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

Role of Breo Ellipta in COPD and Asthma Management

Breo Ellipta (fluticasone furoate/vilanterol) is indicated for the maintenance treatment of both COPD and asthma, providing significant improvements in lung function, symptom control, and exacerbation reduction compared to monotherapy. This combination therapy delivers an inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) in a once-daily dosing regimen that improves adherence and outcomes.

Indications and Formulations

Breo Ellipta is FDA-approved for:

• Maintenance treatment of COPD (100/25 mcg strength) 1
• Maintenance treatment of asthma in patients aged 5 years and older (multiple strengths) 1
  • Adults: 100/25 mcg or 200/25 mcg once daily
  • Adolescents (12-17 years): 100/25 mcg once daily
  • Children (5-11 years): 50/25 mcg once daily

Important limitation: Breo Ellipta is NOT indicated for the relief of acute bronchospasm 1.

Role in COPD Management

Efficacy in COPD

• Reduces moderate and severe exacerbations compared to vilanterol monotherapy 2
• Improves lung function (FEV1) and health status 3
• Provides once-daily dosing convenience, improving adherence 4

Placement in COPD Treatment Algorithm

1. For patients with moderate to severe COPD with exacerbation history:

   • Breo Ellipta (fluticasone furoate/vilanterol) is appropriate when:
     • Patient has moderate to severe COPD with history of exacerbations
     • Blood eosinophil count ≥300 cells/μL 5

2. Treatment selection based on symptom burden:

   • For patients with moderate symptom burden (mMRC score of 2): Consider LABA/ICS combination like Breo Ellipta 5
   • For patients with severe symptoms (mMRC ≥3): Consider triple therapy (adding LAMA) 5

Role in Asthma Management

Efficacy in Asthma

• Significantly improves weighted mean FEV1 compared to fluticasone furoate alone 6
• Increases percentage of rescue-free and symptom-free 24-hour periods 6
• Improves morning and evening peak expiratory flow 6

Dosing Considerations

• For patients not responding adequately to 100/25 mcg, increasing to 200/25 mcg may provide additional asthma control 1
• Maximum recommended dosage is one inhalation of 200/25 mcg once daily 1

Device Characteristics and Patient Acceptability

The Ellipta device offers several advantages:

• Medium resistance dry powder inhaler with consistent dose delivery across various inspiratory flow rates 4
• Once-daily dosing simplifies treatment regimens 4
• Proven easier to use compared to other inhaler devices 4
• Patient preference demonstrated in multiple evaluations 4

Safety Considerations

Important Warnings

• Increased risk of pneumonia in COPD patients 3, 5
  • Monitor for signs and symptoms of pneumonia
  • Higher risk in patients who: currently smoke, are ≥55 years old, have history of pneumonia, have BMI <25 kg/m², or have severe airflow limitation 3
• Potential for oral candidiasis (advise patients to rinse mouth after use) 1
• Not for acute symptom relief 1

Monitoring Recommendations

• Regular assessment of symptom control and exacerbation frequency 5
• Periodic eye examinations for patients on long-term therapy (risk of cataracts/glaucoma) 5
• Monitor for signs of pneumonia, especially in high-risk patients 3, 5

Clinical Decision Algorithm

1. For COPD patients:

   • If moderate to severe COPD with history of exacerbations and eosinophil count ≥300 cells/μL: Breo Ellipta 100/25 mcg once daily
   • If inadequate response or continued exacerbations: Consider triple therapy by adding a LAMA

2. For asthma patients:

   • Adults: Start with Breo Ellipta 100/25 mcg once daily; increase to 200/25 mcg if needed
   • Adolescents (12-17 years): Breo Ellipta 100/25 mcg once daily
   • Children (5-11 years): Breo Ellipta 50/25 mcg once daily

3. For all patients:

   • Ensure proper inhaler technique
   • Monitor for pneumonia and other adverse effects
   • Assess response based on symptom control, exacerbation frequency, and lung function

In real-world clinical practice, Breo Ellipta has demonstrated significant improvements in COPD Assessment Test scores and lung function, with reductions in exacerbation rates, supporting its effectiveness in everyday patient care 7.