Budesonide, glycopyrrolate, formoterol fumarate

(Breztri Aerosphere®)

Breztri Aerosphere®

Drug updated on 11/20/2024

Dosage FormInhalation: budesonide (160 mcg), glycopyrrolate (9 mcg), formoterol fumarate (4.8 mcg) per inhalation
Drug Classinhaled corticosteroid, anticholinergic, long-acting beta2-adrenergic agonist
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

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Summary
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  • This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
  • Triple ICS/LABA/LAMA (inhaled corticosteroid/long-acting β2-adrenoceptor agonist/long-acting muscarinic antagonist) therapies, including Breztri Aerosphere (BUD/GLY/FOR), significantly reduced exacerbations and all-cause mortality compared to dual LAMA/LABA or ICS/LABA therapies. Medium-dose combinations demonstrated superior mortality reduction compared to low-dose or LAMA/LABA therapies.
  • Breztri Aerosphere improved lung function (trough FEV1 (forced expiratory volume in the first second)) and quality of life (SGRQ (St. George’s Respiratory Questionnaire) scores) compared to LAMA/LABA therapies, with efficacy comparable to other triple ICS/LABA/LAMA therapies.
  • In patients with high eosinophil counts, ICS/LABA/LAMA therapy was most effective, followed by LABA/LAMA and ICS/LABA. A similar ranking was observed in patients with low eosinophil counts, with ICS/LABA/LAMA showing the greatest distinction over dual therapies.
  • No significant differences were detected in the risk of serious adverse events, including cardiovascular serious adverse events, across triple fixed-dose combinations. The overall safety profile, including the incidence of serious adverse events, was comparable to other triple therapies.
  • Triple therapies showed a higher incidence of pneumonia compared to dual therapies, representing an important safety concern. The efficacy and safety profiles of ICS/LABA/LAMA therapies differed by eosinophil count, with ICS/LABA/LAMA ranked highest for both low and high eosinophil count patients, followed by LABA/LAMA, and ICS/LABA; a larger gap was observed between LABA/LAMA and ICS/LABA in low eosinophil count patients.

Product Monograph / Prescribing Information

Document TitleYearSource
Breztri aerosphere (budesonide, glycopyrrolate, and formoterol fumarate) Prescribing Information.2020AstraZeneca Pharmaceuticals LP, Wilmington, DE

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines