Trial 3 was a 24-week trial that evaluated the efficacy of BREO ELLIPTA 200/25 once daily, fluticasone furoate 200 mcg once daily, and fluticasone propionate 500 mcg twice daily in adult and adolescent subjects with asthma. [see Use in Specific Populations ( Increasing use of inhaled, short-acting beta

A randomized, double-blind, multicenter, multinational trial prospectively evaluated the efficacy of BREO ELLIPTA 100/25 compared with placebo on survival. Consult drug interactions database for more detailed information.• Pediatric: Data from controlled clinical trials suggest LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Monitor lung function, beta-agonist use, asthma and COPD symptoms, and for signs and symptoms of adrenal insufficiency (fatigue, lassitude, weakness, nausea and vomiting, hypotension) during withdrawal. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). This document does not contain all possible drug interactions. Subjects treated with BREO ELLIPTA 100/25 had a lower annual rate of moderate/severe COPD exacerbations compared with vilanterol in both trials ( Fluticasone furoate/vilanterol 200/25 mcg in Asian asthma patients: a randomized trial Respir Med. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non–potassium-sparing diuretics.There are insufficient data on the use of BREO ELLIPTA, fluticasone furoate, or vilanterol in pregnant women. Management: Consider alternatives to this combination when possible. Adjudicated, on-treatment deaths due to pneumonia occurred in 13 subjects receiving BREO ELLIPTA 100/25, 9 subjects receiving placebo, 10 subjects receiving fluticasone furoate 100 mcg, and 6 subjects receiving vilanterol 25 mcg (<0.2 per 100 patient-years for each treatment group).Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects.Fluticasone furoate systemic exposure increased by up to 3-fold in subjects with hepatic impairment compared with healthy subjects. FF is structurally distinct from fluticasone … Avoid exposure in such patients who have not had these diseases or been properly immunized. Subjects receiving BREO ELLIPTA 100/25 (Trial 2) or BREO ELLIPTA 200/25 (Trial 3) had significantly greater improvements from baseline in percentage of 24-hour periods without need of beta If systemic corticosteroid withdrawal effects occur (eg, fatigue, lassitude, weakness, nausea, vomiting, hypotension), taper fluticasone/vilanterol slowly and other treatments for management of COPD symptoms should be considered.• Asthma-related deaths: The use of long-acting beta-2 agonists (LABAs) as monotherapy has been associated with an increased risk of severe exacerbations and asthma-related deaths (SMART 2006; Walters 2007); additional data from other clinical trials suggests risk of asthma-related hospitalization may also be increased with LABA monotherapy in pediatric and adolescent patients. One strip contains fluticasone furoate (100 or 200 mcg per blister), and the other strip contains vilanterol (25 mcg per blister). The increased risk of asthma-related death is considered a class effect of LABA monotherapy.BREO ELLIPTA should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD or asthma.

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