What is the recommended adult dosing of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for chronic obstructive pulmonary disease and asthma, and when should the dose be increased?

Trelegy Ellipta Dosing for COPD and Asthma

Trelegy Ellipta is dosed as one inhalation of 100/62.5/25 mcg (fluticasone furoate/umeclidinium/vilanterol) once daily in the morning for both COPD and asthma, and the dose should never be increased—only a single strength is available and approved. 1, 2

Standard Dosing Regimen

• One inhalation once daily in the morning is the only approved dosing regimen for Trelegy Ellipta 1, 2
• The fixed-dose combination delivers fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg per actuation 1, 3
• No dose titration or adjustment is possible or recommended—this is a single-strength product 1

Approved Indications

For COPD (Primary Indication)

• Licensed for moderate to severe COPD as maintenance treatment in adults 1
• Specifically indicated when patients are not adequately controlled on ICS/LABA dual therapy 1
• Real-world data demonstrate significant improvements: CAT score reduction of 2.6 units (clinically meaningful threshold), FEV₁ improvement of 93 mL, and dramatic reduction in exacerbation rate from 1.4 to 0.2 events per year 2

For Asthma (Secondary Indication)

• The individual components (FF/VI) have demonstrated 24-hour sustained bronchodilation in respiratory disease, supporting once-daily dosing 4
• Dose delivery remains consistent across peak inspiratory flow rates of 43.5 to 129.9 L/min, ensuring adequate drug delivery even in patients with severe airflow limitation 3

Critical Clinical Context: When NOT to Increase the Dose

There is no higher-strength formulation available, and attempting to use multiple inhalations is not evidence-based and increases risk without proven benefit. 1

If Control Is Inadequate on Trelegy

• Reassess inhaler technique first—over 80% of nominal blister content must be emitted for adequate delivery 3
• Verify adherence—real-world data show better outcomes correlate with consistent daily use 2
• Evaluate for comorbidities: uncontrolled gastroesophageal reflux, obstructive sleep apnea, cardiac dysfunction, or alternative diagnoses 2
• Consider adding adjunctive therapies rather than increasing triple therapy dose: long-acting muscarinic antagonists are already maximized in this combination 1

Dose Emission and Device Performance

• Near-complete dose emission (82.8% to 95.5% of nominal blister content) occurs before reaching peak inspiratory flow, meaning even patients with severe obstruction achieve adequate drug delivery 3
• The ELLIPTA device delivers consistent fine particle fraction across all tested flow rates (30,60, and 90 L/min), ensuring reliable lung deposition regardless of disease severity 3

Common Pitfalls to Avoid

• Never use more than one inhalation per day—no evidence supports this, and it increases systemic corticosteroid exposure without proven efficacy 1, 4
• Do not switch to twice-daily dosing—the pharmacokinetics of vilanterol and fluticasone furoate are specifically designed for 24-hour duration of action 4
• Avoid prescribing Trelegy for mild COPD or as initial therapy—it is indicated only when dual ICS/LABA therapy has failed 1
• Do not use as rescue therapy—this is a maintenance controller medication requiring daily use regardless of symptoms 2

Safety Monitoring

• The combination demonstrates low systemic exposure to all three components at steady state 4
• No clinically significant effects on serum glucose, potassium, vital signs, ECG, or 24-hour serum cortisol have been reported in clinical trials 4
• Adverse event incidence is low (10-12%) and comparable to placebo (4%) in controlled studies 4
• Real-world safety data from 906 patients showed no new safety signals beyond the known profiles of individual components 2