Ipratropium bromide nasal spray 0.03% provides additional relief from rhinorrhea when combined with terfenadine in perennial rhinitis patients; A randomized, double-blind, active-controlled trial

Medical treatment of perennial rhinitis is aimed at providing symptomatic r elief of individual symptoms. Multiple agents are administered when no sing le agent provides complete relief Studies assessing the benefit/risk of com bined therapy are important, especially for newly available agents such as ipratropium bromide nasal spray, a topical anticholinergic agent approved f or the treatment of rhinorrhea in allergic and nonallergic perennial rhinit is. The objective was to determine whether the combined use of ipratropium bromide nasal spray 0.03% (42 mcg per nostril) administered three time's da ily with a nonsedating antihistamine (terfenadine, 60 mg administered twice daily) is safe and provides greater clinical benefit than use of the place bo nasal spray plus terfenadine. Our method was a multicenter, 6-week, doub le-blind, randomized active-controlled crossover trial of 205 patients with perennial rhinitis (114 allergic and 91 nonallergic), 18 to 75 years of ag e, who had clinically significant rhinorrhea. After a 1-week run-in period, patients were treated for 2 weeks with one of the two treatment regimens, followed by a 1-week washout period and then were treated for another 2 wee ks with the other treatment regimen. Daily diary symptoms scores of rhinorr hea, congestion, and sneezing were obtained, as well as biweekly patient an d physician global assessments of treatment effectiveness of each of the na sal symptoms. Ipratropium bromide nasal spray plus terfenadine was more eff ective than vehicle plus terfenadine in reducing the average severity (38% versus 28%) and duration (46% versus 30%) of rhinorrhea during the 2 weeks of treatment from baseline (p < 0.05). The advantage of ipratropium bromide nasal spiny plus terfenadine evident by the second day of treatment and co ntinued throughout the 2-week treatment period. Of patients who responded m ore to one treatment than another, 69% responded to ipratropium bromide nas al spray terfenadine, compared to 31% to vehicle plus terfenadine (p < .005 ). Both physicians and patients rated control of rhinorrhea and sneezing by ipratropium bromide nasal spray plus terfenadine as superior to vehicle pl us terfenadine (p < 0.05). The symptom of congestion was controlled equally well by both treatments. Combined active therapy was self tolerated with n o increase in adverse events over that seen previously with ipratropium bro mide nasal spray alone. The combination of ipratropium bromide nasal spray with terfenadine is more effective than vehicle plus terfenadine for the tr eatment of rhinorrhea, and does not result in a potentiation of adverse dru g reactions.