DOUBLE-BLIND-STUDY OF THE COMBINATION OF NAAGA PLUS CETIRIZINE COMPARED TO THE COMBINATION OF PLACEBO PLUS CETIRIZINE IN ADULT POLLINIC RHINITIS

The aim of this trial was to confirm the therapeutic benefit obtained when a NAAGA nasal spray was associated with oral H-1 antihistamine tr eatment. Cetirizine was chosen as the antihistamine reference drug as it is currently the most widely prescribed drug in pollinosis. To ensu re the accuracy of the results, this study was conducted under double- blind conditions. Eighteen centres participated during spring '93 and '94. Ambulatory adults, suffering from pollinic rhinitis were eligible if their initial nasal score (sum of the three symptoms : nasal obstr uction, rhinorrhea and sneezing, each rated from 0 to 3) was at least 5/9. Treatment duration was one week. Cetirizine dosage was one 10 mg tablet once a day in the evening. The spray dosage (containing either NAAGA or placebo) was a double spray in each nostril, 5 times a day. T he main efficacy criterion (nasal score) was obtained for 206 patients (99 received NAAGA + cetirizine and 107 received placebo + cetirizine ), among the 218 patients included. The rapid success (nasal score = 0 or 1 after one week) frequency was 40.4 per cent with NAAGA and 28.0 per cent with placebo (statistically significant difference - p < 0.05 ). The increase of the relative success rate when NAAGA spray was adde d can be estimated to be about 44 per cent after one week of treatment (95 % confidence interval : [- 2, + 112]). The analysis of each of th e clinical signs describing the nasal mucosa impairment indicates a hi gher frequency of relieved patients in the NAAGA group for sneezing an d nasal obstruction (p < 0,02). 90 per cent of the patients rated the overall treatment tolerance as good or very good. 2.8 per cent stopped for adverse events, all benign. The 2 groups were similar for all tol erance parameters. Thus, the association of a NAAGA nasal spray with a n oral H, antihistamine treatment is a well tolerated bi-therapy. It i nduces an increase of the relative success rate which can be estimated to be about 44 per cent after one week of treatment. The clinical imp rovement mainly concerned sneezing and nasal obstruction.