EFFICACY OF INTRANASALLY APPLIED DIMETHINDENE MALEATE SOLUTION AS SPRAY IN ADULT VOLUNTEERS WITH SYMPTOMS OF SEASONAL ALLERGIC RHINITIS IN THE VIENNA CHALLENGE CHAMBER

Twelve asymptomatic subjects (4 female, 8 male), being allergic to gra ss pollen proved by positive anamnesis, positive Prick-test and positi ve nasal provocation test, were challenged under controlled conditions with purified airborne grass pollen of Dactylis glomerata in the Vien na Challenge Chamber (VCC), located at the Universitatsklinik fur Hals -Nasen-Ohrenheilkunde, Allgemeines Krankenhaus (AKH), der Stadt Wien, Vienna (Austria) by means of a double-blind, randomised, cross-over de sign, with 2 weeks wash-out periods between. Efficacy and safety of 2 concentrations of dimethindene (dimethindene maleate; DMM, CAS 3614-69 -5, Fenistil(R) reap. Foristal(R)) (0.025 % DMM, 0.1 % DMM) were teste d vs placebo as negative control and vs 0.1% azelastine as positive co ntrol, as topical nasal sprays. The tested nasal sprays were applied a s single doses in the morning (2 puffs = 0.28 mi of the respective sol ution) to each nostril 15 min before the start of the 4 h lasting prov ocation procedure in the VCC, thus representing a total daily dose of 0.14 mg resp. 0.56 mg DMM and 0.56 mg azelastine, respectively. Compar ed to placebo, the objective variables nasal flow (150 Pa., measured b y active anterior rhinomanometry) and nasal secretion (g), showed simi lar onset of antiobstructive and antisecretory effects in the nose aft er 0.1% DMM and 0.1% azelastine, respectively. The same applied for th e subjective nasal symptom complex and for nasal symptom scores, evalu ated by Visual Analog Scale (VAS): Time curves showed statistically si gnificant and clinically relevant superiority of 0.1 % DMM and 0.1 % a zelastine vs placebo, during the 4 h lasting provocation period. 0.025 % DMM was not significantly different from placebo. No systemic adver se events were reported after the 4 tested preparations. Only a total of 3 subjects reported very slight local irritations (1 subject after placebo, 1 subject after 0.025 % DMM and 1 subject after 0.1 % azelast ine). However, after 0.1 % DMM no local adverse events were reported. It is concluded from this study that 0.1% DMM as nasal spray, is an ef ficient and safe galenical formulation for nasal spray application for patients suffering from seasonal allergic rhinitis (SAR).