Drug updated on 11/20/2024
Dosage Form | Inhalation: budesonide (160 mcg), glycopyrrolate (9 mcg), formoterol fumarate (4.8 mcg) per inhalation |
Drug Class | inhaled 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).
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Breztri aerosphere (budesonide, glycopyrrolate, and formoterol fumarate) Prescribing Information. | 2020 | AstraZeneca Pharmaceuticals LP, Wilmington, DE |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Updates from 2023 guidelines: part 2. | 2024 | Canadian Family Physician |
2023 Canadian Thoracic Society Guideline on Pharmacotherapy in Patients With Stable COPD. | 2023 | Chest |
GOLD 2023 Update: Implications for Clinical Practice. | 2023 | International Journal of Chronic Obstructive Pulmonary Disease |
Position paper of the French Society of Respiratory Diseases regarding pharmacological treatment optimization for stable COPD in 2021. | 2022 | Respiratory Medicine and Research |
LABA/LAMA as First-Line Therapy for COPD: A Summary of the Evidence and Guideline Recommendations. | 2022 | Journal of Clinical Medicine |
Update on guidelines for the treatment of COPD in Taiwan using evidence and GRADE system-based recommendations. | 2021 | Journal of the Formosan Medical Association |
Pharmacologic Management of Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline. | 2020 | American Journal of Respiratory and Critical Care Medicine |