What is the next step in managing a patient with persistent asthma that is uncontrolled on maximum doses of Dulera (mometasone/formoterol) and SABA (Short-Acting Beta Agonist)?

Management of Persistent Asthma Uncontrolled on Maximum Dose Dulera and SABA

Add a long-acting muscarinic antagonist (LAMA) to your current ICS-LABA regimen (Dulera), creating triple therapy with ICS-LABA-LAMA. 1

Stepwise Approach to Escalation

First Priority: Add LAMA to Current Therapy

• For patients aged 12 years and older with uncontrolled persistent asthma on ICS-LABA, adding LAMA to the existing ICS-LABA combination is conditionally recommended over continuing the same dose of ICS-LABA alone 1

• The most studied LAMA for asthma is tiotropium bromide 5 µg once daily via Respimat, which has demonstrated efficacy in reducing exacerbations requiring oral corticosteroids (OR 0.76,95% CI 0.57-1.02) 2

• Triple therapy (ICS-LABA-LAMA) provides additional benefits in lung function (trough FEV1 and FVC) and asthma control scores beyond ICS-LABA alone 2, 3

Before Escalating: Critical Verification Steps

You must verify these factors before adding medications: 4

• Adherence to current medications - confirm the patient is actually taking Dulera as prescribed 4
• Proper inhaler technique - many patients use inhalers incorrectly, negating therapeutic benefit 4
• Environmental control measures - identify and mitigate allergen exposures if relevant 1
• Comorbid conditions - address rhinosinusitis, GERD, obesity, or other conditions worsening asthma 4

Alternative/Additional Considerations

If Allergic Asthma is Present:

Consider adding omalizumab if the patient has documented IgE-mediated allergic asthma with positive skin testing or RAST to perennial aeroallergens 1, 4

• Omalizumab is indicated for patients ≥12 years old with moderate to severe persistent asthma inadequately controlled on ICS therapy who have documented allergic sensitization 1, 4

• This biologic therapy reduces asthma exacerbations even in severe asthma populations 1

Consider ICS-Formoterol as Single Maintenance and Reliever Therapy (SMART):

For patients aged 12 years and older with moderate to severe persistent asthma, ICS-formoterol used as both daily controller and reliever therapy is conditionally recommended over higher-dose ICS-LABA as daily controller with SABA for quick relief 1

• Since Dulera contains formoterol, this approach could be implemented by using Dulera for both maintenance and rescue instead of SABA 1

• This strategy has high certainty of evidence supporting its use 1

Important Safety Considerations

SABA Overuse as a Red Flag:

• Using SABA more than 2 days per week for symptom relief (not prevention of exercise-induced bronchospasm) indicates inadequate control and confirms the need for treatment intensification 1, 4

• Frequent SABA use should prompt immediate escalation of controller therapy 1, 4

What NOT to Do:

• Do NOT add LAMA to ICS alone (without LABA) - this is conditionally recommended against compared to adding LABA to ICS 1

• Do NOT use LABA as monotherapy - the FDA has issued a black-box warning against LABAs without ICS due to increased severe exacerbations and deaths 1, 4

• Do NOT increase ICS dose alone - for patients aged 4 years and older with mild to moderate persistent asthma who are adherent to daily ICS, short-term increases in ICS dose for increased symptoms are conditionally recommended against 1

Clinical Nuances

Evidence Quality Considerations:

The recommendation to add LAMA to ICS-LABA has moderate certainty of evidence and is a conditional recommendation 1. However, this represents the most evidence-based next step for your clinical scenario.

The evidence shows that adding LAMA versus placebo to ICS reduces exacerbation risk (RR 0.67,95% CI 0.48-0.92) 3, though triple therapy versus ICS-LABA showed non-significant improvement (RR 0.84,95% CI 0.57-1.22) 3. Despite mixed statistical significance, guidelines consistently recommend this escalation step.

Monitoring After Escalation:

• Reassess asthma control at 2-6 weeks after adding LAMA 1

• If control remains inadequate despite triple therapy plus verification of adherence/technique/environmental factors, then consider biologic therapy (omalizumab for allergic asthma, or other biologics based on phenotype) 1, 4

• Oral systemic corticosteroids should only be added if control remains inadequate despite high-dose ICS-LABA plus additional controller (LAMA or biologic) 4