Budesonide/Glycopyrronium/Formoterol: A Review in COPD

Drugs. 2021 Aug;81(12):1411-1422. doi: 10.1007/s40265-021-01562-6. Epub 2021 Aug 3.

Abstract

Budesonide/glycopyrronium/formoterol (BREZTRI AEROSPHERE™; TRIXEO AEROSPHERE™) is an inhaled fixed-dose combination of the inhaled corticosteroid (ICS) budesonide, the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide and the long-acting β2-agonist (LABA) formoterol fumarate approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD). It is delivered via a pressurized metered-dose Aerosphere inhaler and is formulated using co-suspension delivery technology. In two pivotal phase III trials of 24-52 weeks' duration, budesonide/glycopyrronium/formoterol reduced the rates of moderate/severe COPD exacerbations and improved lung function to a greater extent than budesonide/formoterol and/or glycopyrronium/formoterol. Budesonide/glycopyrronium/formoterol also demonstrated beneficial effects on dyspnoea, rescue medication requirements and health-related quality of life (HR-QOL), and reduced the risk of all-cause mortality. Budesonide/glycopyrronium/formoterol was generally well tolerated, with the tolerability profile being generally similar to that of the individual components. Budesonide/glycopyrronium/formoterol provides a useful and convenient option for the maintenance treatment of COPD, including for patients whose disease is inadequately controlled with dual ICS/LABA or LAMA/LABA therapy.

Plain language summary

Chronic obstructive pulmonary disease (COPD) is an inflammatory lung disease that is characterized by chronic airflow limitation and persistent respiratory symptoms. A step-up treatment approach combining an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and a long-acting β2-agonist (LABA) may provide clinical benefits in patients with COPD whose disease is inadequately controlled by dual therapies (ICS/LABA or LAMA/LABA). Budesonide/glycopyrronium/formoterol (BREZTRI AEROSPHERE™; TRIXEO AEROSPHERE™) is a fixed-dose ICS/LAMA/LABA combination approved for the maintenance treatment of COPD. It is administered twice daily via a single pressurized metered-dose Aerosphere inhaler. Patients with moderate to very severe COPD receiving budesonide/glycopyrronium/formoterol had fewer moderate or severe COPD exacerbations and improved lung function, respiratory symptoms and quality of life compared with patients receiving ICS/LABA or LAMA/LABA therapy. The risk of death was reduced compared with that of patients receiving LAMA/LABA therapy. Budesonide/glycopyrronium/formoterol was generally well tolerated, with similar rates of adverse events to dual therapy. Budesonide/glycopyrronium/formoterol is a useful and convenient option for the maintenance treatment of COPD.

Publication types

  • Review

MeSH terms

  • Administration, Inhalation
  • Adrenergic beta-2 Receptor Agonists / therapeutic use*
  • Bronchodilator Agents / therapeutic use
  • Budesonide / therapeutic use*
  • Drug Combinations
  • Formoterol Fumarate / therapeutic use*
  • Glucocorticoids / therapeutic use*
  • Glycopyrrolate / therapeutic use*
  • Humans
  • Metered Dose Inhalers
  • Muscarinic Antagonists / therapeutic use*
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Pulmonary Disease, Chronic Obstructive / physiopathology

Substances

  • Adrenergic beta-2 Receptor Agonists
  • Bronchodilator Agents
  • Drug Combinations
  • Glucocorticoids
  • Muscarinic Antagonists
  • Budesonide
  • Glycopyrrolate
  • Formoterol Fumarate