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The effects of RHINOCORT AQUA Nasal Spray on adrenal function have been evaluated in several clinical trials. In a four-week clinical trial, 61 adult patients who received 256 mcg daily of RHINOCORT AQUA Nasal Spray demonstrated no significant differences from patients receiving placebo in plasma cortisol levels measured before and 60 minutes after 0.25 mg intramuscular cosyntropin. There were no consistent differences in
24-hour urinary cortisol measurements in patients receiving up to 400 mcg daily. Similar results were seen in a study of 150 children and adolescents aged 6 to 17 with perennial rhinitis who were treated with 256 mcg daily for up to 12 months. After treatment with the recommended maximal daily dose of RHINOCORT AQUA (256 mcg) for seven days, there was a small, but statistically signif-icant decrease in the area under the plasma cortisol-time curve over 24 hours (AUC 0-24h ) in healthy adult volunteers. A dose-related suppression of 24-hour urinary cortisol excretion was observed after administration of RHINOCORT AQUA doses ranging from 100Ð 800 mcg daily for up to four days in 78 healthy adult volunteers. The clinical relevance of these results is unknown. Text Continues Below
Clinical Trials The therapeutic efficacy of RHINOCORT AQUA Nasal Spray has been eval-uated in placebo-controlled clinical trials of seasonal and perennial allergic rhinitis of 3Ð 6 weeks duration. The number of patients treated with budesonide in these studies was 90 males and 51 females aged 6Ð 12 years and 691 males and 694 females 12 years and above. The patients were predominantly Caucasian.
Overall, the results of these clinical trials showed that RHINOCORT AQUA Nasal Spray administered once daily provides statistically significant reduction in the severity of nasal symptoms of seasonal and perennial allergic rhinitis including runny nose, sneezing, and nasal congestion. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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