BUDESONIDE AQUEOUS NASAL SPRAY AND PRESSURIZED METERED-DOSE INHALER IN THE TREATMENT OF ADULT PATIENTS WITH SEASONAL ALLERGIC RHINITIS

Budesonide, a topical corticosteroid used in the treatment of seasonal allergic rhinitis, can be administered to the nose as an aerosol via a pressurized metered dose inhaler (pMDI) or as a metered nasal pump s pray. Studies have shown that about 64% (256 mu g) of a nominal dose o f 400 mu g budesonide pMDI preparation is delivered to the patient com pared with 100% of the nominal dose of the pump spray. The present stu dy was undertaken to assess the efficacy and safety of budesonide deli vered via a nasal pMDI twice daily (Rhinocort(R) pMDI, at 400 mu g/day ) with an aqueous suspension of budesonide delivered via a metered nas al pump spray once daily (Rhinocort(R) Aqua, at 256 mu g/day or 400 mu g/day). The multicenter, double-blind, randomized, placebo-controlled , parallel-group study was conducted in 318 patients (154 men, 164 wom en; aged 12-67 years) with ragweed-induced seasonal allergic rhinitis. A 1-week baseline period was followed by a 3-week treatment. Nasal sy mptoms were recorded by the patients, adverse events were noted, an ov erall evaluation of treatment efficacy was made, and urine cortisol an d creatinine levels were measured Substantial or total control of symp toms was achieved in 83.8% of patients treated with 256 mu g of aqueou s budesonide, 76.3% with 400 mu g of aqueous budesonide, and 80.8% wit h 400 mu g of budesonide pMDI; these were all significantly different (p <0.001) compared with placebo (23.4% of patients). There were no si gnificant differences in the 24-hour urine cortisol levels between the groups and there were few, infrequent adverse events, similar between the groups and resolved completely on discontinuation of treatment. I t was concluded that budesonide, given once daily as 256 mu g or 400 m u g in an aqueous suspension or twice daily as 400 mu g in a pMDI prov ides good alleviation of the symptoms of seasonal allergic rhinitis wi th no significant risk of suppression of urine cortisol.