Fluticasone furoate and vilanterol trifenatate

(Breo Ellipta®)

Breo Ellipta®

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Drug updated on 4/24/2024

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 long-acting beta2-adrenergic agonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

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

Summary
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  • Fluticasone furoate and vilanterol trifenatate (Breo Ellipta) is recommended for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) and asthma in individuals aged 5 years and older. It has demonstrated significant improvements in lung function, as measured by Forced Expiratory Volume in one second (FEV1), compared to placebo.
  • Two studies were analyzed that focused on the efficacy of Breo Ellipta in treating COPD and asthma. One was based on nine clinical studies that included 3,896 asthma patients comparing responses to treatment with placebo, dual combination therapy, and triple combination therapy over up to one year.
  • Regarding safety considerations among different population types or subgroups, race was identified as a significant baseline covariate but did not affect FEV1 trajectory parameters according to the analysis focusing on Asthma Treatment.
  • Another study provided a network meta-analysis on the efficacy of single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus other combinations therapies in treating COPD. This study involved adults aged at least 40 years, indicating the drug's suitability for this age group.
  • Compared to other therapies for managing COPD symptoms, such as exacerbation rates or quality-of-life measures like St George's Respiratory Questionnaire scores, FF/UMEC/VI significantly increased trough FEV1 more effectively than all compared triple therapy combinations except UMEC+FF/VI over a primary endpoint period of 24 weeks.
  • Overall, these studies emphasize Breo Ellipta's comparative advantage against other treatments currently available, while also suggesting potential considerations for subgroups such as age and race, which might require further investigation.