Fluticasone furoate and vilanterol

(Breo Ellipta®)

Breo Ellipta®

Drug updated on 11/1/2024

Dosage FormPowder (oral inhalation; 50 mcg fluticasone furoate and 25 mcg vilanterol per actuation, 100 mcg fluticasone furoate and 25 mcg vilanterol per actuation, 200 mcg fluticasone furoate and 25 mcg vilanterol per actuation)
Drug ClassCorticosteroids and beta-2 adrenergic agonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
  • Indicated for the maintenance treatment of asthma in patients aged 5 years and older.

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Summary
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  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) demonstrated statistically significant improvements in trough Forced Expiratory Volume (FEV1) at 24 weeks compared to all other triple therapy comparators, except for umeclidinium combined with fluticasone and vilanterol (UMEC + FF/VI).
  • At 24 weeks, FF/UMEC/VI showed statistically significant reductions in the annualized rate of combined moderate or severe exacerbations compared to single-inhaler budesonide/glycopyrronium bromide/formoterol (BUD/GLY/FOR) and UMEC + FF/VI.
  • FF/UMEC/VI also exhibited improvements in mean St. George's Respiratory Questionnaire (SGRQ) scores and a significant reduction in rescue medication use compared to BUD/GLY/FOR at 24 weeks.
  • The studies did not provide detailed information on specific safety outcomes or adverse effects related to fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI).
  • No significant safety concerns or adverse effects were reported for FF/UMEC/VI, budesonide/glycopyrronium bromide/formoterol (BUD/GLY/FOR), or budesonide/glycopyronium/formoterol fumarate metered dose inhaler (BGF MDI).
  • The studies focused on adults aged at least 40 years with moderate to very severe chronic obstructive pulmonary disease (COPD), but no specific findings relevant to particular subgroups, such as age groups, gender, or comorbid conditions, were detailed.

Product Monograph / Prescribing Information

Document TitleYearSource
Breo Ellipta (fluticasone furoate and vilanterol) Prescribing Information.2023GlaxoSmithKline, Philadelphia, PA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines