Is Ellipta (fluticasone furoate/vilanterol) a suitable treatment option for a patient with asthma or chronic obstructive pulmonary disease (COPD) and a history of inadequate control with other medications?

Ellipta (Fluticasone Furoate/Vilanterol) for Asthma and COPD

Ellipta is a highly suitable and guideline-recommended treatment option for patients with asthma or COPD who have inadequate control with other medications, particularly those experiencing frequent exacerbations or requiring step-up therapy beyond monotherapy. 1

FDA-Approved Indications and Dosing

Ellipta (BREO ELLIPTA) is FDA-approved for maintenance treatment of both COPD and asthma, delivered as a once-daily inhalation powder combining fluticasone furoate (an inhaled corticosteroid) and vilanterol (a long-acting beta2-agonist). 1

For COPD:

• Use 100/25 mcg (fluticasone furoate/vilanterol) once daily by oral inhalation 1

For Asthma:

• 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

Guideline Support for ICS/LABA Combination Therapy

Inhaled corticosteroids are the most potent and consistently effective long-term control medication for asthma when used consistently. 2 For patients whose asthma is not sufficiently controlled with inhaled corticosteroids alone, adding a long-acting beta2-agonist is the preferred adjunctive therapy in persons 12 years and older. 2

In COPD management, combining medications of different classes produces better lung function and improved symptoms compared to single agents. 2 The largest effects in terms of exacerbations and health status are seen in patients with FEV1 <50% predicted, where combining ICS/LABA treatment is clearly better than either component drug used alone. 2

When to Use Ellipta: Clinical Decision Algorithm

Step 1: Determine Disease Severity and Control Status

For asthma patients:

• If mild persistent asthma (Step 2 care) is inadequately controlled on low-dose inhaled corticosteroids alone, consider stepping up to ICS/LABA combination 2
• If moderate to severe persistent asthma (Steps 3-4), ICS/LABA combinations like Ellipta are appropriate first-line maintenance therapy 2

For COPD patients:

• If FEV1 <50% predicted with history of ≥1 exacerbation requiring oral corticosteroids or antibiotics in the past year, ICS/LABA combination is recommended 2
• Patients with frequent exacerbations (≥2 per year) benefit most from ICS/LABA therapy 3

Step 2: Assess for Specific Phenotypes That Predict ICS Response

Patients more likely to respond to Ellipta include those with:

• Asthma-COPD overlap syndrome 4
• Sputum and/or blood eosinophilia 4
• Brisk bronchodilator response 4
• Frequent exacerbations despite bronchodilator therapy 4

Step 3: Rule Out Contraindications

Do not use Ellipta for:

• Primary treatment of status asthmaticus or acute episodes requiring intensive measures 1
• Patients with severe hypersensitivity to milk proteins 1
• Relief of acute bronchospasm (not a rescue medication) 1

Evidence for Efficacy in Inadequately Controlled Disease

ICS/LABA combinations produce greater changes in spirometry and symptoms than single agents alone. 2 In COPD patients with FEV1 <50% predicted, combining fluticasone furoate and vilanterol significantly reduces exacerbations and improves health status compared to either component used alone. 2

For asthma, combining long-acting beta2-agonists with inhaled corticosteroids is effective and safe when inhaled corticosteroids alone are insufficient, and such combinations are an alternative to increasing the dosage of inhaled corticosteroids. 2

Critical Safety Considerations and Monitoring

Never use Ellipta in combination with additional LABA-containing therapy due to overdose risk. 1 Long-acting beta2-agonists are not recommended for use as monotherapy for long-term control of persistent asthma, as LABA monotherapy increases the risk of serious asthma-related events. 2, 1

Monitor for:

• Oral candidiasis (advise patients to rinse mouth with water without swallowing after each use) 1
• Increased risk of pneumonia in COPD patients 1
• Paradoxical bronchospasm (discontinue if occurs) 1
• Cardiovascular effects from beta-adrenergic stimulation 1
• Decreased bone mineral density with long-term use 1
• Growth suppression in pediatric patients 1
• Glaucoma and cataracts with long-term ICS use 1

Device Advantages Supporting Adherence

The Ellipta device demonstrates high patient satisfaction and preference over other inhalers. 5 In qualitative studies, 71% of asthma patients preferred Ellipta to DISKUS and 60% to metered-dose inhalers, while 86% of COPD patients preferred Ellipta to DISKUS. 5 The device is described as straightforward to operate with ergonomic design, good mouthpiece fit, and highly visible dose counter. 5 This ease of use may positively impact adherence to therapy, which is critical for patients with inadequate disease control. 5

Common Pitfalls to Avoid

• Do not initiate Ellipta during acute exacerbations or acutely deteriorating disease 1
• Do not use as rescue therapy for acute symptoms 1
• Do not combine with other LABA-containing medications 1
• Do not abruptly discontinue systemic corticosteroids when transferring to Ellipta; wean slowly to avoid adrenal insufficiency 1
• Do not assume all patients will respond equally; those without eosinophilia or frequent exacerbations may derive less benefit from ICS component 4