![]() For the comparison with a LAMA plus a LABA, it is approximately one fewer moderate exacerbation every 2.5 years. In comparison with the inhaled corticosteroid plus LABA combination, that is approximately one fewer moderate or severe exacerbation every four years, but because there was no reduction in severe exacerbations, this is due to fewer moderate exacerbations. There was a difference in the likelihood of moderate to severe exacerbations: 1.25 and 1.23 per year in the 320-mcg and 160-mcg triple therapy groups, respectively, compared with 1.63 in the LAMA plus LABA group, and 1.47 in the inhaled corticosteroid plus LABA group. ![]() After one year, there was no clinically significant difference between groups in the rate of severe exacerbations (0.13 to 0.16 per year in the four groups). It is unclear why rates of exacerbation were analyzed by means of negative binomial regression instead of a straightforward comparison of the rates of the primary outcome between groups. ![]() Groups were balanced at baseline, but allocation concealment was not described. The primary outcome was the rate of moderate or severe exacerbations severe involved hospitalization, whereas moderate was any exacerbation treated with three or more days of an antibiotic or systemic corticosteroid. Approximately 30% of participants had a postbronchodilator FEV 1 of 50% to 80% of predicted, 60% were at 30% to 50% of predicted, and 10% were less than 30% of predicted. Participants had a mean age of 64 years, approximately 60% were men, and 41% were current smokers. Participants had COPD that was not well-controlled (forced expiratory volume in one second less than 0.70 postbronchodilator, and already taking at least two inhaled agents) and had experienced at least one moderate or severe exacerbation in the past year. The study randomized 8,588 patients to one of four regimens: triple therapy with 320 mcg of budesonide daily, triple therapy with budesonide, 160 mcg daily, dual therapy with a LAMA plus a LABA, and dual therapy with an inhaled corticosteroid plus a LABA. The inhaled corticosteroid in this study was budesonide, the LAMA was glycopyrrolate, 9 mcg twice daily, and the LABA was formoterol (Breztri Aerosphere), 4.8 mcg twice daily. Triple inhaled therapy for COPD consists of an inhaled corticosteroid, a LAMA, and a LABA.
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