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 spray. Studies have shown that about 64% (256 micrograms) of a nominal dose of 400 micrograms budesonide pMDI preparation is delivered to the patient compared with 100% of the nominal dose of the pump spray. The present study was undertaken to assess the efficacy and safety of budesonide delivered via a nasal pMDI twice daily (Rhinocort pMDI, at 400 micrograms/day) with an aqueous suspension of budesonide delivered via a metered nasal pump spray once daily (Rhinocort Aqua, at 256 micrograms/day or 400 micrograms/day). The multicenter, double-blind, randomized, placebo-controlled, parallel-group study was conducted in 318 patients (154 men, 164 women; aged 12-67 years) with ragweed-induced seasonal allergic rhinitis. A 1-week baseline period was followed by a 3-week treatment. Nasal symptoms were recorded by the patients, adverse events were noted, an overall evaluation of treatment efficacy was made, and urine cortisol and creatinine levels were measured. Substantial or total control of symptoms was achieved in 83.8% of patients treated with 256 micrograms of aqueous budesonide, 76.3% with 400 micrograms of aqueous budesonide, and 80.8% with 400 micrograms of budesonide pMDI; these were all significantly different (p < 0.001) compared with placebo (23.4% of patients). There were no significant 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. It was concluded that budesonide, given once daily as 256 micrograms or 400 micrograms in an aqueous suspension or twice daily as 400 micrograms in a pMDI provides good alleviation of the symptoms of seasonal allergic rhinitis with no significant risk of suppression of urine cortisol.
Day
J
J
Department of Medicine, Queen's University, Kingston, Ontario, Canada.
Alexander
M
M
Drouin
M
M
Frankish
C
C
Mazza
J
J
Moote
W
W
Patel
P
P
Ramsdale
H
H
Yang
W
W
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000336:Aerosols; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019819:Budesonide; D002648:Child; D003404:Creatinine / Q000652:urine; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000652:urine; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D009666:Nose / Q000473:pathology / Q000503:physiopathology; D010349:Patient Compliance; D010919:Placebos; D011282:Pregnenediones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D012449:Safety; D016896:Treatment Outcome
D000336:Aerosols; D000893:Anti-Inflammatory Agents; D010919:Placebos; D011282:Pregnenediones; D019819:Budesonide; D003404:Creatinine; D006854:Hydrocortisone