IPRATROPIUM NASAL SPRAY IN CHILDREN WITH PERENNIAL RHINITIS

Objective: To compare the efficacy and safety of ipratropium nasal spr ay and placebo administered twice each day for 4 weeks in pediatric pa tients with perennial rhinitis who had rhinorrhea as a major complaint . Methods: This was a multicenter, double-blind, parallel group study. Patients aged 6 to 18 years with symptoms of perennial nonallergic (P NAR) or perennial allergic rhinitis (PAR) were randomized to receive i pratropium (42 mu g per nostril) or placebo nasal spray, double-blind, twice each day for 4 weeks. Efficacy was evaluated by nasal symptoms, especially anterior rhinorrhea, and quality of life. Previous caregiv ers for rhinitis and medications used in the past were also evaluated. Results: A total of 202 patients were empanelled, 162 with PAR, 40 wi th PNAR; of these 151 with mild-severe rhinorrhea were evaluated for e fficacy. Treatment with ipratropium reduced symptoms of rhinorrhea pri marily in patients with PNAR. In patients with PAR this response was l ess pronounced, and was seen as a modest decrease in the severity of r hinorrhea noted in the first 2 weeks of treatment. Quality of life ass essments confirmed that rhinorrhea was bothersome to these pediatric p atients, and suggested that treatment with ipratropium nasal spray was associated with an improvement, especially in the patients with PNAR. There were few adverse events; these were similar in the two treatmen t groups. Conclusions: Ipratropium nasal spray 0.03% administered at a dose of 42 mu g/nostril bid is a safe and effective new therapy for c ontrol of anterior rhinorrhea in pediatric patients with PNAR. Twice d aily administration is adequate for patients with PNAR, but patients w ith PAR might benefit from more frequent administration (eg, rid).