In a patient taking Dulera (fluticasone propionate/formoterol) 100 µg/5 µg, two puffs daily, and an albuterol rescue inhaler as needed, who continues to have shortness of breath and a cough worsened by allergies, what is the next best treatment?

Step Up Asthma Therapy: Increase to Medium-Dose ICS-LABA

Before stepping up therapy, first verify adherence to the current Dulera regimen, confirm proper inhaler technique, address environmental allergen exposures, and ensure comorbid conditions (particularly allergic rhinitis) are adequately treated 1.

Current Treatment Assessment

Your patient is on Dulera 100 mcg/5 mcg (mometasone/formoterol), which represents Step 3 therapy in the 2020 NAEPP guidelines—a low-dose ICS-LABA combination 1. The persistent shortness of breath, cough, and need for rescue albuterol indicate inadequate asthma control despite this regimen.

Recommended Next Step

Increase to Dulera 200 mcg/5 mcg, two puffs twice daily 2. This escalates therapy to Step 4 (medium-dose ICS-LABA), which is the preferred treatment for patients not controlled on low-dose ICS-LABA 1.

Rationale for This Approach:

• The FDA label specifically states: "For patients who do not respond adequately after 2 weeks of therapy with two inhalations of DULERA 100 mcg/5 mcg twice daily, increasing the dosage to two inhalations of DULERA 200 mcg/5 mcg twice daily may provide additional asthma control" 2

• Clinical trial data demonstrate that Dulera 200 mcg/5 mcg produces greater improvements in trough FEV1 (0.19 L vs 0.14 L) compared to the 100 mcg/5 mcg dose, with maintained efficacy over 12 weeks 2

• The 2020 NAEPP guidelines designate medium-dose ICS-LABA as the preferred Step 4 therapy for patients inadequately controlled on Step 3 1

Address the Allergy Component

Since the cough is specifically aggravated by allergies:

• Implement multicomponent allergen-specific mitigation strategies targeting identified indoor allergens (dust mites, pets, pests) 1
• Treat concurrent allergic rhinitis aggressively with intranasal corticosteroids and/or antihistamines, as untreated rhinitis significantly worsens asthma control
• Consider allergen immunotherapy as adjunctive therapy once asthma is well-controlled on the stepped-up regimen 1

Alternative Rescue Strategy

Consider switching from albuterol PRN to using the Dulera inhaler itself (ICS-formoterol) 1-2 puffs as needed for symptom relief 1. This approach, supported by the 2020 guidelines for Steps 3-4, provides both bronchodilation and anti-inflammatory effect with each rescue use, potentially reducing exacerbation risk. However, ensure total daily dose does not exceed 8 puffs (maximum 800 mcg/20 mcg daily) 2.

Critical Follow-Up

• Reassess in 2-6 weeks after stepping up therapy 1
• If symptoms persist despite Dulera 200 mcg/5 mcg with confirmed adherence and proper technique, consult with an asthma specialist (recommended at Step 4) 1
• At specialist level, consider adding a long-acting muscarinic antagonist (LAMA) or evaluating for biologic therapy (anti-IgE, anti-IL5, anti-IL4R) if the patient has severe persistent asthma with allergic or eosinophilic phenotype 1

Common Pitfalls to Avoid

• Don't add montelukast as an alternative—the FDA issued a Boxed Warning in March 2020 for neuropsychiatric adverse events, and the 2020 guidelines specifically note LTRAs are "less desirable" due to increased risk of adverse consequences 1
• Don't continue the same dose indefinitely—persistent symptoms despite Step 3 therapy mandate escalation
• Don't forget to have the patient rinse mouth after each dose to reduce risk of oral candidiasis 2