LYCOS RETRIEVER 
Advair Diskus: Asthma
built 635 days ago
Due to an isolated manufacturing issue, a small number of Glaxo SmithKline's (GSK) Advair 'Diskus' 100/50 mcg 60 dose dry powder inhalers have a defect that in some circumstances could mean that a patient would not receive their asthma maintenance medicine. As a result, GSK is contacting health care professionals as well as pharmacies and wholesalers to help ensure that potentially affected products are returned and replaced. Patients should not discontinue use of Advair, but should check the lot numbers and get replacements of any products in these particular lots. Other strengths or pack sizes of Advair Diskus are not affected, and products outside the US are not affected.
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Advair Diskus can be used both in adults and in children age 4 years and older. It is most commonly used in people who have not been able to achieve adequate asthma control with only an inhaled steroid.
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In a 12-week US study, ADVAIR DISKUS 100/50 twice daily was compared with fluticasone propionate inhalation powder 100 mcg twice daily in 203 children with asthma aged 4 to 11 years. At study entry, the children were symptomatic on low doses of inhaled corticosteroids (beclomethasone dipropionate 252 to 336 mcg/day; budesonide 200 to 400 mcg/day; flunisolide 1,000 mcg/day; triamcinolone acetonide 600 to 1,000 mcg/day; or fluticasone propionate 88 to 250 mcg/day). The primary objective of this study was to determine the safety of ADVAIR DISKUS 100/50 compared with fluticasone propionate inhalation powder 100 mcg in this age-group; ... the study also included secondary efficacy measures of pulmonary function. Morning predose FEV 1 was obtained at baseline and Endpoint (last available FEV 1 result) in children aged 6 to 11 years. In patients receiving ADVAIR DISKUS 100/50, FEV 1 increased from 1.70 L at baseline (N = 79) to 1.88 L at Endpoint (N = 69) compared with an increase from 1.65 L at baseline (N = 83) to 1.77 L at Endpoint (N = 75) in patients receiving fluticasone propionate 100 mcg.The findings of this study, along with extrapolation of efficacy data from patients 12 years of age and older, support the overall conclusion that ADVAIR DISKUS 100/50 is efficacious in the maintenance treatment of asthma in patients aged 4 to 11 years.
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Although approved for children over age 4, some children under age 5 or 6 have a hard time using the breath-activated Advair Diskus. Alternative asthma controllers might include Pulmicort Respules, that can be given with a nebulizer, or using a Flovent MDI with a spacer and mask.
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The study ... found significantly greater improvements in morning peak expiratory flow (PEF), a standard measure of lung function, with Advair Diskus 100/50 compared with Singulair 10 mg in patients with milder asthma as well as those with more moderate asthma. Patients with forced expiratory volume in one second (FEV[1]) greater than or equal to 70 percent of predicted normal at study entry were considered to have milder asthma, while those with an FEV(1) of less than 70 percent of predicted normal at study entry were considered to have more moderate asthma.
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Long-acting beta2-adrenergic agonists, such as salmeterol, one of the active ingredients in ADVAIR DISKUS, may increase the risk of asthma-related death. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies. Data from a large placebo-controlled US study that compared the safety of salmeterol (SEREVENT® Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 patients on placebo) (see WARNINGS).
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