April 28, 2026
2 min read
Key takeaways:
- Breztri Aerosphere combines budesonide, glycopyrrolate and formoterol fumarate in one inhaler.
- The FDA based Breztri Aerosphere’s approval on phase 3 KALOS and LOGOS trial results.
The FDA approved Breztri Aerosphere, a single-inhaler triple therapy, as a maintenance treatment for patients aged at least 12 years with asthma, according to a press release from AstraZeneca.
The Breztri Aerosphere (AstraZeneca) inhaler combines 320 μg budesonide, an inhaled corticosteroid; 36 μg glycopyrrolate, a long-acting muscarinic antagonist; and 9.6 μg formoterol fumarate, a long-acting beta2-agonist, according to the release.
The FDA based Breztri Aerosphere’s approval on results from two phase 3 trials.
Notably, Breztri Aerosphere is already FDA approved as a maintenance treatment for patients with COPD.
The decision to approve the triple therapy in asthma was based on data from two twin, randomized, double-blind, double-dummy, parallel group, phase 3 trials in adults and adolescents with inadequately controlled asthma: KALOS and LOGOS.
The aim of these trials was to determine how treatment with Breztri Aerosphere impacts morning pre-dose trough FEV1 over 24 weeks and FEV1 area under the curve 0 to 3 hours (AUC0-3) at week 24.
Researchers evaluated two different glycopyrrolate doses — 28.8 μg and 14.4 μg — in Breztri Aerosphere in these trials.
Both trials included two comparator groups. One was a combination of 320 μg budesonide and 9.6 μg formoterol fumarate delivered in an Aerosphere metered-dose inhaler (PT009). The other was a combination of 320 μg budesonide and 9 μg formoterol fumarate delivered in a pressurized metered-dose inhaler (Symbicort, AstraZeneca).
The pooled efficacy set included 4,304 patients, of which 1,179 (mean age, 52.4 years; 61.5% female) received Breztri Aerosphere with 28.8 μg glycopyrrolate, 725 (mean age, 51.6 years; 62.2% female) received Breztri Aerosphere with 14.4 μg glycopyrrolate, 1,208 (mean age, 51.7 years; 62.7% female) received Aerosphere and 1,192 (mean age, 52.4 years; 64.7% female) received Symbicort.
After pooling both trials together, Breztri Aerosphere with 28.8 μg glycopyrrolate was favored over combined Aerosphere and Symbicort for change from baseline in morning pre-dose trough FEV1 over 24 weeks (least-squares mean difference: 76 mL; 95% CI, 57-94; P < .0001).
This result was also observed for FEV1 AUC0-3, as Breztri Aerosphere with 28.8 μg glycopyrrolate was favored over combined Aerosphere and Symbicort in the pooled trial analysis (least-square mean difference, 90 mL; 95% CI, 72-108; P < .0001).
In addition to lung function, both trials captured and compared annualized rates of severe exacerbation. In the pooled analysis, patients receiving Breztri Aerosphere with 28.8 μg glycopyrrolate had a significantly lower rate vs. the combined Aerosphere or Symbicort group (incidence rate ratio [IRR] = 0.86; 95% CI, 0.76-0.97) and patients receiving Symbicort (IRR = 0.82; 95% CI, 0.71-0.94).
In terms of safety, the proportion of adverse events was comparable between the groups (Breztri Aerosphere with 28.8 μg glycopyrrolate, 53.2%; Breztri Aerosphere with 14.4 μg glycopyrrolate, 60%; Aerosphere, 55.2%; Symbicort, 58.4%).
There were no treatment-related deaths, according to the study.
“The FDA approval of Breztri as the only maintenance triple therapy for people with asthma 12 years of age and older marks a pivotal moment in helping those living with this debilitating disease breathe better, sooner,” Njira L. Lugogo, MD, clinical professor in the division of pulmonary and critical care medicine at University of Michigan and author on the trials, said in the release.
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