What is the recommended dose of vilanterol (long-acting beta2-adrenergic agonist) for chronic obstructive pulmonary disease (COPD) and asthma?

Vilanterol Dosing for COPD and Asthma

The recommended dose of vilanterol is 25 mcg once daily, administered in the morning as part of a fixed-dose combination product (either with umeclidinium for COPD or with fluticasone furoate for both COPD and asthma). 1, 2

FDA-Approved Dosing

For COPD:

• Umeclidinium/vilanterol 62.5/25 mcg once daily (equivalent to delivered dose of 55/22 mcg) 1, 2
• Administered once daily in the morning using the Ellipta dry powder inhaler 1, 2

For Asthma:

• Fluticasone furoate/vilanterol 100/25 mcg or 200/25 mcg once daily 3
• First once-daily ICS/LABA approved for asthma 3

Dose Selection Rationale

The 25 mcg vilanterol dose was selected based on rigorous dose-ranging studies:

• A 28-day trial in 602 COPD patients evaluated vilanterol doses from 3 to 50 mcg 1
• The 25 mcg dose demonstrated clinically meaningful improvements in trough FEV1 of 166 mL compared to placebo (95% CI: 129-203 mL) 1
• Higher doses (50 mcg) showed only marginal additional benefit (194 mL improvement) 1
• The 25 mcg dose provided sustained bronchodilation over 24 hours with rapid onset (within 5-10 minutes) 4

Clinical Efficacy Evidence

COPD outcomes with vilanterol 25 mcg:

• Produces dose-dependent improvements in trough FEV1 with treatment differences ≥130 mL versus placebo 5
• Maintains bronchodilation throughout the 24-hour dosing interval 6, 4
• When combined with umeclidinium, provides superior lung function improvement compared to tiotropium monotherapy 2

Asthma outcomes:

• Fluticasone furoate/vilanterol 100/25 mcg once daily is as effective as fluticasone propionate/salmeterol 250/50 mcg twice daily 3
• Significantly reduces severe asthma exacerbation risk compared to ICS alone 3

Safety Profile at Recommended Dose

The 25 mcg vilanterol dose demonstrates excellent tolerability:

• No clinically significant effects on heart rate, blood pressure, QTc intervals, blood glucose, or potassium levels 4, 5
• Adverse event incidence comparable to placebo (10-12% with combination therapy) 6
• Most common adverse events: headache and nasopharyngitis 2
• Low systemic exposure with rapid absorption (median Tmax 5-10 minutes) 4

Critical Safety Considerations

Never use vilanterol as monotherapy for asthma - LABAs must always be combined with inhaled corticosteroids due to increased risk of severe exacerbations and deaths when used alone 7. This FDA warning applies to all LABAs including vilanterol.

Dosing frequency: Vilanterol is administered once daily only - do not exceed this frequency 1, 4. The inherent 24-hour activity was specifically designed for once-daily dosing 4.

Administration Technique

• Use the Ellipta dry powder inhaler device 1, 2
• Administer in the morning for optimal 24-hour coverage 1, 6
• Proper inhaler technique should be taught at first prescription and verified periodically 8
• The Ellipta device is regarded as easy to use compared to other inhalers 2