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One patient receiving FLOVENT DISKUS 50 mcg (fluticasone propionate inhalation powder, 50 mcg) FLOVENT DISKUS 100 mcg (fluticasone propionate inhalation powder, 100 mcg) FLOVENT DISKUS 250 mcg (fluticasone propionate inhalation powder, 250 mcg) 5 fluticasone propionate via DISKUS had a prestimulation plasma cortisol concentration < 5 mcg/dL, and 2 patients had a rise in cortisol of < 7 mcg/dL. However, all poststimulation values were >18 mcg/dL. Clinical Trials: Four double-blind, parallel, placebo-controlled, US clinical trials were conducted in 1036 adolescent and adult patients ( 12 years of age) with asthma to assess the efficacy and safety of FLOVENT DISKUS. These studies included fixed doses of 100, 250, and 500 mcg twice daily 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 bronchodilators alone, and those already maintained on daily inhaled corticosteroids. All doses were delivered by inhalation of the contents of 1 or 2 blisters from the DISKUS twice daily. Displayed in the figures below are results of pulmonary function tests (mean percent change from baseline in FEV1 prior to AM dose) for 3 recommended dosages of fluticasone propionate inhalation powder (100, 250, and 500 mcg twice daily) and placebo from the four 12-week trials in adolescents and adults. Because these trials used predetermined criteria for lack of efficacy, which caused more patients in the placebo group to be withdrawn, pulmonary function results at Endpoint, which is the last evaluable FEV1 result and includes most patients’ lung function data, are also provided. Text Continues Below
Pulmonary function at recommended dosages of fluticasone propionate improved significantly compared with placebo by the first week of treatment, and improvement was maintained for up to 1 year or more. Figure 1: A 12-Week Clinical Trial Evaluating FLOVENT DISKUS 100 mcg Twice Daily in Adolescents and Adults Receiving Bronchodilators Alone 6
N/A Figure 2: A 12-Week Clinical Trial Evaluating FLOVENT DISKUS 100 mcg Twice Daily in Adolescents and Adults Receiving Inhaled Corticosteroids FLOVENT DISKUS 50 mcg (fluticasone propionate inhalation powder, 50 mcg) FLOVENT DISKUS 100 mcg (fluticasone propionate inhalation powder, 100 mcg) FLOVENT DISKUS 250 mcg (fluticasone propionate inhalation powder, 250 mcg)
N/A Figure 3: A 12-Week Clinical Trial Evaluating FLOVENT DISKUS 250 mcg Twice Daily in Adolescents and Adults Receiving Inhaled Corticosteroids or Bronchodilators Alone
N/A Figure 4: A 12-Week Clinical Trial Evaluating FLOVENT DISKUS 500 mcg Twice Daily in Adolescents and Adults Receiving Inhaled Corticosteroids or Bronchodilators Alone FLOVENT DISKUS 50 mcg (fluticasone propionate inhalation powder, 50 mcg) FLOVENT DISKUS 100 mcg (fluticasone propionate inhalation powder, 100 mcg) FLOVENT DISKUS 250 mcg (fluticasone propionate inhalation powder, 250 mcg)
N/A In all efficacy trials, measures of pulmonary function (FEV1) and morning peak expiratory flow rate (AM PEFR) were statistically significantly improved as compared with placebo at all twice-daily doses. Patients on all fluticasone propionate dosages were also significantly 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 PEFR, albuterol use and nighttime awakenings due to asthma) compared with placebo. In a clinical trial of 111 patients with severe asthma requiring chronic oral prednisone therapy (average baseline daily prednisone dose was 14 mg), fluticasone propionate given by inhalation powder at doses of 500 and 1000 mcg twice daily was evaluated. Both doses enabled a statistically significantly larger percentage of patients to wean successfully from oral prednisone as compared with placebo (75% of the patients on 500 mcg twice daily and 89% of the patients on 1000 mcg twice daily as compared with 9% of patients on placebo). Accompanying the reduction in oral corticosteroid use, patients treated with fluticasone propionate had significantly improved lung function and fewer asthma symptoms as compared with the placebo group. Pediatric Experience: A 12-week, placebo-controlled clinical trial was conducted in 437 patients (177 on fluticasone propionate via DISKUS) aged 4 to 11 years, approximately half of whom were receiving inhaled corticosteroids at baseline. In this study, doses of fluticasone propionate inhalation powder 50 and 100 mcg twice daily significantly improved FEV1 (15% and 18% change from baseline at Endpoint, respectively) compared to placebo (7% change). Morning peak expiratory flow rate was also significantly improved with doses of fluticasone propionate 50 and 100 mcg twice daily (26% and 27% change from baseline at Endpoint, respectively) compared to placebo (14% change). In this study, patients on active treatment were significantly less likely to discontinue treatment due to asthma deterioration (as defined by predetermined criteria for lack of efficacy including lung function and patient recorded variables such as AM PEFR, albuterol use, and nighttime awakenings due to asthma). Two other 12-week placebo-controlled clinical trials were conducted in 504 pediatric patients with asthma, approximately half of whom were receiving inhaled corticosteroids at baseline. In these studies, fluticasone propionate inhalation powder was efficacious at doses of 50 and 100 mcg twice daily when compared to placebo on major endpoints including lung function and symptom scores. Pulmonary function improved significantly compared with placebo by the first week of treatment, and patients treated with fluticasone propionate were also less likely to discontinue study participation due to asthma deterioration. One hundred ninety-two (192) patients received fluticasone propionate for up to 1 year during an open-label extension. Data from this open-label extension suggested that lung function improvements could be maintained up to 1 year. Page: << Prev | 1 | 2 | 3 | 4 | 5
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