What are the alternatives to Dulera (formoterol and mometasone) for asthma or Chronic Obstructive Pulmonary Disease (COPD) treatment?

Alternatives to Dulera (Mometasone/Formoterol)

For asthma, budesonide/formoterol (Symbicort) is the preferred alternative to Dulera, offering the unique advantage of SMART protocol (maintenance and reliever therapy) for patients ≥12 years at steps 3-4, with superior exacerbation reduction compared to other ICS/LABA combinations. 1, 2, 3

Primary Alternative: Budesonide/Formoterol (Symbicort)

Budesonide/formoterol is the most extensively studied ICS/LABA combination and offers therapeutic advantages over Dulera:

• SMART Protocol capability: Can be used as both maintenance therapy AND rescue therapy (up to 10 puffs/day for ages ≥12 years), which Dulera cannot provide 1, 2, 3
• Superior exacerbation prevention: Reduces hospitalizations/emergency room visits by 28-37% compared to other ICS/LABA fixed-dose combinations 4
• Rapid onset of action: Formoterol provides symptom relief within minutes, similar to short-acting beta-agonists 2
• Standard dosing: 160/4.5 mcg, two inhalations twice daily for moderate to severe asthma 2

Other ICS/LABA Combination Alternatives

Fluticasone/Salmeterol (Advair)

• Effective for maintenance therapy only - cannot be used for SMART protocol due to salmeterol's slower onset of action 1, 3
• Requires separate rescue inhaler (albuterol) 3
• Similar efficacy to other ICS/LABA combinations for symptom control and lung function 5
• Higher hospitalization risk: 28% more hospitalizations compared to budesonide/formoterol fixed-dose 4

Fluticasone/Vilanterol

• Once-daily dosing option for improved adherence 6
• Maintenance therapy only - requires separate rescue inhaler 6
• Cannot be used for SMART protocol 6

Fluticasone/Formoterol

• Contains formoterol with rapid onset, but less extensively studied than budesonide/formoterol 5
• Theoretically could be used for SMART, but lacks the evidence base of budesonide/formoterol 1

COPD-Specific Alternatives

For COPD patients, the treatment algorithm differs significantly from asthma:

LAMA Monotherapy (Tiotropium/Spiriva)

• First-line alternative for COPD - superior to LABAs in reducing exacerbations and hospitalizations 1
• Reduces dyspnea incidence by 39% compared to placebo 6
• Lower pneumonia risk compared to ICS-containing regimens (4% vs 8% with ICS/LABA) 6
• Reduced myocardial infarction risk versus placebo 6

LABA/LAMA Dual Bronchodilators

• Preferred for GOLD B COPD patients - avoids corticosteroid-related adverse effects including pneumonia 6
• Greater lung function improvement than LAMA alone 1
• Appropriate for patients without frequent exacerbations 6

Triple Therapy (ICS/LABA/LAMA)

• Reserved for severe COPD: FEV1 <50% predicted AND ≥1 exacerbation requiring systemic steroids/antibiotics in past year 6
• Improves lung function, symptoms, and reduces exacerbations compared to ICS/LABA or LAMA alone 1
• Higher pneumonia risk - use cautiously in patients at risk 6

Roflumilast (PDE4 Inhibitor)

• For severe COPD with chronic bronchitis and history of exacerbations 1
• Reduces moderate and severe exacerbations 1
• More adverse effects than inhaled medications 1

Stepwise Selection Algorithm

For Asthma (Ages ≥12 years):

Step 3 (Moderate Persistent):

• First choice: Budesonide/formoterol 160/4.5 mcg twice daily with SMART protocol 1, 2
• Alternative: Fluticasone/salmeterol 250/50 mcg twice daily (requires separate rescue inhaler) 3

Step 4 (Moderate-Severe Persistent):

• First choice: Budesonide/formoterol 160/4.5 mcg twice daily with SMART protocol 1, 2
• Alternative: Medium-dose ICS/LABA (any combination) 3

Step 5 (Severe Persistent):

• High-dose ICS/LABA (budesonide/formoterol 320/9 mcg twice daily OR fluticasone/salmeterol 500/50 mcg twice daily) 3
• Consider adding tiotropium (LAMA) for additional control 3
• Consider biologics (omalizumab for allergic asthma) 3

For COPD:

Moderate COPD (FEV1 50-80%, infrequent exacerbations):

• First choice: LAMA monotherapy (tiotropium) 1, 6
• Alternative: LABA/LAMA combination 6

Severe COPD (FEV1 <50%, ≥2 exacerbations/year):

• First choice: ICS/LABA combination 1, 6
• Consider: Triple therapy (ICS/LABA/LAMA) 1, 6

Asthma-COPD Overlap Syndrome (ACOS):

• Preferred: ICS/LABA combinations (treat as asthma) 6

Critical Safety Considerations

Formoterol-specific advantages:

• Never use LABA monotherapy for asthma - must always combine with ICS due to increased risk of severe exacerbations and death 1, 2, 3
• Formoterol is the ONLY LABA appropriate for SMART protocol due to rapid onset 1, 2
• Maximum daily formoterol dose: 24 mcg per day 2

ICS-related risks:

• Pneumonia risk: ICS-containing regimens increase pneumonia risk in COPD (8% vs 4% with LAMA alone) 6
• Oral candidiasis, hoarse voice, skin bruising 1
• Potential increased risk of diabetes, cataracts, mycobacterial infection 1

Monitoring requirements:

• Frequent rescue inhaler use (>2 days/week) indicates inadequate control - requires treatment escalation 2, 3
• Use spacer and mouthwashing technique to reduce local side effects 2

Common Pitfalls to Avoid

• Do not prescribe salmeterol-containing products for SMART protocol - slower onset makes them inappropriate for rescue therapy 1, 3
• Do not use mometasone/formoterol (Dulera) for SMART - less extensively studied than budesonide/formoterol, though theoretically possible 1
• Do not use ICS/LABA in COPD without clear indication (FEV1 <50-60% AND ≥2 exacerbations/year) due to pneumonia risk 1, 6
• Ensure patients understand which inhaler is for maintenance vs. rescue when not using SMART protocol 1