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The potential systemic effects of inhaled fluticasone propionate on the
hypothalamic-pituitary-adrenal (HPA) axis were also studied in patients with asthma. Fluticasone propionate given by inhalation aerosol at doses of 220, 440, 660, or 880 mcg twice daily was compared with placebo or oral prednisone 10 mg given once daily for 4 weeks. For most patients, the ability to increase cortisol production in response to stress, as assessed by 6-hour cosyntropin stimulation, remained intact with inhaled fluticasone propionate treatment. No patient had an abnormal response (peak less than 18 mcg/ dL) after dosing with placebo or 220 mcg twice daily. Ten percent (10%) to 16% of patients treated with fluticasone propionate at doses of 440 mcg or more twice daily had an abnormal response as compared to 29% of patients treated with prednisone. CLINICAL TRIALS Double-blind, parallel-group, placebo-controlled, US clinical trials were conducted in 1,818 adolescent and adult patients with asthma to assess the efficacy and/ or safety of FLOVENT Inhalation Aerosol in the treatment of asthma. Fixed doses ranging from 22 to 880 mcg twice daily were compared to placebo to provide information about appropriate dosing to cover a range of asthma severity. Patients with asthma included in these studies were those not adequately controlled with beta-agonists alone, those already maintained on daily inhaled corticosteroids, and those requiring oral corticosteroid therapy. Text Continues Below
In all efficacy trials, at all doses, measures of pulmonary function (forced expiratory volume in 1 second [FEV1] and morning peak expiratory flow [AM PEF]) were statistically significantly improved as compared with placebo. In 2 clinical trials of 660 patients with asthma inadequately controlled on bronchodilators alone, FLOVENT Inhalation Aerosol was evaluated at doses of 44 and 88 mcg twice daily. Both doses of FLOVENT Inhalation Aerosol improved asthma control significantly as compared with placebo. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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