\n<\/p>\n
April 28, 2026<\/p>\n
2 min read<\/p>\n<\/p><\/div>\n
\n \n \n Add topic to email alerts \n <\/span> \n <\/p>\n\n\n \n Receive an email when new articles are posted on \n <\/p>\n\n Please provide your email address to receive an email when new articles are posted on .<\/p><\/div>\n<\/p><\/div>\n “ \n data-action=”subscribe”> \n Subscribe \n <\/button>\n <\/div>\n<\/p><\/div>\n We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.<\/strong> <\/p>\nBack to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\nKey takeaways:<\/h2>\n\nBreztri Aerosphere combines budesonide, glycopyrrolate and formoterol fumarate in one inhaler.<\/li>\nThe FDA based Breztri Aerosphere\u2019s approval on phase 3 KALOS and LOGOS trial results.<\/li>\n<\/ul>\nThe 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.<\/p>\nThe Breztri Aerosphere (AstraZeneca) inhaler combines 320 \u03bcg\u00a0<\/span>budesonide, an inhaled corticosteroid; 36 \u03bcg\u00a0<\/span>glycopyrrolate, a long-acting muscarinic antagonist; and 9.6 \u03bcg\u00a0<\/span>formoterol fumarate, a long-acting beta2-agonist, according to the release.<\/p>\n \n \n \n \n <\/source><\/source><\/source><\/source><\/source><\/picture> \n The FDA based Breztri Aerosphere\u2019s approval on results from two phase 3 trials. \n <\/figcaption> \n <\/figure>\nNotably, Breztri Aerosphere is already FDA approved as a maintenance treatment for patients with COPD.<\/p>\nThe 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. <\/p>\nThe aim of these trials was to determine how treatment with Breztri Aerosphere impacts morning pre-dose trough FEV1<\/sub> over 24 weeks and FEV1<\/sub> area under the curve 0 to 3 hours (AUC0-3<\/sub>) at week 24.<\/p>\nResearchers evaluated two different glycopyrrolate doses \u2014 28.8 \u03bcg\u00a0<\/span>and 14.4 \u03bcg\u00a0<\/span>\u2014 in Breztri Aerosphere in these trials.<\/p>\nBoth trials included two comparator groups. One was a combination of 320 \u03bcg\u00a0<\/span>budesonide and 9.6 \u03bcg\u00a0<\/span>formoterol fumarate delivered in an Aerosphere metered-dose inhaler (PT009). The other was a combination of 320 \u03bcg\u00a0<\/span>budesonide and 9 \u03bcg\u00a0<\/span>formoterol fumarate delivered in a pressurized metered-dose inhaler (Symbicort, AstraZeneca).<\/p>\nThe 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 \u03bcg\u00a0<\/span>glycopyrrolate, 725 (mean age, 51.6 years; 62.2% female) received Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>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. <\/p>\nAfter pooling both trials together, Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort for change from baseline in morning pre-dose trough FEV1<\/sub> over 24 weeks (least-squares mean difference: 76 mL; 95% CI, 57-94; P<\/i> < .0001).<\/p>\nThis result was also observed for FEV1<\/sub> AUC0-3<\/sub>, as Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort in the pooled trial analysis (least-square mean difference, 90 mL; 95% CI, 72-108; P<\/i> < .0001). <\/p>\nIn 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 \u03bcg\u00a0<\/span>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).<\/p>\nIn terms of safety, the proportion of adverse events was comparable between the groups (Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate, 53.2%; Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>glycopyrrolate, 60%; Aerosphere, 55.2%; Symbicort, 58.4%).<\/p>\nThere were no treatment-related deaths, according to the study.<\/p>\n\u201cThe 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,\u201d Njira <\/b>L. <\/b>Lugogo, MD,<\/b> clinical professor in the division of pulmonary and critical care medicine at University of Michigan and author on the trials, said in the release.<\/p>\n
\n Receive an email when new articles are posted on \n <\/p>\n\n Please provide your email address to receive an email when new articles are posted on .<\/p><\/div>\n<\/p><\/div>\n “ \n data-action=”subscribe”> \n Subscribe \n <\/button>\n <\/div>\n<\/p><\/div>\n We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.<\/strong> <\/p>\nBack to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\nKey takeaways:<\/h2>\n\nBreztri Aerosphere combines budesonide, glycopyrrolate and formoterol fumarate in one inhaler.<\/li>\nThe FDA based Breztri Aerosphere\u2019s approval on phase 3 KALOS and LOGOS trial results.<\/li>\n<\/ul>\nThe 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.<\/p>\nThe Breztri Aerosphere (AstraZeneca) inhaler combines 320 \u03bcg\u00a0<\/span>budesonide, an inhaled corticosteroid; 36 \u03bcg\u00a0<\/span>glycopyrrolate, a long-acting muscarinic antagonist; and 9.6 \u03bcg\u00a0<\/span>formoterol fumarate, a long-acting beta2-agonist, according to the release.<\/p>\n \n \n \n \n <\/source><\/source><\/source><\/source><\/source><\/picture> \n The FDA based Breztri Aerosphere\u2019s approval on results from two phase 3 trials. \n <\/figcaption> \n <\/figure>\nNotably, Breztri Aerosphere is already FDA approved as a maintenance treatment for patients with COPD.<\/p>\nThe 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. <\/p>\nThe aim of these trials was to determine how treatment with Breztri Aerosphere impacts morning pre-dose trough FEV1<\/sub> over 24 weeks and FEV1<\/sub> area under the curve 0 to 3 hours (AUC0-3<\/sub>) at week 24.<\/p>\nResearchers evaluated two different glycopyrrolate doses \u2014 28.8 \u03bcg\u00a0<\/span>and 14.4 \u03bcg\u00a0<\/span>\u2014 in Breztri Aerosphere in these trials.<\/p>\nBoth trials included two comparator groups. One was a combination of 320 \u03bcg\u00a0<\/span>budesonide and 9.6 \u03bcg\u00a0<\/span>formoterol fumarate delivered in an Aerosphere metered-dose inhaler (PT009). The other was a combination of 320 \u03bcg\u00a0<\/span>budesonide and 9 \u03bcg\u00a0<\/span>formoterol fumarate delivered in a pressurized metered-dose inhaler (Symbicort, AstraZeneca).<\/p>\nThe 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 \u03bcg\u00a0<\/span>glycopyrrolate, 725 (mean age, 51.6 years; 62.2% female) received Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>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. <\/p>\nAfter pooling both trials together, Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort for change from baseline in morning pre-dose trough FEV1<\/sub> over 24 weeks (least-squares mean difference: 76 mL; 95% CI, 57-94; P<\/i> < .0001).<\/p>\nThis result was also observed for FEV1<\/sub> AUC0-3<\/sub>, as Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort in the pooled trial analysis (least-square mean difference, 90 mL; 95% CI, 72-108; P<\/i> < .0001). <\/p>\nIn 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 \u03bcg\u00a0<\/span>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).<\/p>\nIn terms of safety, the proportion of adverse events was comparable between the groups (Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate, 53.2%; Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>glycopyrrolate, 60%; Aerosphere, 55.2%; Symbicort, 58.4%).<\/p>\nThere were no treatment-related deaths, according to the study.<\/p>\n\u201cThe 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,\u201d Njira <\/b>L. <\/b>Lugogo, MD,<\/b> clinical professor in the division of pulmonary and critical care medicine at University of Michigan and author on the trials, said in the release.<\/p>\n
“ \n data-action=”subscribe”> \n Subscribe \n <\/button>\n <\/div>\n<\/p><\/div>\n We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.<\/strong> <\/p>\nBack to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\nKey takeaways:<\/h2>\n\nBreztri Aerosphere combines budesonide, glycopyrrolate and formoterol fumarate in one inhaler.<\/li>\nThe FDA based Breztri Aerosphere\u2019s approval on phase 3 KALOS and LOGOS trial results.<\/li>\n<\/ul>\nThe 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.<\/p>\nThe Breztri Aerosphere (AstraZeneca) inhaler combines 320 \u03bcg\u00a0<\/span>budesonide, an inhaled corticosteroid; 36 \u03bcg\u00a0<\/span>glycopyrrolate, a long-acting muscarinic antagonist; and 9.6 \u03bcg\u00a0<\/span>formoterol fumarate, a long-acting beta2-agonist, according to the release.<\/p>\n \n \n \n \n <\/source><\/source><\/source><\/source><\/source><\/picture> \n The FDA based Breztri Aerosphere\u2019s approval on results from two phase 3 trials. \n <\/figcaption> \n <\/figure>\nNotably, Breztri Aerosphere is already FDA approved as a maintenance treatment for patients with COPD.<\/p>\nThe 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. <\/p>\nThe aim of these trials was to determine how treatment with Breztri Aerosphere impacts morning pre-dose trough FEV1<\/sub> over 24 weeks and FEV1<\/sub> area under the curve 0 to 3 hours (AUC0-3<\/sub>) at week 24.<\/p>\nResearchers evaluated two different glycopyrrolate doses \u2014 28.8 \u03bcg\u00a0<\/span>and 14.4 \u03bcg\u00a0<\/span>\u2014 in Breztri Aerosphere in these trials.<\/p>\nBoth trials included two comparator groups. One was a combination of 320 \u03bcg\u00a0<\/span>budesonide and 9.6 \u03bcg\u00a0<\/span>formoterol fumarate delivered in an Aerosphere metered-dose inhaler (PT009). The other was a combination of 320 \u03bcg\u00a0<\/span>budesonide and 9 \u03bcg\u00a0<\/span>formoterol fumarate delivered in a pressurized metered-dose inhaler (Symbicort, AstraZeneca).<\/p>\nThe 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 \u03bcg\u00a0<\/span>glycopyrrolate, 725 (mean age, 51.6 years; 62.2% female) received Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>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. <\/p>\nAfter pooling both trials together, Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort for change from baseline in morning pre-dose trough FEV1<\/sub> over 24 weeks (least-squares mean difference: 76 mL; 95% CI, 57-94; P<\/i> < .0001).<\/p>\nThis result was also observed for FEV1<\/sub> AUC0-3<\/sub>, as Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort in the pooled trial analysis (least-square mean difference, 90 mL; 95% CI, 72-108; P<\/i> < .0001). <\/p>\nIn 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 \u03bcg\u00a0<\/span>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).<\/p>\nIn terms of safety, the proportion of adverse events was comparable between the groups (Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate, 53.2%; Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>glycopyrrolate, 60%; Aerosphere, 55.2%; Symbicort, 58.4%).<\/p>\nThere were no treatment-related deaths, according to the study.<\/p>\n\u201cThe 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,\u201d Njira <\/b>L. <\/b>Lugogo, MD,<\/b> clinical professor in the division of pulmonary and critical care medicine at University of Michigan and author on the trials, said in the release.<\/p>\n
Back to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\nKey takeaways:<\/h2>\n\nBreztri Aerosphere combines budesonide, glycopyrrolate and formoterol fumarate in one inhaler.<\/li>\nThe FDA based Breztri Aerosphere\u2019s approval on phase 3 KALOS and LOGOS trial results.<\/li>\n<\/ul>\nThe 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.<\/p>\nThe Breztri Aerosphere (AstraZeneca) inhaler combines 320 \u03bcg\u00a0<\/span>budesonide, an inhaled corticosteroid; 36 \u03bcg\u00a0<\/span>glycopyrrolate, a long-acting muscarinic antagonist; and 9.6 \u03bcg\u00a0<\/span>formoterol fumarate, a long-acting beta2-agonist, according to the release.<\/p>\n \n \n \n \n <\/source><\/source><\/source><\/source><\/source><\/picture> \n The FDA based Breztri Aerosphere\u2019s approval on results from two phase 3 trials. \n <\/figcaption> \n <\/figure>\nNotably, Breztri Aerosphere is already FDA approved as a maintenance treatment for patients with COPD.<\/p>\nThe 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. <\/p>\nThe aim of these trials was to determine how treatment with Breztri Aerosphere impacts morning pre-dose trough FEV1<\/sub> over 24 weeks and FEV1<\/sub> area under the curve 0 to 3 hours (AUC0-3<\/sub>) at week 24.<\/p>\nResearchers evaluated two different glycopyrrolate doses \u2014 28.8 \u03bcg\u00a0<\/span>and 14.4 \u03bcg\u00a0<\/span>\u2014 in Breztri Aerosphere in these trials.<\/p>\nBoth trials included two comparator groups. One was a combination of 320 \u03bcg\u00a0<\/span>budesonide and 9.6 \u03bcg\u00a0<\/span>formoterol fumarate delivered in an Aerosphere metered-dose inhaler (PT009). The other was a combination of 320 \u03bcg\u00a0<\/span>budesonide and 9 \u03bcg\u00a0<\/span>formoterol fumarate delivered in a pressurized metered-dose inhaler (Symbicort, AstraZeneca).<\/p>\nThe 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 \u03bcg\u00a0<\/span>glycopyrrolate, 725 (mean age, 51.6 years; 62.2% female) received Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>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. <\/p>\nAfter pooling both trials together, Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort for change from baseline in morning pre-dose trough FEV1<\/sub> over 24 weeks (least-squares mean difference: 76 mL; 95% CI, 57-94; P<\/i> < .0001).<\/p>\nThis result was also observed for FEV1<\/sub> AUC0-3<\/sub>, as Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort in the pooled trial analysis (least-square mean difference, 90 mL; 95% CI, 72-108; P<\/i> < .0001). <\/p>\nIn 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 \u03bcg\u00a0<\/span>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).<\/p>\nIn terms of safety, the proportion of adverse events was comparable between the groups (Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate, 53.2%; Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>glycopyrrolate, 60%; Aerosphere, 55.2%; Symbicort, 58.4%).<\/p>\nThere were no treatment-related deaths, according to the study.<\/p>\n\u201cThe 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,\u201d Njira <\/b>L. <\/b>Lugogo, MD,<\/b> clinical professor in the division of pulmonary and critical care medicine at University of Michigan and author on the trials, said in the release.<\/p>\n
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.<\/p>\n
The Breztri Aerosphere (AstraZeneca) inhaler combines 320 \u03bcg\u00a0<\/span>budesonide, an inhaled corticosteroid; 36 \u03bcg\u00a0<\/span>glycopyrrolate, a long-acting muscarinic antagonist; and 9.6 \u03bcg\u00a0<\/span>formoterol fumarate, a long-acting beta2-agonist, according to the release.<\/p>\n \n \n \n \n <\/source><\/source><\/source><\/source><\/source><\/picture> \n The FDA based Breztri Aerosphere\u2019s approval on results from two phase 3 trials. \n <\/figcaption> \n <\/figure>\nNotably, Breztri Aerosphere is already FDA approved as a maintenance treatment for patients with COPD.<\/p>\nThe 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. <\/p>\nThe aim of these trials was to determine how treatment with Breztri Aerosphere impacts morning pre-dose trough FEV1<\/sub> over 24 weeks and FEV1<\/sub> area under the curve 0 to 3 hours (AUC0-3<\/sub>) at week 24.<\/p>\nResearchers evaluated two different glycopyrrolate doses \u2014 28.8 \u03bcg\u00a0<\/span>and 14.4 \u03bcg\u00a0<\/span>\u2014 in Breztri Aerosphere in these trials.<\/p>\nBoth trials included two comparator groups. One was a combination of 320 \u03bcg\u00a0<\/span>budesonide and 9.6 \u03bcg\u00a0<\/span>formoterol fumarate delivered in an Aerosphere metered-dose inhaler (PT009). The other was a combination of 320 \u03bcg\u00a0<\/span>budesonide and 9 \u03bcg\u00a0<\/span>formoterol fumarate delivered in a pressurized metered-dose inhaler (Symbicort, AstraZeneca).<\/p>\nThe 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 \u03bcg\u00a0<\/span>glycopyrrolate, 725 (mean age, 51.6 years; 62.2% female) received Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>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. <\/p>\nAfter pooling both trials together, Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort for change from baseline in morning pre-dose trough FEV1<\/sub> over 24 weeks (least-squares mean difference: 76 mL; 95% CI, 57-94; P<\/i> < .0001).<\/p>\nThis result was also observed for FEV1<\/sub> AUC0-3<\/sub>, as Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort in the pooled trial analysis (least-square mean difference, 90 mL; 95% CI, 72-108; P<\/i> < .0001). <\/p>\nIn 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 \u03bcg\u00a0<\/span>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).<\/p>\nIn terms of safety, the proportion of adverse events was comparable between the groups (Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate, 53.2%; Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>glycopyrrolate, 60%; Aerosphere, 55.2%; Symbicort, 58.4%).<\/p>\nThere were no treatment-related deaths, according to the study.<\/p>\n\u201cThe 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,\u201d Njira <\/b>L. <\/b>Lugogo, MD,<\/b> clinical professor in the division of pulmonary and critical care medicine at University of Michigan and author on the trials, said in the release.<\/p>\n
Notably, Breztri Aerosphere is already FDA approved as a maintenance treatment for patients with COPD.<\/p>\n
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. <\/p>\n
The aim of these trials was to determine how treatment with Breztri Aerosphere impacts morning pre-dose trough FEV1<\/sub> over 24 weeks and FEV1<\/sub> area under the curve 0 to 3 hours (AUC0-3<\/sub>) at week 24.<\/p>\nResearchers evaluated two different glycopyrrolate doses \u2014 28.8 \u03bcg\u00a0<\/span>and 14.4 \u03bcg\u00a0<\/span>\u2014 in Breztri Aerosphere in these trials.<\/p>\nBoth trials included two comparator groups. One was a combination of 320 \u03bcg\u00a0<\/span>budesonide and 9.6 \u03bcg\u00a0<\/span>formoterol fumarate delivered in an Aerosphere metered-dose inhaler (PT009). The other was a combination of 320 \u03bcg\u00a0<\/span>budesonide and 9 \u03bcg\u00a0<\/span>formoterol fumarate delivered in a pressurized metered-dose inhaler (Symbicort, AstraZeneca).<\/p>\nThe 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 \u03bcg\u00a0<\/span>glycopyrrolate, 725 (mean age, 51.6 years; 62.2% female) received Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>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. <\/p>\nAfter pooling both trials together, Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort for change from baseline in morning pre-dose trough FEV1<\/sub> over 24 weeks (least-squares mean difference: 76 mL; 95% CI, 57-94; P<\/i> < .0001).<\/p>\nThis result was also observed for FEV1<\/sub> AUC0-3<\/sub>, as Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort in the pooled trial analysis (least-square mean difference, 90 mL; 95% CI, 72-108; P<\/i> < .0001). <\/p>\nIn 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 \u03bcg\u00a0<\/span>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).<\/p>\nIn terms of safety, the proportion of adverse events was comparable between the groups (Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate, 53.2%; Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>glycopyrrolate, 60%; Aerosphere, 55.2%; Symbicort, 58.4%).<\/p>\nThere were no treatment-related deaths, according to the study.<\/p>\n\u201cThe 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,\u201d Njira <\/b>L. <\/b>Lugogo, MD,<\/b> clinical professor in the division of pulmonary and critical care medicine at University of Michigan and author on the trials, said in the release.<\/p>\n
Researchers evaluated two different glycopyrrolate doses \u2014 28.8 \u03bcg\u00a0<\/span>and 14.4 \u03bcg\u00a0<\/span>\u2014 in Breztri Aerosphere in these trials.<\/p>\nBoth trials included two comparator groups. One was a combination of 320 \u03bcg\u00a0<\/span>budesonide and 9.6 \u03bcg\u00a0<\/span>formoterol fumarate delivered in an Aerosphere metered-dose inhaler (PT009). The other was a combination of 320 \u03bcg\u00a0<\/span>budesonide and 9 \u03bcg\u00a0<\/span>formoterol fumarate delivered in a pressurized metered-dose inhaler (Symbicort, AstraZeneca).<\/p>\nThe 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 \u03bcg\u00a0<\/span>glycopyrrolate, 725 (mean age, 51.6 years; 62.2% female) received Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>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. <\/p>\nAfter pooling both trials together, Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort for change from baseline in morning pre-dose trough FEV1<\/sub> over 24 weeks (least-squares mean difference: 76 mL; 95% CI, 57-94; P<\/i> < .0001).<\/p>\nThis result was also observed for FEV1<\/sub> AUC0-3<\/sub>, as Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort in the pooled trial analysis (least-square mean difference, 90 mL; 95% CI, 72-108; P<\/i> < .0001). <\/p>\nIn 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 \u03bcg\u00a0<\/span>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).<\/p>\nIn terms of safety, the proportion of adverse events was comparable between the groups (Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate, 53.2%; Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>glycopyrrolate, 60%; Aerosphere, 55.2%; Symbicort, 58.4%).<\/p>\nThere were no treatment-related deaths, according to the study.<\/p>\n\u201cThe 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,\u201d Njira <\/b>L. <\/b>Lugogo, MD,<\/b> clinical professor in the division of pulmonary and critical care medicine at University of Michigan and author on the trials, said in the release.<\/p>\n
Both trials included two comparator groups. One was a combination of 320 \u03bcg\u00a0<\/span>budesonide and 9.6 \u03bcg\u00a0<\/span>formoterol fumarate delivered in an Aerosphere metered-dose inhaler (PT009). The other was a combination of 320 \u03bcg\u00a0<\/span>budesonide and 9 \u03bcg\u00a0<\/span>formoterol fumarate delivered in a pressurized metered-dose inhaler (Symbicort, AstraZeneca).<\/p>\nThe 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 \u03bcg\u00a0<\/span>glycopyrrolate, 725 (mean age, 51.6 years; 62.2% female) received Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>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. <\/p>\nAfter pooling both trials together, Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort for change from baseline in morning pre-dose trough FEV1<\/sub> over 24 weeks (least-squares mean difference: 76 mL; 95% CI, 57-94; P<\/i> < .0001).<\/p>\nThis result was also observed for FEV1<\/sub> AUC0-3<\/sub>, as Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort in the pooled trial analysis (least-square mean difference, 90 mL; 95% CI, 72-108; P<\/i> < .0001). <\/p>\nIn 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 \u03bcg\u00a0<\/span>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).<\/p>\nIn terms of safety, the proportion of adverse events was comparable between the groups (Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate, 53.2%; Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>glycopyrrolate, 60%; Aerosphere, 55.2%; Symbicort, 58.4%).<\/p>\nThere were no treatment-related deaths, according to the study.<\/p>\n\u201cThe 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,\u201d Njira <\/b>L. <\/b>Lugogo, MD,<\/b> clinical professor in the division of pulmonary and critical care medicine at University of Michigan and author on the trials, said in the release.<\/p>\n
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 \u03bcg\u00a0<\/span>glycopyrrolate, 725 (mean age, 51.6 years; 62.2% female) received Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>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. <\/p>\nAfter pooling both trials together, Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort for change from baseline in morning pre-dose trough FEV1<\/sub> over 24 weeks (least-squares mean difference: 76 mL; 95% CI, 57-94; P<\/i> < .0001).<\/p>\nThis result was also observed for FEV1<\/sub> AUC0-3<\/sub>, as Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort in the pooled trial analysis (least-square mean difference, 90 mL; 95% CI, 72-108; P<\/i> < .0001). <\/p>\nIn 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 \u03bcg\u00a0<\/span>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).<\/p>\nIn terms of safety, the proportion of adverse events was comparable between the groups (Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate, 53.2%; Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>glycopyrrolate, 60%; Aerosphere, 55.2%; Symbicort, 58.4%).<\/p>\nThere were no treatment-related deaths, according to the study.<\/p>\n\u201cThe 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,\u201d Njira <\/b>L. <\/b>Lugogo, MD,<\/b> clinical professor in the division of pulmonary and critical care medicine at University of Michigan and author on the trials, said in the release.<\/p>\n
After pooling both trials together, Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort for change from baseline in morning pre-dose trough FEV1<\/sub> over 24 weeks (least-squares mean difference: 76 mL; 95% CI, 57-94; P<\/i> < .0001).<\/p>\nThis result was also observed for FEV1<\/sub> AUC0-3<\/sub>, as Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort in the pooled trial analysis (least-square mean difference, 90 mL; 95% CI, 72-108; P<\/i> < .0001). <\/p>\nIn 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 \u03bcg\u00a0<\/span>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).<\/p>\nIn terms of safety, the proportion of adverse events was comparable between the groups (Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate, 53.2%; Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>glycopyrrolate, 60%; Aerosphere, 55.2%; Symbicort, 58.4%).<\/p>\nThere were no treatment-related deaths, according to the study.<\/p>\n\u201cThe 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,\u201d Njira <\/b>L. <\/b>Lugogo, MD,<\/b> clinical professor in the division of pulmonary and critical care medicine at University of Michigan and author on the trials, said in the release.<\/p>\n
This result was also observed for FEV1<\/sub> AUC0-3<\/sub>, as Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate was favored over combined Aerosphere and Symbicort in the pooled trial analysis (least-square mean difference, 90 mL; 95% CI, 72-108; P<\/i> < .0001). <\/p>\nIn 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 \u03bcg\u00a0<\/span>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).<\/p>\nIn terms of safety, the proportion of adverse events was comparable between the groups (Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate, 53.2%; Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>glycopyrrolate, 60%; Aerosphere, 55.2%; Symbicort, 58.4%).<\/p>\nThere were no treatment-related deaths, according to the study.<\/p>\n\u201cThe 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,\u201d Njira <\/b>L. <\/b>Lugogo, MD,<\/b> clinical professor in the division of pulmonary and critical care medicine at University of Michigan and author on the trials, said in the release.<\/p>\n
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 \u03bcg\u00a0<\/span>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).<\/p>\nIn terms of safety, the proportion of adverse events was comparable between the groups (Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate, 53.2%; Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>glycopyrrolate, 60%; Aerosphere, 55.2%; Symbicort, 58.4%).<\/p>\nThere were no treatment-related deaths, according to the study.<\/p>\n\u201cThe 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,\u201d Njira <\/b>L. <\/b>Lugogo, MD,<\/b> clinical professor in the division of pulmonary and critical care medicine at University of Michigan and author on the trials, said in the release.<\/p>\n
In terms of safety, the proportion of adverse events was comparable between the groups (Breztri Aerosphere with 28.8 \u03bcg\u00a0<\/span>glycopyrrolate, 53.2%; Breztri Aerosphere with 14.4 \u03bcg\u00a0<\/span>glycopyrrolate, 60%; Aerosphere, 55.2%; Symbicort, 58.4%).<\/p>\nThere were no treatment-related deaths, according to the study.<\/p>\n\u201cThe 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,\u201d Njira <\/b>L. <\/b>Lugogo, MD,<\/b> clinical professor in the division of pulmonary and critical care medicine at University of Michigan and author on the trials, said in the release.<\/p>\n
There were no treatment-related deaths, according to the study.<\/p>\n
\u201cThe 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,\u201d Njira <\/b>L. <\/b>Lugogo, MD,<\/b> clinical professor in the division of pulmonary and critical care medicine at University of Michigan and author on the trials, said in the release.<\/p>\n