Multicentric study of beclomethasone dipropionate nasal aerosol in adults with seasonal allergic rhinitis.
A double-blind, parallel-design multicentric study, in two phases, was conducted to examine the safety and efficacy of 2-wk treatment with various doses of beclomethasone dipropionate nasal aerosol (BDNA) and placebo in adults with seasonal allergic rhinitis. In phase I, 162 patients received BDNA, 33.5 micrograms/burst (o.d.,b.i.d., t.i.d., q.i.d.), or placebo; in phase II, 189 patients received BNDA 42, micrograms/burst (b.i.d. q.i.d.), or placebo. In both phases, statistically significant (p less than 0.05) differences favoring BDNA over placebo were found for all efficacy measures (global evaluation and total and individual symptom scores). In phase I, response to treatment increased as BDNA dosage increased, with a leveling off at t.i.d. dosage. In both phases, marked improvements were seen by week 1, with maximum improvement during week 2. Eighty-seven patients had adverse reactions-sneezing and nasal burning were most common. No suppression in morning cortisol levels was seen, nor were Candida infections promoted. A 2-wk treatment with BDNA was safe and effective in the treatment of seasonal allergic rhinitis in adults.
D000328:Adult; D000336:Aerosols; D001507:Beclomethasone / Q000008:administration & dosage* / Q000627:therapeutic use; D002175:Candida / Q000302:isolation & purification; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D008875:Middle Aged; D009297:Nasal Mucosa / Q000382:microbiology; D010614:Pharynx / Q000382:microbiology; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*
D000336:Aerosols; D001507:Beclomethasone; D006854:Hydrocortisone