BREO is for adult patients with asthma uncontrolled on a long-term control medication (eg, ICS) or whose disease warrants an ICS/LABA (inhaled corticosteroid/long-acting beta2-adrenergic agonist). BREO is NOT indicated for the relief of acute bronchospasm.
In patients uncontrolled on an ICS alone, BREO has been proven to:
Deliver 24-hour lung
function improvement with
one inhalation, once daily*
Increase days without
asthma symptoms and
increase days without use
of rescue medication†
Reduce asthma exacerbations
in patients with a history of
Supporting Clinical Study Information
|*||In a randomized, double-blind (RDB) study of 1039 patients§ symptomatic on a mid- to high-dose ICS, BREO 100/25 once daily (n=312) demonstrated a 108-mL improvement from baseline in weighted mean (wm) FEV1 (0-24 hours) at the end of the 12-week treatment period vs fluticasone furoate (FF) 100 mcg once daily (n=288) (P<0.001)."scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50" (In an RDB, placebo-controlled study of 609 patients§ symptomatic on a low- to mid-dose ICS, in a subset of patients, BREO 100/25 once daily [n=108] demonstrated a change from baseline in wm FEV1 [0-24 hours] at the end of the 12-week treatment period vs FF 100 mcg once daily [n=106] of 116 mL [95% CI: –5, 236; P=0.06]."scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50")|
|†||In an RDB study of 1039 patients§ symptomatic on a mid- to high-dose ICS, BREO 100/25 once daily (n=345) provided an increase from baseline in the percent of rescue-free and the percent of symptom-free 24-hour periods during the 12-week treatment period of 12.2% and 7.8%, respectively (P≤0.002), vs FF 100 mcg once daily (n=346)."scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"|
|‡||In a 24- to 76-week RDB study of 2019 patients§ with ≥1 exacerbations in the prior year, BREO 100/25 once daily (n=1009) reduced the risk of experiencing an exacerbation by 20% (Hazard Ratio=0.795, P=0.036) vs FF 100 mcg once daily (n=1010). An exacerbation was defined as a deterioration of asthma requiring the use of systemic corticosteroids (SCS) for ≥3 days or an in-patient hospitalization or emergency department visit due to asthma that required SCS.|
|§||Studies included patients with asthma ≥12 years of age; BREO is only approved for use in patients ≥18 years of age.|
BREO is indicated for the once-daily treatment of asthma in patients aged 18 years and older. BREO should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2-adrenergic agonist (LABA).
BREO is NOT indicated for the relief of acute bronchospasm.
WARNINGS AND PRECAUTIONS
USE IN SPECIFIC POPULATIONS
BREO was developed in collaboration with
826239R0 January 2018