BREZTRI significantly reduced the annual rate of moderate or severe COPD exacerbations vs LAMA/LABA (RR=0.76; 95% CI: 0.69, 0.83; P<0.0001) and ICS/LABA (RR=0.87; 95% CI: 0.79, 0.95; P=0.0027) in a 52-week study.1†‡ Annual rate estimate: BREZTRI 1.08; LAMA/LABA 1.42; ICS/LABA 1.24.1
In a 52-week study in patients with ≥1 exacerbation within the last year,†
THE ONLY TRIPLE THERAPY§ VS ICS/LABA TO SHOW A SIGNIFICANT REDUCTION IN COPD HOSPITALIZATIONS2,4,5*
*Hospitalization for a severe COPD exacerbation.‡
REDUCTION VS ICS/LABA2,4
(rate ratio=0.80; 95% CI: 0.66, 0.97; P=0.02)2ǁ
STUDY 1
Reduction in severe exacerbations2‡
16% reduction vs LAMA/LABA (rate ratio=0.84; 95% CI: 0.69, 1.03; P=0.09)2
Annual rate estimate: BREZTRI 0.13 (n=2137); ICS/LABA 0.16 (n=2131); LAMA/LABA 0.15 (n=2120).2
Significant reduction in moderate or severe exacerbations‡
24% reduction vs LAMA/LABA (rate ratio=0.76; 95% CI: 0.69, 0.83; P<0.0001)
13% reduction vs ICS/LABA (rate ratio=0.87; 95% CI: 0.79, 0.95; P=0.0027)
Annual rate estimate: BREZTRI 1.08 (n=2137); LAMA/LABA 1.42 (n=2120); ICS/LABA 1.24 (n=2131).
†Study 1: Patients (N=8588) with ≥1 moderate or severe exacerbation(s) in the year prior to screening.
BREZTRI is administered as 2 inhalations twice daily.
‡Moderate exacerbations were defined as those leading to treatment with systemic corticosteroids and/or antibiotics, and severe exacerbations were defined as those resulting in hospitalization or death.
§Fixed-dose combination: ICS/LAMA/LABA.
ǁBased on predefined Type-1 error control plan.
RR=rate ratio.
BREZTRI demonstrated a significant improvement in FEV1 AUC0-4 vs ICS/LABA (116 mL; P<0.0001) and an improvement in mean change from baseline in morning pre-dose trough FEV1 vs LAMA/LABA (13 mL; P=0.2375) in a 24-week study.1,3
In a 24-week study where the majority of patients did not have a history of exacerbations within the last year,6*
THE ONLY TRIPLE THERAPY† VS LAMA/LABA TO PREVENT MODERATE OR SEVERE EXACERBATIONS1,3,5‡
REDUCTION VS LAMA/LABA1,3
(rate ratio=0.48; 95% CI: 0.37, 0.64; unadjusted P<0.0001)1,3§
STUDY 2
Reduction in moderate or severe exacerbations1,3‡
18% reduction vs ICS/LABA (rate ratio=0.82; 95% CI: 0.58, 1.17; P=0.2792)1,3
Annual rate estimate: BREZTRI 0.46 (n=639); ICS/LABA 0.56 (n=314); LAMA/LABA 0.95 (n=625).3
Difference in severe exacerbationsǁ (other endpoint)7‡
BREZTRI vs LAMA/LABA (rate ratio=0.36; 95% CI: 0.18, 0.70)
BREZTRI vs ICS/LABA (rate ratio=0.85; 95% CI: 0.34, 2.13)
Annual rate estimate: BREZTRI 0.05 (n=639); ICS/LABA 0.05 (n=314); LAMA/LABA 0.13 (n=625).
*Study 2: Patients (N=1896) were not required to have a history of moderate or severe exacerbations in the year prior to screening.
BREZTRI is administered as 2 inhalations twice daily.
†Fixed-dose combination: ICS/LAMA/LABA.
‡Moderate exacerbations were defined as those leading to treatment with systemic corticosteroids and/or antibiotics, and severe exacerbations were defined as those resulting in hospitalization or death.
§P value is considered unadjusted due to nonsignificant results higher in the testing hierarchy.
ǁResults are descriptive only.
BREZTRI IS THE ONLY TRIPLE THERAPY* THAT CONTAINS BUDESONIDE1,5
*Fixed-dose combination: ICS/LAMA/LABA.
Study 1 Design1,2
Study 1 was a 52-week, Phase 3, randomized, double-blind, parallel-group, multicenter study of 8588 patients with moderate to very severe COPD that compared BREZTRI MDI 320/18/9.6 (n=2157) with budesonide/glycopyrrolate/formoterol fumarate MDI 160/18/9.6 (n=2137), glycopyrrolate/formoterol fumarate MDI 18/9.6 (n=2143), and budesonide/formoterol fumarate MDI 320/9.6 (n=2151), each administered twice daily. Patients were current or former smokers with a smoking history of ≥10 pack-years, aged 40-80 years, with symptomatic COPD despite receiving 2 or more inhaled maintenance therapies, and a history of ≥1 moderate or severe exacerbation(s) in the previous year. The primary endpoint was the estimated annual rate of moderate or severe COPD exacerbations. Secondary endpoints included the estimated annual rate of severe COPD exacerbations and time to all-cause mortality over 52 weeks.
MDI=metered-dose inhaler; BID=twice daily.
Study 2 Design1,3,6,7
Study 2 was a 24-week, Phase 3, randomized, double-blind, parallel-group, multicenter study of 1896 patients with moderate to very severe COPD that compared BREZTRI MDI 320/18/9.6 (n=639) with glycopyrrolate/formoterol fumarate MDI 18/9.6 (n=625), budesonide/formoterol fumarate MDI 320/9.6 (n=314), and budesonide/formoterol fumarate DPI 400/12 (n=318), each administered twice daily. Patients were current or former smokers with a smoking history of ≥10 pack-years, aged 40-80 years, with symptomatic COPD despite receiving 2 or more inhaled maintenance therapies. Patients were not required to have a history of moderate or severe exacerbations in the previous year. The primary endpoints were FEV1 area under the curve from 0-4 hours (FEV1 AUC0-4) at Week 24 for BREZTRI compared to budesonide/formoterol fumarate and change from baseline in morning pre-dose trough FEV1 at Week 24 for BREZTRI compared to glycopyrrolate/formoterol fumarate MDI. Secondary endpoints included the rate of moderate or severe COPD exacerbations and other endpoints included the rate of severe exacerbations.
DPI=dry powder inhaler; MDI=metered-dose inhaler.