Background: Fluticasone furoate is a once-daily inhaled corticosteroid. This report provides an overview of safety\nand efficacy data that support the use of once-daily fluticasone furoate 100 �¼g or 200 �¼g in adult and adolescent\nasthma patients.\nMethods: Fourteen clinical studies (six Phase II and eight Phase III) were conducted as part of the fluticasone furoate\nglobal clinical development programme in asthma. Safety data from 10 parallel-group, randomised, double-blind Phase\nII and III studies (including 3345 patients who received at least one dose of fluticasone furoate) were integrated to\nprovide information on adverse events, withdrawals, laboratory assessments, vital signs and hypothalamic-pituitaryadrenal\naxis function. The efficacy of once-daily fluticasone furoate was evaluated in all included studies.\nResults: Once-daily fluticasone furoate 100 �¼g and 200 �¼g safety profiles were consistent with those reported for other\ninhaled corticosteroids, and both doses consistently demonstrated efficacy versus placebo. In the integrated analysis,\nno dose-response relationship was observed for the overall incidence of adverse events and there were no significant\neffects of fluticasone furoate on hypothalamic-pituitary-adrenal axis function.\nConclusion: Once-daily fluticasone furoate 100 �¼g and 200 �¼g had acceptable safety profiles and was efficacious in\nadult and adolescent patients with asthma. There was no evidence of cortisol suppression at studied doses.
Loading....