To assess the efficacy and tolerability of once-daily treatment with budesonide aqueous nasal spray in patients with nasal polyps.
Randomized, double-blind, placebo-controlled, parallel-group study.
Sixteen hospital clinics.
One hundred eighty-three patients with moderate-sized nasal polyps causing clinically significant symptoms during a 1-week run-in period.
Patients were randomized to receive 1 of the following 4 budesonide aqueous nasal spray treatments: 128 µg once daily in the morning and placebo in the evening, 128 µg twice daily, 256 µg once daily in the morning 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 at the beginning and end of the run-in period and after 4 and 8 weeks' treatment. Patients recorded daily peak nasal inspiratory flow, symptom scores (ie, blocked nose, runny nose, and sneezing) and sense of smell on diary cards.
Main Outcome Measures
Mean change in nasal polyp size at the end of treatment; mean changes in combined and individual symptom scores.
All doses of budesonide aqueous nasal spray significantly (P<.01) reduced polyp size; no significant differences were noted between the 4 treatment groups. The mean improvement in clinic peak nasal inspiratory flow at 8 weeks was 65.9 L/min with budesonide aqueous nasal spray, 128 µg twice daily; 71.6 L/min with budesonide aqueous nasal spray, 256 µg once daily; and 54.6 L/min with budesonide aqueous nasal spray, 128 µg once daily (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. Budesonide aqueous nasal spray was well tolerated.
Doses of budesonide aqueous nasal spray, 128 µg once daily, were found to be effective in the treatment of nasal polyps, and doses of budesonide aqueous nasal spray, 256 µg once daily, did not show any significant additional efficacy.