Drug updated on 12/11/2024
Dosage Form | Powder (oral inhalation; fluticasone furoate/ umeclidinium/ vilanterol; 100/62.5/25 mcg, 200/62.5/25 mcg) |
Drug Class | Corticosteroids, anticholinergics 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 18 years and older.
Latest News
Summary
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) (Trelegy Ellipta) significantly increased trough forced expiratory volume in 1 second (FEV₁) at 24 weeks compared to other triple therapy options, except UMEC + FF/VI, in adults aged ≥40 years with moderate to very severe COPD.
- FF/UMEC/VI showed statistically significant reductions in the annualized rate of combined moderate or severe exacerbations versus budesonide/glycopyrronium bromide/formoterol fumarate (BUD/GLY/FOR) and UMEC + FF/VI, as well as improvements in St George’s Respiratory Questionnaire (SGRQ) scores and reductions in rescue medication use over 24 weeks.
- BUD/GLY/FOR and BGF MDI demonstrated comparable efficacy to FF/UMEC/VI in improving lung function, reducing exacerbation rates, and enhancing health-related quality of life at both 24 and 52 weeks.
- The safety profile of FF/UMEC/VI was not detailed in the reviewed studies.
- BUD/GLY/FOR and budesonide/glycopyrronium/formoterol fumarate metered dose inhaler (BGF MDI) were found to have a safety and tolerability profile comparable to other inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2-agonist (ICS/LAMA/LABA) fixed-dose and open combination therapies, with no statistically significant differences in safety outcomes for BGF MDI.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Trelegy Ellipta (fluticasone furoate, umeclidinium, vilanterol) Prescribing Information. | 2023 | GlaxoSmithKline, Philadelphia, PA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Clinical Concepts for Triple Therapy Use in Patients with COPD: A Delphi Consensus | 2023 | International Journal of Chronic Obstructive Pulmonary Disease |
Global strategy for asthma management and prevention (2022 update) | 2022 | Global Initiative for Asthma |
Asthma guideline updates. | 2022 | ACSAP: Pulmonary Care |
A Delphi Consensus Document on the Use of Single-Inhaler Fixed-Dose Triple Therapies in COPD Patients | 2020 | International Journal of Chronic Obstructive Pulmonary Disease |