the concentration of leukotrienes, kinins and platelet activating factor in vitro and in vivo, as well as inflammatory cell migration in rhinitis patients. Well-controlled studies in patients with seasonal allergic rhinitis (SAR), perennial rhinitis (PR) or vasomotor rhinitis (VMR) confirm that azelastine nasal spray has a rapid onset of action, and improves nasal symptoms associated with rhinitis such as nasal congestion and post-nasal drip. Azelastine nasal spray is effective at the lower dose of 1 spray as well at a dose of 2 sprays per nostril twice daily, but with an improved tolerability profile compared to the 2-spray per nostril twice daily regimen. Compared with intranasal corticosteroids, azelastine nasal spray has a faster onset of action and a better safety profile, showing at least comparable efficacy with fluticasone propionate (Flonase((R)); GSK, USA), and a superior efficacy to mometasone furoate (Nasonex((R)); Schering Plough, USA). In combination with fluticasone propionate, azelastine nasal spray exhibits greater efficacy than either agent used alone, and this combination may provide benefit for patients with difficult to treat seasonal allergic rhinitis. In addition, azelastine nasal spray can be used on an as-needed basis without compromising clinical efficacy. Compared with oral antihistamines, azelastine nasal spray also demonstrates superior efficacy and a more rapid onset of action, and is effective even in patients who did not respond to previous oral antihistamine therapy. Unlike most oral antihistamines, azelastine nasal spray is effective in alleviating nasal congestion, a particularly bothersome symptom for rhinitis sufferers. Azelastine nasal spray is well tolerated in both adults and children with allergic rhinitis. Bitter taste which seems to be associated with incorrect dosing technique is the most common side effect reported by patients, but this problem can be minimized by correct dosing technique.

Keywords: azelastine nasal spray; intranasal corticosteroids; oral antihistamines; rhinitis; seasonal allergic rhinitis.

Figure 1

Number needed to treat a global assessment of efficacy as an outcome for azelastine nasal spray compared with oral agents for the treatment of allergic rhinitis. Reprinted with permission from Lee T, Pickard S. 2007. Meta-analysis of azelastine nasal spray for the treatment of allergic rhinitis. Pharmcotherapy, 27:852–9. Copyright © 2007 Pharmcotherapy Publications. Abbreviations: CI, confidence interval; NNT, number needed to treat.

Figure 2

Onset of action of azelastine hydrochloride nasal spray in relieving nasal symptoms of seasonal allergic rhinitis. *p < 0.001 azelastine vs placebo; *p ≤ 0.001 azelastine vs mometasone; mometasone vs placebo = not significant. Reprinted with permission from Patel P, D’Andrea C, Sacks HJ. 2007. 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, 21:499–503. Copyright © 2007 Oceanside Publications.

Figure 3

Effect of azelastine nasal spray or fluticasone propionate nasal spray on Rhinitis Quality of Life Questionnaire (RQLQ) scores in geriatric patients with either allergic or non-allergic rhinitis. Reprinted with permission from Behncke VB, Alemar GO, Kaufman DA, et al 2006. Azelastine nasal spray and fluticasone nasal spray in the treatment of geriatric patients with rhinitis. J Allergy Clin Immunol, 117:263. Copyright © 2006 Elsevier. Abbreviations: AZ, azelastine; FP, fluticasone.

Figure 4

Effect of azelastine nasal spray or fluticasone propionate nasal spray on Total Daily Symptom Score (TDSS) in geriatric patients with either allergic or non-allergic rhinitis. Reprinted with permission from Behncke VB, Alemar GO, Kaufman DA, et al 2006. Azelastine nasal spray and fluticasone nasal spray in the treatment of geriatric patients with rhinitis. J Allergy Clin Immunol, 117:263. Copyright © 2006 Elsevier.

Figure 5

Major nasal symptom scores averaged over treatment and time for the per protocol population after administration of azelastine (1 spray per nostril), desloratadine (5 mg), or placebo in patients with SAR. Reprinted with permission from Horak F, Zieglmayer UP, Zidglmayer R, et al 2006. Azelastine nasal spray and desloratadine tablets in pollen-induced seasonal allergic rhinitis: a pharmacodynamic study of onset of action and efficacy. Curr Med Res Opion, 22:151–7. Copyright © 2006 LibraPharm.

Figure 6

Major nasal symptom and mean nasal symptom scores after administration of azelastine nasal spray (1 spray per nostril), desloratadine (5 mg) or placebo in patients with SAR: absolute changes of last value (6 hours after the start of challenge) compared to predose (ie, 2 hours after the start of the challenge). Reprinted with permission from Horak F, Zieglmayer UP, Zidglmayer R, et al 2006. Azelastine nasal spray and desloratadine tablets in pollen-induced seasonal allergic rhinitis: a pharmacodynamic study of onset of action and efficacy. Curr Med Res Opion, 22:151–7. Copyright © 2006 LibraPharm.

Figure 7

Mean daily improvements from baseline to day 14 in combined morning and evening 12-hour reflective total nasal symptom scores (TNSSs). *p < 0.05 versus cetirizine. Reprinted with permission from Berger W, Hampel F, Bernstein J, et al 2006. 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, 97:375–81. Copyright © 2006 American College of Allergy, Asthma and Immunology.

Figure 8

Mean improvement from baseline to day 14 in overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score and individual RQLQ domain scores (intention-to-treat population). *p ≤ 0.05 vs cetirizine; **p < 0.01 vs cetirizine. Reprinted with permission from Berger W, Hampel F, Bernstein J, et al 2006. 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, 97:375–81. Copyright © 2006 American College of Allergy, Asthma and Immunology.