What is Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for?

Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is combined medication that is prescribed for once-daily, long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) and asthma. It is intended for patients with chronic bronchitis and/or emphysema, as well as those who require additional treatment for airflow obstruction while using a fixed-dose combination of fluticasone furoate and vilanterol. Trelegy Ellipta is also suitable for patients who already receive umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol. It is administered using an inhaler which contains two foil strips, each with 30 blisters for powder inhalation. One strip contains 100 or 200 mcg fluticasone furoate per blister, while the other contains a combination of 62.5 mcg umeclidinium and 25 mcg vilanterol per blister. A dose is created using a blister from each strip.

How does Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) work?

Chronic lung diseases such as COPD and asthma can cause inflammation and narrowing of the airways. Trelegy Ellipta is a combination therapy that contains three active ingredients. Fluticasone furoate, a synthetic trifluorinated inhaled corticosteroid (ICS), works as an anti-inflammatory, targeting multiple parts of inflammation related to COPD in the airways. Umeclidinium, also known as a long-acting muscarinic antagonist (LAMA) or anticholinergic, acts as a bronchodilator by relaxing the muscle cells in the lungs to widen the airways, making breathing easier. Vilanterol is a long-acting beta2-adrenergic agonist (LABA) that functions as a bronchodilator by activating beta2 receptors on muscle cells in the lungs, leading to relaxation of airway cells. When combined, these active ingredients provide a more effective symptom reduction for the maintenance therapy of COPD or asthma, improving the quality of life.

How is Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) taken?

According to the reference provided, the standard dose range for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) in the treatment of COPD and asthma is 100 mcg fluticasone furoate, 62.5 mcg umeclidinium, and 25 mcg vilanterol. Additionally, there is a higher strength available for asthma alone, which contains 200 mcg fluticasone furoate, 62.5 mcg umeclidinium, and 25 mcg vilanterol. The medication is administered once daily through oral inhalation at the same time every day and should not be used more frequently than once every 24 hours. Patients are advised to rinse their mouth with water without swallowing after using Trelegy Ellipta to decrease the risk of fungal infections in the nose or mouth. Further details regarding dosage and administration can be found in the official prescribing information listed in the references. Please note that personalized dosing and potential drug interactions should be discussed with the treating doctor.

Are there any known side effects of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol)?

Yes, there are known side effects of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol). Some common side effects include headache, back pain, pneumonia, cough, and throat irritation. Other possible side effects may include urinary tract infection, respiratory infections, gastrointestinal infections, and muscle spasms. Patients who experience any allergic reactions, such as swelling or difficulty breathing, should seek medical attention immediately. It is important to discuss any potential side effects and concerns with the treating doctor.

Clinical trials

The approval of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) by the Food and Drug Administration (FDA) of the USA for the maintenance treatment of COPD patients was based on the data pooled from Trial 1 and Trial 2. These were double-blind, placebo-controlled, parallel-group, multicenter studies that involved 1239 randomized COPD patients who were given once-daily treatment with fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg co-administered with umeclidinium (UMEC) 62.6 mcg, or FF/VI + UMEC 125 mcg, or FF/VI + placebo. Lung function was measured to assess the efficacy of triple therapy, including the primary outcome, change from baseline in trough (predose) FEV1 at Day 85, and the secondary endpoint, 0-6 h post-dose weighted mean (WM) FEV1 at Day 84. The addition of UMEC to FF/VI led to a significantly improved trough FEV1 at day 85, in comparison to the placebo+FF/VI-treated group.

The approval of Trelegy Ellipta for the maintenance treatment of asthma in adults was based on the data from CAPTAIN study, a randomized, double-blind, active controlled, six-arm parallel group, global multicenter study. The study involved 2,436 asthma patients that received FF/UMEC/VI or fluticasone furoate/vilanterol (FF/VI) given once-daily. The main outcome measured was the change from baseline in trough (predose) FEV1 at week 24. After 24 weeks, patients who received fluticasone furoate/umeclidinium/vilanterol 200/62.5/25 µg showed a greater change in FEV1 from baseline in comparison with FF/VI 100/25 mcg double therapy. It was noted that doubling the inhaled corticosteroid dose improved outcomes in asthma patients. For comprehensive information regarding the safety and effectiveness of Trelegy Ellipta, kindly refer to the summary of the product characteristics in the references section.