Flonase Clinical Trials and Studies

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Flonase Clinical Trials and Studies

A total of 13, randomized, double-blind, parallel, multicenter, vehicle-controlled clinical Flonase trials were conducted in the United States in adults and pediatric patients (4 years of age and older) with seasonal of perennial allergic rhinitis. The Flonase trials included 2633 adults (1439 men and 1194 women) with mean age of 37 years (range, 18 to 79). A total of 440 adolescents (405 boys and 35 girls), mean age of 14 (range, 12 to 17), and 500 children (325 boys and 175 girls), mean age of 9 (range, 4 to 11) were also studied. The overall racial distribution was 89% white, 4% black, and 7% other. These trials evaluated the total nasal symptoms scores (TNSS) that included rhinorrhea, nasal obstruction, sneezing, and nasal itching in known allergic patients who were treated for 2 to 24 weeks. Subjects treated with fluticasone propionate nasal spray exhibited significantly greater decreases in TNSS than vehicle Flonase (placebo-treated) patients. Nasal mucosal basophils and eosinophils were also reduced at the end of treatment in adult studies; however, the clinical significance of this decrease is not known.

There were no significant differences between fluticasone propionate regimens whether administered as a single daily dose of 200 mcg (two 50-mcg sprays in each nostril) or as 100 mcg (one 50-mcg spray in each nostril) twice daily in six clinical trials. A clear dose response could not be identified in clinical trials. In one trial, 200 mcg/day was slightly more effective than 50 mcg/day during the first few days of Flonase treatment, thereafter, no difference was seen.

Three randomized, double-blind, parallel, vehicle-controlled Flonase trials were conducted in 1191 patients with perennial nonallergic rhinitis. These trials evaluated the patient-rated total nasal symptom scores (nasal obstruction, postnasal drip, rhinorrhea) in patients treated for 28 days of double-blind therapy and in one of the three trials for 6 months of open-label treatment. Two of these trials demonstrated that patients treated with Flonase (fluticasone propionate) nasal spray at a dose of 100 mcg twice daily exhibited statistically significant decreases in total nasal symptom scores compared with patients treated with vehicle.

Flonase Information