Drug updated on 4/24/2024
| 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
- 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
- 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.
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 |