Efficacy and tolerability of budesonide aqueous nasal spray treatment in patients with nasal polyps

Objective: To assess the efficacy and tolerability of once-daily treatment with budesonide aqueous nasal spray in patients with nasal polyps. Design: Randomized, double-blind, placebo-controlled, parallel-group study. Setting: Sixteen hospital clinics. Patients: One hundred eighty-three patients with moderate-sized nasal polyp s causing clinically significant symptoms during a 1-week run-in period. Interventions: Patients were randomized to receive 1 of the following 4 bud esonide aqueous nasal spray treatments: 128 mug once daily in the morning a nd placebo in the evening, 128 mug twice daily, 256 mug once daily in the m orning and placebo in the evening, or placebo for 8 weeks. Nasal polyp size was scored and peak nasal inspiratory flow was measured at clinic visits a t the beginning and end of the run-in period and after 4 and 8 weeks' treat ment. Patients recorded daily peak nasal inspiratory flow, symptom scores t ie, blocked nose, runny nose, and sneezing) and sense of smell on diary car ds. Main Outcome Measures: Mean change in nasal polyp size at the end of treatm ent; mean changes in combined and individual symptom scores. Results: All doses of budesonide aqueous nasal spray significantly (P<.01) reduced polyp size; no significant differences were noted between the 4 tre atment groups. The mean improvement in clinic peak nasal inspiratory flow a t 8 weeks was 65.9 L/min with budesonide aqueous nasal spray, 128 <mu>g twi ce daily; 71.6 L/min with budesonide aqueous nasal spray, 256 mug once dail y; and 54.6 L/min with budesonide aqueous nasal spray, 128 mug once daily t all P<.001 vs placebo). Combined and individual symptom scores and sense of smell improved significantly in all budesonide-treated groups; the effect on symptoms became apparent within 1 to 2 days of the first dose. Budesonid e aqueous nasal spray was well tolerated. Conclusions: Doses of budesonide aqueous nasal spray, 128 <mu>g once daily, were found to be effective in the treatment of nasal polyps, and doses of budesonide aqueous nasal spray, 256 mug once daily, did not show any signif icant additional efficacy.