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| |  AAAAI: Budesonide Aqueous Nasal Spray Relieves Symptoms of Chronic Rhinosinusitis By Jill Stein Special to DG News NEW YORK, NY -- March 5, 2002 -- Budesonide aqueous nasal spray appears to be as effective as monotherapy in the treatment of stable adult chronic rhinosinusitis. Researchers presented the findings here today at the 58th Annual Meeting of the American Academy of Allergy, Asthma, and Immunology (AAAAI). Budesonide is associated with significant benefits in terms of symptoms, peak nasal inspiratory flow (PNIF), and health-related quality of life compared with placebo, according to Dr. Valerie J. Lund with the Royal National Throat, Nose, and Ear Hospital in London, England. Budesonide aqueous nasal spray is a topical formulation of the anti-inflammatory corticosteroid budesonide, which has been shown to be effective in the treatment of seasonal and perennial allergic rhinitis and nasal polyposis. The researchers enrolled 167 adults and randomized them to 20 weeks of treatment with budesonide nasal spray 64 ug per nostril, twice daily or placebo. All participants in the trial had chronic rhinosinusitis symptoms that were stable enough not to require antibiotics. Antibiotic therapy was administered during the first two weeks of the three-week run-in period. Additional antibiotic therapy was given during the treatment period only if exacerbations occurred, as judged by the investigator. Efficacy was determined from combined symptom scores, measurements of individual PNIF, and the health-related quality of life questionnaire SF-36. Budesonide aqueous nasal spray improved combined symptom scores significantly more than placebo (morning reduction of 1.85 versus 1.02; evening reduction of 1.78 versus 1.02). During the study, PNIF increased by a mean of 49.1 L/min in the budesonide group compared with 10.4 L/min in the placebo group. There was a documented significant improvement in the general health domain of the health related quality of life questionnaire in budesonide -treated patients compared with the placebo group. There were no significant differences between groups in the number of exacerbations, the mean time to first exacerbation, or the proportion of antibiotic-free days. Overall, 169 adverse events were reported by 85 patients (treatment: 39, placebo: 46). There were only minor differences in adverse event profiles between the two groups. Also, most adverse events were mild or moderate in severity, and there was no increase in the rate of infection or mucopurulent secretions in patients treated with budesonide aqueous nasal spray. The study was funded by AstraZeneca Lund, in Lund, Sweden.
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