What is the role of Long-Acting Beta-Agonist (LABA) / Inhaled Corticosteroid (ICS) for Maintenance And Reliever Therapy (MART)?

From the Guidelines

LABA/ICS combination therapy, specifically formoterol/budesonide, is the recommended treatment for MART therapy in asthma management, as it provides both daily maintenance and as-needed symptom relief. This approach is supported by the most recent guidelines, which emphasize the importance of combining a LABA with an ICS in a single inhaler for patients with moderate to severe asthma 1. The use of formoterol/budesonide, such as 4.5/160 mcg per dose, once or twice daily as maintenance, plus additional inhalations as needed for symptom relief, has been shown to reduce exacerbations and improve asthma control compared to fixed-dose regimens with separate rescue inhalers.

Key Points

• The combination of a LABA and ICS in a single inhaler is the preferred treatment for MART therapy, as it addresses both bronchoconstriction and underlying inflammation.
• Formoterol/budesonide is a commonly recommended LABA/ICS combination for MART therapy, due to its rapid onset of action and suitability for symptom relief.
• A typical regimen involves taking 1-2 inhalations of formoterol/budesonide once or twice daily as maintenance, plus additional inhalations as needed for symptom relief, generally not exceeding 8 total inhalations per day.
• Other formoterol-containing combinations, such as formoterol/beclomethasone, can also be used for MART therapy.
• MART therapy is particularly beneficial for patients with moderate to severe asthma who experience symptom variability and have a history of exacerbations despite regular controller therapy, as it provides immediate symptom relief while simultaneously increasing anti-inflammatory medication when asthma worsens 1.

Benefits of MART Therapy

• Reduces exacerbations compared to fixed-dose regimens with separate rescue inhalers
• Provides immediate symptom relief while simultaneously increasing anti-inflammatory medication when asthma worsens
• Addresses both bronchoconstriction and underlying inflammation
• Suitable for patients with moderate to severe asthma who experience symptom variability and have a history of exacerbations despite regular controller therapy 1.

From the FDA Drug Label

Use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death [see Salmeterol Multicenter Asthma Research Trial (SMART)] When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone A meta-analysis of the 3 adult and adolescent trials did not show a significant increase in risk of a serious asthma-related event with ICS/LABA fixed-dose combination compared with ICS alone

The use of LABA/ICS for MART therapy is supported by the data, as it does not show a significant increase in the risk of serious asthma-related events compared to ICS alone 2.

• The hazard ratio for serious asthma-related events was 1.10 (95% CI: 0.85,1.44) for ICS/LABA compared to ICS.
• The data suggests that LABA/ICS can be used for MART therapy without a significant increase in the risk of serious asthma-related events.

From the Research

LABA/ICS for MART Therapy

• The combination of formoterol and inhaled corticosteroids (ICS) has an established scientific rationale and demonstrated to reduce asthma exacerbations 3.
• Maintenance and Reliever Therapy (MART) with LABA/ICS has been shown to be effective in enhancing asthma control by improving adherence through the combination of both maintenance and reliever therapy in a single inhaler 3, 4.
• The use of a single inhaler containing the combination of an ICS and formoterol for both maintenance and quick relief therapy is recommended by both the Global Initiative for Asthma and the National Asthma Education and Prevention Program Coordinating Committee 4.

Key Characteristics of Ideal Inhalers

• The ideal inhaler should guarantee accuracy, dose consistency, and resistance to stress conditions 3.
• Easyhaler® has been shown to demonstrate many expected characteristics of an ideal inhaler, including effective and consistent performance regardless of inspiration rate, stability, and versatility 3.
• Other inhalers, such as pMDIs, have also been shown to be effective and convenient for LABA/ICS combination therapy 5, 6.

Efficacy and Safety of LABA/ICS Combinations

• Fluticasone/formoterol has been shown to be more efficacious than fluticasone or formoterol given alone, and provides similar improvements in lung function to fluticasone and formoterol administered concurrently via separate inhalers 7.
• The efficacy and safety of SMART with budesonide-formoterol and beclometasone-formoterol have been confirmed, but other ICS-long-acting bronchodilator combinations have not been studied 4.
• Bioequivalence of a generic fluticasone propionate-salmeterol device has been established, providing an alternative option for patients with asthma or COPD requiring intervention with an ICS/LABA 6.