What is Breztri (budesonide, glycopyrrolate, and formoterol)?

Breztri: Triple Therapy for COPD Maintenance Treatment

Breztri (budesonide/glycopyrrolate/formoterol) is a fixed-dose combination inhaled medication containing an inhaled corticosteroid (budesonide), a long-acting muscarinic antagonist (glycopyrrolate), and a long-acting β2-agonist (formoterol) delivered via a pressurized metered-dose Aerosphere inhaler for the maintenance treatment of chronic obstructive pulmonary disease (COPD). 1

Components and Mechanism

• Budesonide: An inhaled corticosteroid that provides anti-inflammatory effects in the airways 2
• Glycopyrrolate: A long-acting muscarinic antagonist (LAMA) that produces bronchodilation through muscarinic receptor blockade 1
• Formoterol: A long-acting β2-agonist (LABA) that provides long-acting bronchodilation 2

Clinical Efficacy

• Breztri significantly reduces the rates of moderate to severe COPD exacerbations compared to dual therapies (budesonide/formoterol or glycopyrrolate/formoterol) 1
• The medication improves lung function parameters, particularly forced expiratory volume in one second (FEV1), to a greater extent than dual therapy options 3
• Breztri demonstrates beneficial effects on dyspnea (shortness of breath), reduces rescue medication requirements, and improves health-related quality of life in patients with COPD 1
• In the ETHOS trial, the higher-dose formulation (320/18/9.6 μg) significantly reduced all-cause mortality compared with glycopyrrolate/formoterol dual therapy (hazard ratio 0.51; 95% CI 0.33-0.80) 4

Dosing and Administration

• Breztri is administered as two inhalations twice daily via the Aerosphere pressurized metered-dose inhaler 5
• Available in a formulation containing 160 μg budesonide, 9 μg glycopyrrolate, and 4.8 μg formoterol per inhalation 5

Indications

• Indicated for maintenance treatment of patients with moderate to severe COPD who are insufficiently controlled by dual therapy with either LABA/LAMA or ICS/LABA combinations 5
• Particularly beneficial for patients experiencing symptoms and exacerbations despite current therapy 6
• Most appropriate for patients with a history of COPD exacerbations and symptoms despite optimized bronchodilator therapy 2

Clinical Considerations

• Breztri should not be used for the relief of acute symptoms (not a rescue medication) 2
• The medication is most beneficial in patients with higher blood eosinophil counts, with mortality benefits increasing with higher eosinophil levels 5
• Real-world data shows Breztri is commonly prescribed to patients with various chronic comorbidities, most often cardiopulmonary-related conditions 6

Safety Profile

• Generally well-tolerated with a safety profile similar to that of the individual components 1
• Common side effects include upper respiratory tract infections, pneumonia, oral candidiasis, and headache 1
• As with other inhaled corticosteroid-containing therapies, there is an increased risk of pneumonia in COPD patients 2
• Cardiovascular deaths occurred in 0.5% of patients in the higher-dose Breztri group compared to 1.4% in the glycopyrrolate/formoterol group in clinical trials 4

Advantages Over Dual Therapy

• Provides three complementary mechanisms of action in a single inhaler device, potentially improving adherence 2
• Reduces exacerbation rates more effectively than dual therapies (either ICS/LABA or LAMA/LABA) 1
• May reduce all-cause mortality compared to LAMA/LABA therapy (glycopyrrolate/formoterol) 4
• Offers a convenient option for patients requiring step-up therapy from dual combinations 2

Breztri represents an important treatment option for patients with moderate to severe COPD, particularly those with a history of exacerbations who remain symptomatic despite dual therapy with either LABA/LAMA or ICS/LABA combinations.