Ipratropium bromide nasal spray 0.03% and beclomethasone nasal spray aloneand in combination for the treatment of rhinorrhea in perennial rhinitis

Background: Perennial rhinitis is a common condition that affects up to 10% to 20% of the population. Multiple agents an frequently administered since no single agent provides complete relief. Studies assessing the benefit/ri sk of combined therapy are important especially for newly approved agents s uch as ipratropium bromide nasal spray 0.03%, a topical anticholinergic age nt, approved specifically for the treatment of rhinorrhea in allergic and n on-allergic perennial rhinitis, Objective: To compare the efficacy and safety of the combined use of ipratr opium bromide nasal spray 0.03% (42 mu g per nostril tid) and beclomethason e dipropionate nasal spray (84 mu g per nostril bid) against that of either active agent alone for the treatment of rhinorrhea. Design: Multicenter, 6-week, double-blind, randomized active- and placebo-c ontrolled, parallel trial. Setting: Allergist and general practitioner clinical practices. Patients: Five hundred thirty-three patients with perennial rhinitis (279 a llergic and 274 non-allergic), 8 to 75 years of age, who had at least a mil d degree of severity of rhinorrhea for a minimum of 2 hours per day during the I week screening period as well as congestion or sneezing also of at le ast mild severity. Intervention: Either (1) ipratropium bromide nasal spray 0.03% (42 mu g per nostril tid) plus beclomethasone dipropionate nasal spray (84 mu g per nos tril bid), (2) ipratropium bromide nasal spray 0.03% (42 mu g per nostril t id) alone, (3) beclomethasone dipropionate nasal spray (84 mu g per nostril bid) alone, or (4) vehicle [matching placebo nasal spray for the ipratropi um bromide (2 sprays per nostril tid)] or beclomethasone dipropionate (2 sp rays per nostril bid). Main Outcome Measure: Severity and duration of rhinorrhea, and patient and physician global assessment of control of rhinorrhea. Results: Ipratropium bromide nasal spray plus beclomethasone nasal spray was more effective than either active agent alone or vehicle in reducing the average severity and duration of rhinorrhea during 4 weeks of treatment. The advantage of ipratr opium bromide plus beclomethasone nasal spray was evident by the first day of combined treatment and continued throughout the 2-week treatment period. Ipratropium bromide nasal spray had a faster onset of action during the fi rst week of treatment and reduced the duration of rhinorrhea more than becl omethasone. Beclomethasone nasal spray was more effective in reducing the s everity of congestion and sneezing than ipratropium. Tn patients who had no t responded well to a nasal steroid prior to participation in the study bas ed on a questionnaire administered at screening, ipratropium bromide was as effective in the steroid non-responders as steroid responders, whereas bec lomethasone was more effective in steroid responders. Combined active thera py was well tolerated with no increase in adverse events over that seen pre viously with ipratropium bromide or beclomethasone nasal spray alone. Conclusions: The combined use of ipratropium bromide nasal spray with beclo methasone dipropionate nasal spray is more effective than either active age nt for treatment of rhinorrhea, and does not result in a potentiation of ad verse drug reactions. Ipratropium bromide nasal spray 0.03% alone should be considered in patients for whom rhinorrhea is the primary symptom, and its use in combination with a nasal steroid should be considered in patients w here rhinorrhea is one of the predominant symptoms, or in patients with rhi norrhea not fully responsive to other therapy.