Flovent Clinical Pharmacology

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Flovent - Clinical Pharmacology [Fluticasone Propionate]

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this trial used predetermined criteria for lack of efficacy, which caused more patients in the placebo group to be withdrawn, pulmonary function results at Endpoint, which is the last evaluable FEV1 result and includes most patients' lung function data, are also provided.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

In clinical trials of 924 patients with asthma already receiving daily inhaled corticosteroid therapy (doses of at least 336 mcg/ day of beclomethasone dipropionate) in addition to as-needed albuterol and theophylline (46% of all patients), 22-to 440-mcg twice-daily doses of FLOVENT Inhalation Aerosol were also evaluated. All doses of FLOVENT Inhalation Aerosol were efficacious when compared to placebo on major endpoints including lung function and symptom scores.

Patients treated with FLOVENT Inhalation Aerosol were also less likely to discontinue study participation due to asthma deterioration (as defined by predetermined criteria for lack of efficacy including lung function and patient-recorded variables such as AM PEF, albuterol use, and nighttime awakenings due to asthma). Figure 2 displays results of pulmonary function from a 12-week clinical trial in patients with asthma already receiving daily inhaled corticosteroid therapy (beclomethasone dipropionate 336 to 672 mcg/ day). The mean percent change from baseline in lung function results for FLOVENT Inhalation Aerosol dosages of 88, 220, and 440 mcg twice daily and placebo are shown over the 12-week trial. Because this trial also used predetermined criteria for lack of efficacy, which caused more patients in the placebo group to be withdrawn, pulmonary function results at Endpoint are included.