Is Breo Ellipta (fluticasone furoate/vilanterol) a good therapy option for Chronic Obstructive Pulmonary Disease (COPD)?

Is Breo Ellipta 100 Good Therapy for COPD?

Yes, Breo Ellipta (fluticasone furoate/vilanterol) 100/25 mcg is FDA-approved and guideline-supported therapy for COPD maintenance treatment, but it is NOT first-line therapy for most patients and should be reserved for specific clinical scenarios. 1

When Breo Ellipta IS Appropriate for COPD

ICS/LABA combinations like Breo Ellipta are recommended for COPD patients who meet ALL of the following criteria: 2

• FEV1 <50% predicted (moderate to very severe COPD) 2
• History of ≥2 exacerbations per year OR ≥1 hospitalization for exacerbation 2
• Already on appropriate long-acting bronchodilator therapy (LAMA and/or LABA) 2

Additional patient populations where ICS/LABA may be first-choice: 2

• Asthma-COPD overlap syndrome (ACOS) 2, 3
• Elevated blood eosinophil counts (≥300 cells/µL suggests better ICS response) 2, 3
• Sputum eosinophilia 2, 3

Why Breo Ellipta Is NOT First-Line

LAMA/LABA dual bronchodilator therapy is superior to ICS/LABA for most COPD patients, particularly Group D (high symptoms, high exacerbation risk): 2

• LAMA/LABA combinations showed superior exacerbation prevention compared to ICS/LABA in Group D patients 2
• Group D patients have higher pneumonia risk with ICS treatment 2
• LAMA/LABA provides better patient-reported outcomes than ICS/LABA 2

The 2023 Canadian Thoracic Society guidelines demonstrate that triple therapy (LAMA/LABA/ICS) is more effective than ICS/LABA dual therapy, with 0.91 vs 1.07 exacerbations/year respectively. 2 This means if a patient needs ICS, they should likely be on triple therapy rather than ICS/LABA alone.

Efficacy Evidence for Breo Ellipta

Breo Ellipta reduces COPD exacerbations compared to vilanterol alone: 4

• Pooled analysis showed significantly fewer moderate/severe exacerbations with fluticasone furoate/vilanterol 100/25 mcg vs vilanterol alone (p<0.0001) 4
• Reduces rate of FEV1 decline by 8 mL/year compared to placebo 5

However, Breo Ellipta did NOT improve all-cause mortality in the SUMMIT trial (HR 0.88,95% CI 0.74-1.04, p=0.137), which included patients with moderate COPD and cardiovascular risk. 5

Critical Safety Concerns

Pneumonia risk is significantly increased with ICS-containing regimens: 2

• Regular ICS treatment increases pneumonia risk, especially in severe disease 2
• Eight deaths from pneumonia occurred in fluticasone furoate/vilanterol groups vs none in vilanterol-only groups in pivotal trials 4
• Highest risk patients: current smokers, age ≥55 years, BMI <25 kg/m², prior pneumonia history, severe airflow limitation 2

The number needed to harm is 33 patients for 1 year to cause one pneumonia, while number needed to treat is 4 patients for 1 year to prevent one moderate-to-severe exacerbation with triple therapy vs dual bronchodilator. 2

Other ICS-related adverse effects: 2

• Oral candidiasis, hoarse voice, skin bruising 2
• Increased risk of diabetes/poor glycemic control 2
• Cataracts 2
• Mycobacterial infection including tuberculosis 2
• Bone density loss and fractures 2

Recommended Treatment Algorithm

For newly diagnosed COPD patients: 2

1. Group A (low symptoms, low exacerbation risk): Start with short-acting bronchodilator or single long-acting bronchodilator 2
2. Group B (high symptoms, low exacerbation risk): Start with LAMA or LABA; escalate to LAMA/LABA if persistent breathlessness 2
3. Group C (low symptoms, high exacerbation risk): Start with LAMA 2
4. Group D (high symptoms, high exacerbation risk): Start with LAMA/LABA combination 2

When to add ICS (like Breo Ellipta): 2

• Patient on LAMA/LABA continues to have ≥2 exacerbations/year 2
• Consider escalating to triple therapy (LAMA/LABA/ICS) rather than ICS/LABA alone 2
• Alternative: Switch from LAMA/LABA to ICS/LABA if ACOS features present 2

When NOT to use Breo Ellipta: 1

• Acute bronchospasm relief (not a rescue medication) 1
• Severe milk protein allergy 1
• Patients without exacerbation history on adequate bronchodilator therapy 2

Practical Considerations

Dosing: 1

• Breo Ellipta 100/25 mcg: one inhalation once daily 1
• Once-daily dosing may improve adherence compared to twice-daily ICS/LABA 6, 7

Monitoring requirements: 1

• Regular eye examinations for glaucoma/cataracts 1
• Monitor for signs/symptoms of pneumonia 4
• Assess bone mineral density in high-risk patients 1
• Monitor blood glucose in diabetic patients 2

Common pitfall: Do not step down from triple therapy (LAMA/LABA/ICS) to ICS/LABA in patients at high exacerbation risk, as ICS withdrawal increases exacerbation risk, particularly in those with eosinophils ≥300 cells/µL. 2