What is the role of Trelegy Ellipta (fluticasone furoate, umeclidinium, vilanterol) in managing chronic obstructive pulmonary disease (COPD) or asthma in patients not adequately controlled on other medications?

Trelegy Ellipta for COPD and Asthma Management

Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is indicated for maintenance treatment of moderate to severe COPD in patients inadequately controlled on ICS/LABA combinations, and for maintenance treatment of asthma in patients aged 5 years and older. 1

FDA-Approved Indications

For COPD: Trelegy Ellipta is approved for once-daily maintenance treatment in adults with chronic obstructive pulmonary disease. 1 The standard dose is 100/25 mcg (fluticasone furoate/vilanterol) once daily by oral inhalation. 1

For Asthma: The medication is approved for maintenance treatment in patients aged 5 years and older, with dosing varying by age:

• Adults (≥18 years): 100/25 mcg or 200/25 mcg once daily 1
• Adolescents (12-17 years): 100/25 mcg once daily 1
• Children (5-11 years): 50/25 mcg once daily 1

Role in COPD Treatment Algorithm

Triple therapy with ICS/LAMA/LABA improves lung function, symptoms, health status (Evidence A), and reduces exacerbations (Evidence B) compared with ICS/LABA or LAMA monotherapy. 2

When to Initiate Triple Therapy

Add ICS to LABA/LAMA combination when patients have:

• FEV1 <50% predicted AND ≥2 exacerbations in the previous year 3
• Blood eosinophil count ≥150-200 cells/µL 3
• Asthma-COPD overlap syndrome 3

The European Respiratory Society recommends LABA/LAMA combination as first-line treatment for severe COPD with high exacerbation risk, with ICS added only when the above criteria are met. 3

Clinical Evidence and Efficacy

Real-world studies demonstrate that FF/UMEC/VI significantly reduces:

• COPD exacerbations (p < 0.001) 4
• Dyspnea scores on Modified British Medical Research Council scale (p < 0.0001) 4
• COPD Assessment Test scores (p < 0.0001) 4

Lung function improvements include:

• Increased FEV1 (p < 0.001) 4
• Reduced residual volume and lung hyperinflation (p < 0.01) 4
• Improved peak expiratory flow (p < 0.0001) 4
• Enhanced diffusion lung capacity (p < 0.01) 4

The IMPACT study showed triple therapy had greater effects in reducing moderate-severe exacerbations, improving trough FEV1, and enhancing quality of life compared to dual therapies. 5

Critical Safety Considerations and Contraindications

Absolute contraindications include:

• Primary treatment of status asthmaticus or acute COPD/asthma episodes requiring intensive measures 1
• Severe hypersensitivity to milk proteins or any ingredients 1

Important warnings:

• LABA monotherapy increases risk of serious asthma-related events 1
• Do not initiate in acutely deteriorating COPD or asthma 1
• Do not use with additional LABA-containing therapy due to overdose risk 1
• Increased pneumonia risk in COPD patients—monitor for signs and symptoms 1

Common Pitfalls to Avoid

Not for acute symptom relief: Trelegy Ellipta is NOT indicated for relief of acute bronchospasm. 1 Patients require a separate short-acting bronchodilator for rescue therapy.

Oral candidiasis prevention: Candida albicans infection of the mouth and pharynx may occur. 1 Advise patients to rinse mouth with water without swallowing after each inhalation to reduce this risk.

Systemic corticosteroid transition: When transferring from systemic corticosteroids, wean patients slowly to avoid impaired adrenal function. 1 Risk of hypercorticism and adrenal suppression exists with very high dosages or in susceptible individuals. 1

Infection monitoring: Use with caution in patients with tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex, as these may worsen. 1 More serious or fatal courses of chickenpox or measles can occur in susceptible patients. 1

Practical Administration

Device characteristics: Once-daily administration via a simple dry powder inhaler device may increase adherence and treatment efficacy. 5 Inhaler technique must be demonstrated before prescribing and regularly checked. 3

Patient selection: Triple therapy is most appropriate for severe COPD patients (Group D) who remain symptomatic with frequent exacerbations despite dual bronchodilator therapy. 5, 6 The single-inhaler approach offers convenience over multiple-device regimens while delivering equivalent therapeutic benefit.