What are the active medications in Trelegy Ellipta, its approved dosage strength, dosing frequency, and approved indications for chronic obstructive pulmonary disease and asthma?

Trelegy Ellipta Composition and Clinical Use

Trelegy Ellipta contains three active medications delivered in a single dry powder inhaler: fluticasone furoate 100 mcg (inhaled corticosteroid), umeclidinium 62.5 mcg (long-acting muscarinic antagonist/LAMA), and vilanterol 25 mcg (long-acting beta-2 agonist/LABA), administered once daily. 1

Active Medication Components

The triple therapy combination consists of:

• Fluticasone furoate (FF) 100 mcg - an inhaled corticosteroid (ICS) that reduces airway inflammation 1, 2
• Umeclidinium (UMEC) 62.5 mcg - a long-acting muscarinic antagonist (LAMA) that provides anticholinergic bronchodilation 1, 2
• Vilanterol (VI) 25 mcg - a long-acting beta-2 agonist (LABA) that provides beta-agonist bronchodilation 1, 2

Dosing Specifications

• Dosage strength: The only available strength is FF/UMEC/VI 100/62.5/25 mcg 1, 2
• Dosing frequency: Once-daily administration in the morning using the ELLIPTA dry powder inhaler 1, 2
• Device: All three medications are delivered via a single ELLIPTA inhaler, eliminating the need for multiple devices 2

Approved Indications

COPD Indication

Trelegy Ellipta is licensed for maintenance treatment of adults with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately controlled on a combination of an ICS and a LABA. 1

The evidence supporting this indication demonstrates:

• Lung function improvement: Single-inhaler FF/UMEC/VI improved trough FEV1 by 113 mL at 24 weeks, demonstrating non-inferiority to using two separate inhalers 2
• Exacerbation reduction: Patients experienced significantly fewer exacerbations (0.2 events/year during treatment versus 1.4 events/year pre-study) 3
• Symptom improvement: CAT scores improved by 2.6 units at 12 months, exceeding the threshold for clinical importance 3
• Quality of life: Approximately 50% of patients achieved responder status on St. George's Respiratory Questionnaire 2

Patient Population Characteristics

The medication has been studied in COPD patients with:

• Age: Typically ≥40 years, with mean age around 66-67 years in real-world studies 2, 3
• Disease severity: Moderate to severe COPD with mean FEV1 approximately 52-53% of predicted 3
• Exacerbation history: ≥1 moderate/severe exacerbation in the 12 months before treatment 2
• Symptom burden: Mean CAT scores around 21.5 units at baseline, indicating significant symptom burden 3

Treatment Escalation Pathway

In clinical practice, approximately 64% of patients are escalated to Trelegy from dual ICS/LABA therapies, while 18% are switched from multiple-inhaler triple therapies to simplify their regimen. 3

This aligns with the positioning that triple therapy should be added when:

• Patients remain symptomatic despite optimal dual bronchodilator therapy (LABA/LAMA) 4
• Patients have frequent exacerbations (≥2 per year or ≥1 requiring hospitalization) 4
• Patients have elevated peripheral eosinophil counts suggesting ICS responsiveness 4

Asthma Indication

While the provided evidence focuses primarily on COPD, the combination of ICS/LABA components (fluticasone furoate/vilanterol) has established use in asthma management 5. The full triple therapy formulation with umeclidinium added is specifically indicated for COPD rather than asthma as a primary indication 1.

Clinical Considerations

The once-daily dosing and single-inhaler delivery system addresses a critical problem: up to 76% of COPD patients make critical errors with inhaler use, and device consolidation improves adherence. 6

The safety profile shows:

• Adverse events occurred in approximately 48% of patients, comparable to dual therapy regimens 2
• Serious adverse events occurred in 10-11% of patients 2
• No new safety signals were identified in real-world effectiveness studies 3