IPRATROPIUM BROMIDE NASAL SPRAY IN NONALLERGIC RHINITIS - EFFICACY, NASAL CYTOLOGICAL RESPONSE AND PATIENT-EVALUATION ON QUALITY-OF-LIFE

Intranasal fluorocarbon anticholinergic agents have been used to treat the nasal hypersecretion of perennial non-allergic rhinitis, but chro nic use has been restricted either due to the potential for systemic a nticholinergic adverse events or due to the irritating properties of t he fluorocarbon metered dose formulations. This study evaluates a new aqueous nasal formulation of ipratropium bromide (Atrovent Nasal Spray 0.03%) in subjects with perennial non-allergic rhinitis in a double-b lind, placebo-controlled trial. Two hundred and twenty-eight patients were randomized to receive two sprays per nostril of either ipratropiu m bromide (42 mu g/nostril) or placebo-administered three times a day as an aqueous nasal spray over an 8-week interval. Patients were evalu ated bi-weekly and maintained daily diaries for duration and severity of nasal symptoms. Ipratropium bromide reduced the mean severity and d uration of rhinorrhoea within the first week and throughout the 8 week s of active treatment compared with placebo (P < 0.05). Secondary endp oints of efficacy (patient and physician global assessments and a qual ity of life assessment) also supported the use of ipratropium bromide nasal spray for rhinitis symptom control. With the reduction in rhinor rhoea by the ipratropium bromide nasal spray, patients reported a mark ed improvement in daily moods vs placebo (P < 0.01). Both placebo and ipratropium bromide nasal spray induced a modest reduction of nasal co ngestion, sneezing and postnasal drip. This improvement in these other nasal symptoms was consistent with the known soothing effects of a na sal saline vehicle. There were no drug-related serious or systemic ant icholinergic adverse events. The medication was well tolerated with si de-effects limited to infrequent episodes of epistaxis and nasal dryne ss of mild intensity. Assessment for nasal rebound for I week after di scontinuation of treatment showed no increase in nasal symptoms above the original baseline symptoms. These data indicate that ipratropium b romide administered as an 0.03% aqueous nasal spray, 42 mu g/nostril t .i.d., is a well tolerated and a highly effective medication for contr olling the severity and duration of rhinorrhoea in perennial nonallerg ic rhinitis. This new aqueous formulation should provide an additional therapeutic agent to utilize for the chronic treatment of non-allergi c rhinitis.