Drug updated on 7/25/2024
Dosage Form | Powder (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 Class | Corticosteroids and long-acting beta2-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
- Fluticasone furoate and vilanterol trifenatate (Breo Ellipta) are used for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) and asthma in patients aged 5 years and older.
- Reviewed a total of 2 studies from systematic reviews/meta-analyses.
- In adults with asthma, both dual therapy (fluticasone furoate/vilanterol) and triple therapy significantly improved trough FEV1 compared to placebo, showing clinically meaningful improvements. Race was found to be significant in affecting baseline FEV1 but not the trajectory of response over time.
- For COPD, fluticasone furoate/umeclidinium/vilanterol showed significant increases in trough FEV1 more than all other triple comparators except UMEC + FF/VI. It also significantly lowered annualized rates of moderate or severe exacerbations compared to single-inhaler budesonide/glycopyrronium bromide/formoterol fumarate (BUD/GLY/FOR).
- Significant improvements were observed in St. George's Respiratory Questionnaire scores at 24 weeks for COPD patients using fluticasone furoate/umeclidinium/vilanterol versus other therapies, along with reduced rescue medication use compared to BUD/GLY/FOR.
- Breo Ellipta demonstrates substantial efficacy for both asthma and COPD treatments by improving lung function metrics like FEV1, reducing exacerbation rates, enhancing quality-of-life scores such as SGRQ, while subgroup analysis indicates consistent effectiveness across different racial groups despite differences at baseline lung function levels.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Breo Ellipta (fluticasone furoate and vilanterol trifenatate) Prescribing Information. | 2023 | GlaxoSmithKline, Durham, NC |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Longitudinal Model-Based Meta-Analysis of Lung Function Response to Support Phase III Study Design in Chinese Patients With Asthma. | 2022 | Clinical Pharmacology and Therapeutics |
Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Triple Therapy Compared with Other Therapies for the Treatment of COPD: A Network Meta-Analysis. | 2022 | Advances in Therapy |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
2023 Canadian Thoracic Society Guideline on Pharmacotherapy in Patients with Stable COPD. | 2023 | Canadian Journal of Respiratory, Critical Care, and Sleep Medicine |
Inhaled corticosteroid doses for NICE’s asthma guideline | 2023 | NICE |
ICS/Ultra LABA in the Treatment of Obstructive Airway Diseases: A Consensus of Indian Experts. | 2022 | Advances in respiratory medicine |
Spanish COPD guidelines (GesEPOC) 2021: Updated pharmacological treatment of stable COPD. | 2021 | Archivos de Bronconeumologia |
2020 Gold pocket guide to COPD diagnosis, management, and prevention. | 2020 | Global Initiative for Chronic Obstructive Lung Disease |
COPD-X Concise Guide. | 2020 | Lung Foundation Australia |
Canadian Thoracic Society Clinical Practice Guideline on pharmacotherapy in patients with COPD – 2019 update of evidence | 2019 | Canadian Journal of Respiratory, Critical Care, and Sleep Medicine |