Is Budamate (budesonide and formoterol) suitable as rescue therapy for an adult patient with asthma or chronic obstructive pulmonary disease (COPD)?

Budamate as Rescue Therapy

Budamate (budesonide/formoterol combination) is NOT appropriate as traditional rescue therapy for COPD or asthma in the conventional sense, but recent evidence supports a novel "maintenance and reliever therapy" (SMART) approach specifically for asthma patients.

Critical Distinction: COPD vs. Asthma

For COPD Patients

Formoterol-containing products are explicitly contraindicated as rescue therapy in COPD. 1

• The FDA label for formoterol clearly states: "Formoterol Fumarate Inhalation Solution is not used to treat sudden symptoms of COPD" and "Always have a rescue inhaler medicine with you to treat sudden symptoms" 1
• Formoterol is indicated only for "long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction" in COPD 1
• Patients with COPD must use a separate short-acting β2-agonist (SABA) such as albuterol for acute symptom relief 2
• Budesonide/formoterol 160/4.5 μg twice daily has demonstrated efficacy as maintenance therapy in severe and very severe COPD, improving lung function, symptoms, and reducing exacerbations, but this is scheduled maintenance treatment, not rescue use 3, 4

For Asthma Patients

The evidence supports a paradigm shift: budesonide/formoterol can be used as both maintenance AND reliever therapy in asthma (SMART regimen), but this differs fundamentally from traditional rescue-only use. 5, 6

• The SMART (Symbicort Maintenance and Reliever Therapy) dosing regimen allows budesonide/formoterol to be used as both scheduled maintenance medication AND as-needed for symptom relief in asthma patients 5
• This approach has demonstrated "significantly lower rates of exacerbations and reliever medication use compared with fixed-dosing regimens in asthma" 5
• The most compelling recent evidence comes from the 2022 MANDALA trial, which demonstrated that a fixed-dose combination of albuterol-budesonide as rescue medication reduced the risk of severe asthma exacerbation by 26% compared with albuterol alone (hazard ratio 0.74; 95% CI 0.62-0.89; P=0.001) in patients with uncontrolled moderate-to-severe asthma 7

Evidence-Based Recommendations by Clinical Scenario

Asthma: Maintenance and Reliever Therapy (SMART)

For patients with moderate-to-severe persistent asthma already on inhaled corticosteroid-containing maintenance therapy:

• Budesonide/formoterol can be prescribed as both scheduled maintenance (typically twice daily) AND as-needed for acute symptom relief 5, 6
• This dual-use strategy addresses both the bronchospasm AND the underlying inflammation that worsens during symptom exacerbations 7
• The rapid onset of action (predominantly due to formoterol) makes this approach feasible, with bronchodilation occurring within minutes 5, 6
• Adjustable maintenance dosing with budesonide/formoterol resulted in significantly lower overall drug use while maintaining equivalent or better asthma control compared with fixed dosing 6

Asthma: Traditional Rescue-Only Approach

The 2022 MANDALA trial supports using albuterol-budesonide combination as rescue medication even when patients are on separate maintenance therapy:

• Patients with uncontrolled moderate-to-severe asthma on various inhaled glucocorticoid-containing maintenance therapies experienced significantly fewer severe exacerbations when using albuterol-budesonide (180 μg/160 μg per dose) as rescue medication versus albuterol alone 7
• This represents a novel approach where the rescue inhaler itself contains both a SABA and an inhaled corticosteroid, addressing the limitation that "SABAs do not address worsening inflammation, which leaves patients at risk for severe asthma exacerbations" 7
• The safety profile was similar between combination and albuterol-alone groups 7

COPD: Maintenance Only

Budesonide/formoterol must be used as scheduled maintenance therapy only in COPD, never as rescue medication:

• Administer budesonide/formoterol 160/4.5 μg (two inhalations) twice daily as maintenance therapy for severe and very severe COPD 3, 4
• This provides "additive benefits over one or the other of its monocomponents with respect to improvements in morning predose and 1-h postdose lung function" 3
• Patients must carry a separate SABA (albuterol/salbutamol) for acute symptom relief 2, 1
• The combination therapy in COPD reduces exacerbations and improves health status compared to placebo or monotherapy, but only when used as scheduled maintenance 3, 4

Critical Pitfalls to Avoid

Never prescribe formoterol-containing products as rescue-only therapy in COPD 1

• This violates FDA labeling and leaves patients without appropriate acute bronchodilator therapy 1

Never use LABA monotherapy (formoterol alone) in asthma 8

• LABAs must always be combined with inhaled corticosteroids due to increased risk of severe exacerbations and asthma-related deaths when used alone 8

Do not confuse SMART dosing (maintenance + reliever) with rescue-only use 5

• SMART requires scheduled maintenance doses PLUS as-needed use, not as-needed use alone 5

Recognize that increasing SABA use (>2 days/week) indicates inadequate asthma control requiring step-up in controller therapy 2

• This signals the need for better maintenance therapy, not just more rescue medication 2

In acute severe asthma exacerbations, short-acting β2-agonists remain the definitive first-line treatment 2

• Nebulized salbutamol 5 mg or equivalent, repeated 4-6 hourly if improving, with systemic corticosteroids and ipratropium bromide as adjunctive therapy 2
• Budesonide/formoterol as rescue therapy is for mild-to-moderate symptom worsening, not life-threatening exacerbations requiring emergency care 7