Breztri Aerosphere is a fixed-dose inhaled triple therapy containing budesonide, glycopyrrolate, and formoterol fumarate for maintenance treatment of chronic obstructive pulmonary disease. It combines ICS, anticholinergic, and LABA mechanisms in a single inhaler. The product has U.S. approval beginning in 2020 and is prescription-only.
FDA approves AstraZeneca's Breztri Aerosphere as the first single-inhaler triple therapy for asthma in patients aged 12+, based on Phase III KALOS and LOGOS trials showing improved lung function and reduced exacerbations versus dual therapy.
AstraZeneca announced positive Phase III trial results for Breztri Aerosphere in uncontrolled asthma patients, showing statistically significant improvements over dual-combination therapies. Deutsche Bank maintained a Sell rating with a £115 price target.
Phase III KALOS and LOGOS trial results published in The Lancet Respiratory Medicine show Breztri Aerosphere improved lung function and reduced severe asthma exacerbations compared to dual-combination therapies in patients with uncontrolled asthma.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06531798 |
Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease |
RECRUITING | PHASE4 |
| NCT05472350 |
Efficacy and Safety of Perioperative Use of Breztri Aerosphere to Relieve Cough After Lobectomy |
UNKNOWN | NA |
