Randomized, double-blind, parallel groups, placebo-controlled study of efficacy and safety of Rynatan in the treatment of allergic rhinitis using an acute model.

We conducted a randomized, double-blind, parallel groups, placebo-controlled acute study of Rynatan (8 mg chlorpheniramine tannate, 25 mg pyrilamine tannate, 25 mg phenylephrine tannate) in 104 volunteers with allergic rhinitis. Subjects reported to City Park on a Saturday morning during the height of the grass pollen season in late spring and remained in the park for eight hours that day and on the following day. Cards were completed hourly to evaluate symptoms of allergic rhinitis and adverse experiences caused by therapy. The first three cards completed on Saturday morning were used to demonstrate that each subject had had at least minimal symptoms of allergic rhinitis and to determine baseline symptoms. Rynatan or placebo was given at noon and 7:30 PM that day and at 8:30 AM the next day. Subjects completed symptom cards hourly until 4:30 PM on Saturday, three cards that evening, and eight cards hourly the next day until 4:30 PM. The group receiving Rynatan had significantly more allergic rhinitis symptom relief than the placebo group (P = .003). More subjects in the Rynatan group (34/52) reported global symptom improvement than did subjects in the placebo group (18/52, P = .002). There were no significant severe adverse experiences and no statistically significant differences between treatment groups in incidence or severity of drowsiness, dizziness, jitteriness, headache, or nausea. We conclude that Rynatan is safe and effective in treating acute symptoms of allergic rhinitis in otherwise healthy adult subjects.