A comparison of aqueous suspensions of budesonide nasal spray (128 micrograms and 256 micrograms once daily) and fluticasone propionate nasal spray (200 micrograms once daily) in the treatment of adult patients with seasonal allergic rhinitis.

Abstract

The efficacy of aqueous suspensions of budesonide nasal spray and fluticasone propionate nasal spray, in the treatment of seasonal allergic rhinitis, was compared in a large, placebo-controlled, two-center study. A 1-week baseline period was followed by a 4- to 6-week treatment period during which 635 adult patients, aged 18-72 years, were randomized to receive either placebo, budesonide 128 micrograms, or 256 micrograms once daily, or fluticasone propionate, 200 micrograms once daily. Nasal and eye symptoms, overall treatment efficacy and safety assessments were made during the study period. Combined, as well as individual, nasal symptoms were significantly improved in all three active treatment groups compared with placebo therapy. Treatment with 256 micrograms/day of budesonide was found to be significantly more effective in reducing the sneezing score compared with 200 micrograms/day of fluticasone propionate. Analysis of symptom scores on days when the pollen count was greater than 10 grains/m3 revealed 256 micrograms/day of budesonide therapy to be significantly more effective in reducing combined symptom scores as well as the individual scores for sneezing and runny nose, compared with 200 micrograms/day fluticasone propionate. The higher dose of budesonide (256 micrograms/day) was also more effective than the lower dose (128 micrograms/day) in reducing sneezing scores and statistical significance was almost reached for the reduction in combined symptom and runny nose scores. Substantial or total control of symptoms was achieved by 31.4%, 85.3%, 88.4%, and 81.9% of patients receiving placebo, 128 micrograms/day of budesonide, 256 micrograms/day of budesonide, and 200 micrograms/day of fluticasone propionate, respectively. The incidence of adverse events was low in all treatment groups. In conclusion, both budesonide and fluticasone propionate treatments were effective and well-tolerated in the treatment of seasonal allergic rhinitis. However, 256 micrograms/day of budesonide tended to be more effective than 200 micrograms/day of fluticasone propionate and 128 micrograms/day of budesonide, especially when patients were exposed to a higher pollen load.