Introduction

1. A 2mg AZELASTINE TABLET IS EFFECTIVE FOR 24h IN ALLERGIC RHINITISL. Klimek, R. Mösges1, W. Lehmacher1, M. Bähre2 German Diagnostics Center, Wiesbaden, Germany1Institute for Medical Statistics, Informatics and Epidemiology, University Hospital of Cologne, Cologne, Germany 2ASTA Medica AG, Frankfurt, Germany Introduction Results Oral Azelastine1 is registered in numerous European countries for the treatment of allergic rhinitis in the dosage of 2mg b.i.d. Unlike topically applied Azelastine which is active for 12 hours2 there is some evidence that one 2mg-tablet of Azelastine may be effective for 24 hours. Objective To demonstrate a 24 hours effect of one 2mg-tablet of Azelastine.0 Study design • double blind • placebo-controlled • 2 period crossover • 20 unsymptomatic patients having a medical history of seasonal • allergic rhinitis Methology • pollen provocation • rhinomanometry • acustic rhinometry • laser doppler perfusion imaging • endoscopy • symptomscores Coures of the trial In a previous study, the patients were exposed to histamine and two specific allergens as identified in an intracutaneous test in order to determine a measurable nasal allergic reaction. In addition, the patients were exposed to isotonic saline solution to document any existing reactions to mechanical irritation. Suitable patients were included in the trial after having been thoroughly informed about the study and after they had signed an informed consent form. In the double-blind study the baseline values were measured for the objective parameters at 6 visits. Then, nasal provocation was performed followed by the renewed determination of the values for rhinomanometry, rhinometry and LDPI as well as the patients’ description of their symptoms. The patient was exposed to his/her specific allergen 24 hours after the intake of the test drug or placebo. At the end of the trial, a final examination was performed including a renewed ENT examination. Discussion In this clinical provocation trial with test subjects who had a medical history of hyperreactivity to seasonally occurring inhalatory allergens, azelastine has again proven itself to be a safe drug when taken repeatedly. In the assessment of symptoms following preseason allergen provocation, the patients showed differences between placebo and test medication. Twenty-four hours after the intake of one tablet containing 2mg of azelastine, the sum scores of nasal symptoms are lower than those for placebo. Obstruction, too, is felt to be less severe after azelastine than after placebo intake. In this respect, an all-day protective effect against allergens can be ascribed to the test medication in this dosage. This effect is reflected only to a small degree in the assessment made by the treating physician just as it is in the measured values which claim to describe nasal obstruction and hyperanemia following allergen provocation. Figure 1: Study flow chart Conclusion Since the differences between the treatment sequences and the model assumptions defined in the protocol are not statistically relevant in every parameter yet are everything else but clinically marginal, it appears justified to carry out a clinical trial with patients under natural pollen exposure during the season using the dosage chosen here. Figure 2: References Study performed by The German Rhinitis Study Group 1 Meltzer, Eli O. et al. J Allergy Clin Immunol 1988; 82: 447-55 2 Greiff, L. et al Clin Exp Allergy, Apr. 1997; 27(4) p438-44