ICS/LABA did not show a significantly increased risk of a serious asthma-related event compared with ICS based on the pre-specified risk margin (2.7), with an estimated hazard ratio of time to first event of 1.29 (95% CI: 0.73, 2.27).Salmeterol Multicenter Asthma Research Trial (SMART)A 28-week, placebo-controlled, U.S. trial that compared the safety of salmeterol with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in subjects receiving salmeterol (13/13,176 in subjects treated with salmeterol versus 3/13,179 in subjects treated with placebo; relative risk: 4.37 [95% CI: 1.25, 15.34]). There were 3 cases of nonsustained ventricular tachycardia (1 each in the placebo, salmeterol, and fluticasone propionate 500-mcg treatment groups).In 24-week clinical trials in subjects with COPD, the incidence of clinically significant ECG abnormalities (myocardial ischemia, ventricular hypertrophy, clinically significant conduction abnormalities, clinically significant arrhythmias) was lower for subjects who received salmeterol (1%, 9 of 688 subjects who received either salmeterol 50 mcg or Advair Diskus) compared with placebo (3%, 10 of 370 subjects).No significant differences with salmeterol 50 mcg alone or in combination with fluticasone propionate as Advair Diskus 500/50 were observed on pulse rate and systolic and diastolic blood pressure in a subset of subjects with COPD who underwent 12-hour serial vital sign measurements after the first dose (n = 183) and after 12 weeks of therapy (n = 149). Absolute bioavailability of fluticasone propionate was 5.3% and 5.5% following administration of ADVAIR HFA and Advair Diskus, respectively.Full pharmacokinetic profiles were obtained from 9 female and 16 male subjects with asthma given fluticasone propionate inhalation powder 500 mcg twice daily using the DISKUS inhaler and from 14 female and 43 male subjects with COPD given 250 or 500 mcg twice daily. For all uses of this medicine (Advair Diskus):
In vitro studies show salmeterol to be at least 50 times more selective for betaIn vitro tests show that salmeterol is a potent and long-lasting inhibitor of the release of mast cell mediators, such as histamine, leukotrienes, and prostaglandin DIn a 12-week trial in adult and adolescent subjects with asthma, Advair Diskus 250/50 twice daily was compared with fluticasone propionate inhalation powder 250 mcg alone, salmeterol inhalation powder 50 mcg alone, and placebo.
The mean age of the subjects was 64, and the majority (93%) was Caucasian. Keep using this medicine (Advair Diskus) as you have been told by your doctor or other health care provider, even if you feel well. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0697-00). The subjects had a mean pre-bronchodilator FEVImprovements in lung function (as defined by predose and postdose FEVFigures 4 and 5 display predose and 2-hour postdose, respectively, FEVThe third trial was a 1-year trial that evaluated Advair Diskus 500/50, fluticasone propionate 500 mcg, salmeterol 50 mcg, and placebo in 1,465 subjects. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, If significant reductions in BMD are seen and Advair Diskus is still considered medically important for that patient’s COPD therapy, use of medicine to treat or prevent osteoporosis should be strongly considered.A 2-year trial in 160 subjects (females aged 18 to 40 years, males 18 to 50) with asthma receiving chlorofluorocarbon (CFC)-propelled fluticasone propionate inhalation aerosol 88 or 440 mcg twice daily demonstrated no statistically significant changes in BMD at any time point (24, 52, 76, and 104 weeks of double-blind treatment) as assessed by dual-energy x-ray absorptiometry at lumbar regions L1 through L4.Effects of treatment with Advair Diskus 250/50 or salmeterol 50 mcg on BMD at the LIn this trial there were 7 non-traumatic fractures reported in 5 subjects treated with Advair Diskus and 1 non-traumatic fracture in 1 subject treated with salmeterol.
• thrush in your mouth or throat. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.
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