Is Annuity Ellipta (fluticasone furoate and vilanterol) a suitable inhaler for the Single inhaler Maintenance And Reliever Therapy (SMART) protocol?

Anoro Ellipta is Not Suitable for SMART Protocol in Asthma Management

Anoro Ellipta (fluticasone furoate/vilanterol) is not appropriate for use in the Single inhaler Maintenance And Reliever Therapy (SMART) protocol because it contains vilanterol, which is a long-acting beta agonist (LABA) with a slower onset of action than formoterol, making it unsuitable for reliever therapy. 1

Why SMART Protocol Requires Specific Medications

SMART protocol requires an inhaler that can function as both maintenance and reliever therapy. The 2020 National Asthma Education and Prevention Program (NAEPP) guidelines specifically state that:

1. Only formoterol-containing combinations are suitable for SMART due to formoterol's rapid onset of action 1
2. Salmeterol and vilanterol have slower onsets of action and should not be used for SMART 1
3. The preferred medication for SMART is ICS/formoterol (typically budesonide/formoterol) 1

Key Requirements for SMART Protocol Medications

• Rapid-onset LABA: The LABA component must have a fast onset of action to provide quick symptom relief 1
• Appropriate ICS component: While most studies were done with budesonide/formoterol, other ICS medications combined with formoterol could theoretically work 1
• Proper dosing capability: The medication must be suitable for both daily maintenance and as-needed relief 1

Limitations of Anoro Ellipta for SMART

• Contains vilanterol: Vilanterol has a slower onset of action compared to formoterol, making it unsuitable for reliever therapy 1
• Once-daily dosing: While Anoro Ellipta's once-daily dosing is convenient for maintenance therapy 2, this dosing schedule is not designed for the as-needed relief component required in SMART
• Delivery system limitations: The Ellipta device, while easy to use 3, is designed for scheduled dosing rather than variable as-needed dosing required for SMART

Appropriate Alternatives for SMART Protocol

For patients requiring SMART protocol, the following options are recommended:

• Budesonide/formoterol: The most extensively studied combination for SMART protocol 1
• Other formoterol-containing combinations: Potentially effective though less extensively studied 1

Important Clinical Considerations

• SMART is currently an off-label use in the United States, even though the boxed warning regarding asthma-related death has been removed from ICS/LABA labels 1
• SMART is recommended for steps 3 and 4 in both children (5-11 years) and adults according to NAEPP guidelines 1
• Insurance coverage may be a practical barrier to implementing SMART, as it requires prescribing the same medication for both maintenance and reliever use 1

While Anoro Ellipta has demonstrated effectiveness in improving asthma control in clinical practice 4, its pharmacological profile makes it unsuitable specifically for the SMART protocol, which requires a medication that can effectively serve both maintenance and reliever functions.