What is an alternative to Dulera (fluticasone propionate/salmeterol)?

Alternative to Dulera (Mometasone/Formoterol)

Budesonide/formoterol (Symbicort) is the preferred alternative to Dulera for most patients with moderate to severe persistent asthma, offering equivalent efficacy with the unique advantage of SMART protocol capability (maintenance and reliever therapy). 1, 2

Primary Alternative: Budesonide/Formoterol (Symbicort)

For patients ≥12 years with moderate to severe persistent asthma, budesonide/formoterol 160/4.5 mcg twice daily is the first-choice alternative. 1, 2 This combination provides several clinical advantages over Dulera:

• Formoterol's rapid onset of action (≈1 minute) allows it to function as both controller and reliever medication, eliminating the need for a separate rescue inhaler—a capability unique to formoterol-containing products. 2, 3

• The SMART protocol permits additional inhalations as needed for symptom relief (maximum 8 puffs/day for ages 5-11, or 10 puffs/day for ages ≥12), delivering an inhaled corticosteroid dose with every rescue inhalation and thereby reducing exacerbations. 1, 3

• Budesonide/formoterol reduces hospitalizations/emergency-room visits by 28-37% compared to other ICS/LABA combinations in head-to-head trials. 4

Other ICS/LABA Combination Alternatives

Fluticasone/salmeterol (Advair) is an effective alternative for maintenance therapy only, but it cannot be used for SMART protocol due to salmeterol's slower onset of action (15-30 minutes). 5, 2, 3

• Fluticasone/salmeterol is available as both dry-powder inhaler (Diskus) and metered-dose inhaler (HFA), providing device options when patient preference is a concern. 3

• This combination improves lung function and asthma symptoms to a greater extent than ICS monotherapy, with sustained efficacy for 1 year in well-designed trials. 6, 7

Fluticasone/vilanterol offers once-daily dosing for patients where adherence is the primary concern, though it requires a separate rescue inhaler and cannot be used for SMART protocol. 1, 2

Step-Down Alternatives for Milder Asthma

For mild to moderate persistent asthma (Step 2), low-dose ICS monotherapy is the preferred approach: fluticasone, budesonide, or beclomethasone administered twice daily. 5, 1

Leukotriene receptor antagonists (montelukast or zafirlukast) serve as alternative therapy for patients unable or unwilling to use ICS, offering once-daily dosing with high compliance rates, though they are less effective than ICS. 5, 1

• Montelukast is taken once daily, whereas zafirlukast requires twice-daily dosing. 5

Algorithmic Selection Based on Clinical Context

For Moderate-Severe Persistent Asthma (Steps 3-4):

1. Switch to budesonide/formoterol 160/4.5 mcg twice daily with SMART protocol capability as first choice. 1, 2
2. If SMART protocol is not needed or patient prefers once-daily dosing, consider fluticasone/vilanterol. 1, 2
3. If device preference is critical, select fluticasone/salmeterol for Diskus availability. 3

For Mild Persistent Asthma (Step 2):

1. Step down to low-dose ICS monotherapy (budesonide 200 µg twice daily or equivalent). 5, 1, 3
2. If ICS cannot be tolerated, use leukotriene receptor antagonist (montelukast) as alternative controller therapy. 5, 1

For COPD Patients:

1. LAMA monotherapy (tiotropium) is the first-line alternative, reducing exacerbations and hospitalizations by 39% compared to placebo. 2
2. For severe COPD (FEV1 <50%, ≥2 exacerbations/year), ICS/LABA combination remains appropriate. 2

Critical Safety Considerations and Common Pitfalls

Never use LABA monotherapy for asthma control—LABAs must always be combined with ICS due to increased risk of severe exacerbations and death, with a black-box warning applying to every LABA-containing product. 5, 1, 2, 3

Avoid using salmeterol-containing combinations (like Advair) for SMART protocol, as salmeterol's slower onset of action makes it unsuitable for reliever therapy. 1, 2, 3

Monitor rescue inhaler use closely: use more than 2 days per week indicates inadequate asthma control and necessitates treatment escalation, not continuation of current therapy. 5, 1

Never switch a patient from any ICS/LABA combination to albuterol monotherapy alone, as this eliminates essential anti-inflammatory controller therapy and markedly increases the risk of severe asthma exacerbations. 3

When stepping down therapy in well-controlled patients, transition to low-dose ICS monotherapy (e.g., budesonide 200 µg twice daily) rather than eliminating the controller altogether. 3

ICS-containing regimens increase pneumonia risk in COPD patients (though less relevant for asthma), requiring frequent monitoring. 2

Dose Equivalence Considerations

Fluticasone propionate is more potent than budesonide on a microgram-per-microgram basis: approximately 250 µg of fluticasone provides anti-inflammatory activity comparable to 400 µg of budesonide. 3

When transitioning between different ICS/LABA combinations, adjust the prescribed dose according to established equivalency ratios rather than matching microgram amounts directly. 3