What is the role of Breo Ellipta (fluticasone furoate and vilanterol) in treating Chronic Obstructive Pulmonary Disease (COPD)?

Role of Breo Ellipta in COPD Treatment

Breo Ellipta (fluticasone furoate/vilanterol) is a first-line maintenance therapy for COPD patients with exacerbation history, improving lung function and reducing exacerbation rates compared to monotherapy. 1, 2

Mechanism and Formulation

Breo Ellipta combines two medications in a single inhaler:

• Fluticasone furoate: An inhaled corticosteroid (ICS) that reduces airway inflammation
• Vilanterol: A long-acting beta2-agonist (LABA) that relaxes airway muscles

This combination is delivered via a dry powder inhaler (Ellipta) for once-daily administration, which may improve treatment adherence compared to twice-daily alternatives 3.

Clinical Indications for COPD

Breo Ellipta is FDA-approved for the maintenance treatment of COPD 2, 4. It is particularly beneficial for:

1. Patients with moderate to very severe COPD
2. Patients with a history of exacerbations
3. Patients with persistent symptoms despite bronchodilator monotherapy

Dosing and Administration

• Standard dosage: 1 inhalation of Breo Ellipta 100/25 mcg once daily 2
• Administration should be at the same time each day
• Patients should rinse their mouth with water (without swallowing) after inhalation to reduce the risk of oral candidiasis 2

Clinical Efficacy

Breo Ellipta demonstrates several clinical benefits:

1. Improved lung function: Significantly improves FEV1 compared to placebo and fluticasone furoate alone 3
2. Reduced exacerbation rates: 8.4% reduction in moderate or severe exacerbations compared to usual care 5
3. Symptom control: Improves dyspnea and health status 1

In the SUMMIT trial, while Breo Ellipta did not significantly affect mortality in COPD patients with heightened cardiovascular risk, it did reduce exacerbations and slow FEV1 decline 6.

Placement in Treatment Algorithm

According to the GOLD guidelines, treatment should follow this approach 1:

1. Initial therapy: LABA or LAMA monotherapy for most patients
2. Escalation for persistent symptoms or exacerbations:
   • LABA/LAMA combination for patients without exacerbation history
   • LABA/ICS (like Breo Ellipta) for patients with exacerbation history, especially with blood eosinophil counts ≥300 cells/μL
3. Triple therapy (LABA/LAMA/ICS): Consider for patients with persistent exacerbations despite dual therapy 1, 7

Advantages Over Other Therapies

• Once-daily dosing: Potentially improves adherence compared to twice-daily alternatives 3
• Comparable efficacy: Similar effectiveness to twice-daily fluticasone propionate/salmeterol 500/50 μg with more convenient dosing 3
• Real-world effectiveness: Demonstrated benefits in a large effectiveness trial conducted in general practice settings 5

Adverse Effects and Safety Considerations

Common adverse effects include:

• Nasopharyngitis
• Upper respiratory tract infection
• Headache
• Oral candidiasis

Important safety concerns:

1. Pneumonia risk: Increased risk of pneumonia, particularly in patients who:

   • Currently smoke
   • Are ≥55 years old
   • Have history of pneumonia
   • Have BMI <25 kg/m²
   • Have severe airflow limitation 1

2. Cardiovascular effects: Use with caution in patients with cardiovascular disorders due to beta-adrenergic stimulation 2

3. Other potential effects:

   • Decreased bone mineral density with long-term use
   • Potential for glaucoma and cataracts
   • Potential for adrenal suppression 2, 4

Clinical Pearls and Pitfalls

1. Not for acute symptoms: Breo Ellipta is NOT indicated for relief of acute bronchospasm 2, 4

2. Proper inhaler technique: Poor inhaler technique significantly affects symptom control. Education on proper technique is essential, particularly for older patients and those using multiple devices 1

3. ICS withdrawal considerations: Withdrawal of ICS component may have variable effects on lung function, symptoms, and exacerbations 1

4. Monitoring recommendations:

   • Regular assessment of exacerbation frequency
   • Periodic eye examinations for patients on long-term therapy
   • Monitoring for signs of pneumonia

Conclusion

Breo Ellipta represents an effective once-daily maintenance treatment option for COPD patients, particularly those with exacerbation history. Its combination of fluticasone furoate and vilanterol provides both anti-inflammatory and bronchodilator effects, improving lung function and reducing exacerbation risk. However, clinicians must balance these benefits against the increased risk of pneumonia and monitor patients accordingly.