LUNG FUNCTION
BREO– the only ICS/LABAthat provides 24-hour-lasting lung function improvement without a second daily dose, starting in 15 minutes*
*Median time to onset (100-mL increase from baseline in mean FEV1) was 15 minutes after beginning treatment.
SEE LUNG FUNCTION VIDEOBREO 100/25
In a 12-week study in patients who were symptomatic on mid- to high-dose ICS
BREO 100/25 (n=312) provided a statistically significant 108-mL (30%) improvement in least squares mean change from baseline in wm FEV1 (0‑24 hours) compared with FF100 mcg (n=288) (P<0.001) at Week 12.
SERIAL FEV1 (0-24 HOURS) AT WEEK 12


In a placebo-controlled 12-week study:
- wm FEV1: in a subset of patients, BREO 100/25 (n=108) demonstrated a numerically greater improvement in change from baseline in wm FEV1 (0-24 hours) compared with FF 100 mcg (n=106) of 116 mL (95% Cl: -5, 236; P=0.06) and a statistically significant 302-mL improvement (P<0.001) compared with placebo (n=95) at Week 12
- Trough FEV1: there was a numerically greater change from baseline in trough FEV1 for BREO 100/25 (n=200) compared with FF 100 mcg (n=203) of 36 mL (95% Cl: -48, 120; P=0.405) and a statistically significant 172-mL improvement (P<0.001) compared with placebo (n=193) at Week 12
Study Descriptions
12-week study: Patients who were symptomatic on a mid- to high-dose ICS
Design: 12-week, randomized, double-blind study that evaluated the safety and efficacy of BREO 100/25, BREO 200/25, and fluticasone furoate (FF) 100 mcg (each administered once daily in the evening). Patients who reported symptoms and/or rescue beta2‑agonist use during a 4-week run-in period on mid- to high-dose ICS (≥250 mcg fluticasone propionate [FP] twice daily or equivalent) were randomized to treatment.
Patients: 1039 patients with asthma aged 12 years and older* (mean age: 46 years). At baseline, patients had a mean percent predicted FEV1 of 62%.
*BREO is approved for use in patients ≥18 years of age.
Primary endpoint: wm FEV1 (0-24 hours) at week 12.
Secondary endpoint: trough FEV1 at week 12.
Placebo-controlled 12-week study: Patients who were symptomatic on a low- to mid-dose ICS
Design: 12-week, randomized, double-blind, placebo-controlled study of 609 patients aged 12 years and older* (mean age: 40 years) with asthma, symptomatic on low- to mid-dose ICS (FP 100 mcg to 250 mcg twice daily or equivalent) during a 4-week run-in period (mean baseline percent predicted FEV1 of 70%) randomized to BREO 100/25, FF 100 mcg, or placebo (each administered once daily in the evening).
*BREO is approved for use in patients ≥18 years of age.
Co-primary endpoints: wm FEV1 (0-24 hours) (in a subset of patients) and trough FEV1 at week 12.
CHANGE FROM BASELINE IN TROUGH FEV1 AT WEEK 12
Treatment | n | Difference from FF 100 mcg (n=336) |
---|---|---|
BREO 100/25 | 334 | 77 mL (P=0.014) |
12-week study: Patients who were symptomatic on a mid- to high-dose ICS
Design: 12-week, randomized, double-blind study that evaluated the safety and efficacy of BREO 100/25, BREO 200/25, and fluticasone furoate (FF) 100 mcg (each administered once daily in the evening). Patients who reported symptoms and/or rescue beta2‑agonist use during a 4-week run-in period on mid- to high-dose ICS (≥250 mcg fluticasone propionate [FP] twice daily or equivalent) were randomized to treatment.
Patients: 1039 patients with asthma aged 12 years and older* (mean age: 46 years). At baseline, patients had a mean percent predicted FEV1 of 62%.
*BREO is approved for use in patients ≥18 years of age.
Primary endpoint: wm FEV1 (0-24 hours) at week 12.
Secondary endpoint: trough FEV1 at week 12.
BREO 200/25
In a 24-week study in patients who were symptomatic on mid- to high-dose ICS
In a subset of patients, BREO 200/25 (n=89) provided a statistically significant 136 mL (41%) improvement in least squares change from baseline in wm FEV1 (0-24 hours) compared with FF 200 mcg (n=83) (P=0.048) at Week 24.
SERIAL FEV1 (0-24 HOURS) AT WEEK 24 IN A SUBSET OF PATIENTS


24-week study: Patients who were symptomatic on a mid- to high-dose ICS
Design: 24-week, randomized, double-blind, double-dummy, active control study that evaluated the safety and efficacy of BREO 200/25 and FF 200 mcg (each administered once daily in the evening). Patients who reported symptoms and/or rescue beta2‑agonist use during a 4-week run-in period on mid- to high-dose ICS (≥250 mcg fluticasone propionate [FP] twice daily or equivalent) were randomized to treatment.
Patients: 586 patients with asthma aged 12 years and older* (mean age: 46 years). At baseline, patients had a mean percent predicted FEV1 of 67%.
*BREO is approved for use in patients ≥18 years of age.
Co-primary endpoints: wm FEV1 (0-24 hours) (calculated in a subset of patients performing serial FEV1 at the end of 24 weeks) and trough FEV1 at the end of the 24-week treatment period.
CHANGE FROM BASELINE IN TROUGH FEV1 AT WEEK 24
Treatment | n | Difference from FF 200 mcg (n=186) |
---|---|---|
BREO 200/25 | 187 | 193 mL (P<0.001) |
24-week study: Patients who were symptomatic on a mid- to high-dose ICS
Design: 24-week, randomized, double-blind, double-dummy, active control study that evaluated the safety and efficacy of BREO 200/25 and FF 200 mcg (each administered once daily in the evening). Patients who reported symptoms and/or rescue beta2‑agonist use during a 4-week run-in period on mid- to high-dose ICS (≥250 mcg fluticasone propionate [FP] twice daily or equivalent) were randomized to treatment.
Patients: 586 patients with asthma aged 12 years and older* (mean age: 46 years). At baseline, patients had a mean percent predicted FEV1 of 67%.
*BREO is approved for use in patients ≥18 years of age.
Co-primary endpoints: wm FEV1 (0-24 hours) (calculated in a subset of patients performing serial FEV1 at the end of 24 weeks) and trough FEV1 at the end of the 24-week treatment period.