Flovent - Clinical Pharmacology

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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.

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.

Figure 1 displays results of pulmonary function tests for the recommended starting dosage of FLOVENT Inhalation Aerosol (88 mcg twice daily) and placebo from a 12-week trial in patients with asthma inadequately controlled on bronchodilators alone. Because this trial used predetermined criteria for lack of efficacy, which caused more patients in the placebo group to be withdrawn, pulmonary function results at Endpoint, which is the last evaluable FEV1 result and includes most patients' lung function data, are also provided.

Pulmonary function improved significantly with FLOVENT Inhalation Aerosol compared with placebo by the second week of treatment, and this improvement was maintained over the duration of the trial.

Figure 1. A 12-Week Clinical Trial in Patients Inadequately Controlled on Bronchodilators Alone: Mean Percent Change

From Baseline in FEV1 Prior to AM Dose