Abstract
This study compared a new intranasal anti-allergic drug, azelastine (0.56 mg bid) with intranasal beclomethasone (0.2 mg bid) and placebo in the treatment of symptoms associated with seasonal rhinitis. After administering placebo for 3–5 days as a “run-in” period, eligible patients were randomized to treatment for 2 weeks: 83 patients received azelastine, 83 beclomethasone and 77 placebo. Each of six symptoms was assessed daily using a four-point scale. Total symptom scores showed that azelastine-treated patients experienced a more rapid onset of overall symptom relief than beclomethasone-treated patients. This was significant on day 1 (P < 0.003) and continued until day 5. By the end of the 2-week study period, the beclomethasone-treated group showed greater improvement than both the azelastine and placebo groups (P = 0.002 andP = 0.0001, respectively). In contrast, visual analogue scales at this time showed no significant differences between the azelastine and beclomethasone treatment groups, with both groups demonstrating significant reductions in total symptom scores compared to placebo (P = 0.0004 andP = 0.0001, respectively). Differing sensitivities were found in the four-point scales reported by the patients and the investigators and the patients' visual analogue scales in the measurement of symptom severity. However, all three techniques confirmed that both azelastine nasal spray and beclomethasone nasal spray were effective treatments for seasonal rhinitis. While a greater improvement in overall symptoms was found for the beclamethasone-treated patients compared to azelastine-treated patients, diary card data confirmed the more immediate onset of symptom relief provided by azelastine. No serious adverse events were found in the present study and included no complaints of drowsiness.
Article PDF
Similar content being viewed by others
Avoid common mistakes on your manuscript.
References
Chand N (1986) Antagonism of histamine and leukotrienes by azelastine in isolated guinea pig ileum. Agents Actions 19:164–168
Davies RJ, Lund VJ, Harten-Ash VJ (1993) The effect of intranasal azelastine and beclomethasone on the symptoms and signs of nasal allergy in patients with perennial allergic rhinitis. Rhinology 31:159–64
Dorow P, Aurich R, Petzold U (1993) Efficacy and tolerability of azelastine nasal spray in patients with allergic rhinitis compared to placebo and budesonide. Arzneimittelforschung/Drug Res 43: 909–911
Gastpar H, Aurich R, Petzold U, Dorow P, et al (1993) Intranasal treatment of perennial rhinitis. Arzneimittelforschung/Drug Res 43:475–479
Gastpar H, Aurich R, Petzold U, et al (1993) Azelastine nasal spray for topical treatment of allergic rhinopathy. Atemwegs Lungenkr 19:148–154
Linder A (1988) Symptom scores as measures of the severity of rhinitis. Clin Allergy 18:29–37
Meltzer E, Orgel H, Bronsky E, et al (1990) A dose ranging study of fluticasone propionate aqueous nasal spray for seasonal allergic rhinitis. J Allergy Clin Immunol 86:221–230
Meltzer EO, Storms WW, Pierson WE, Cummins LH, Orgel HA, et al (1988) Efficacy of azelastine in perennial allergic rhinitis: clinical and rhinometric evaluation. J Allergy Clin Immunol 82:447–455
Weiler JM (1988) Multicenter, double-blind, multiple-dose, parallel-groups efficacy and safety trial of azelastine, chlorpheniramine, and placebo in the treatment of spring allergic rhinitis. J Allergy Clin Immunol 82:801–811
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Newson-Smith, G., Powell, M., Baehre, M. et al. A placebo controlled study comparing the efficacy of intranasal azelastine and beclomethasone in the treatment of seasonal allergic rhinitis. Eur Arch Otorhinolaryngol 254, 236–241 (1997). https://doi.org/10.1007/BF00874095
Received:
Accepted:
Issue Date:
DOI: https://doi.org/10.1007/BF00874095