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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.


Lasting lung function improvement for a full
24 hours, starting in 15 minutes*

*Median time to onset (100-mL increase from baseline in mean FEV1) was 15 minutes after beginning treatment.

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 FF (fluticasone furoate) 100 mcg (n=288) (P<0.001) at Week 12.1

In a placebo-controlled 12-week study2:

  • 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% CI: -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% CI: -48, 120; P=0.405) and a statistically significant 172-mL improvement (P<0.001) compared with placebo (n=193) at Week 12

CI=confidence interval; FEV1=forced expiratory volume in 1 second; ICS=inhaled corticosteroid; wm=weighted mean.


BREO – 24-hour lasting symptom control
without a second daily dose.

Based on a 12-week study of patients who remained symptomatic* on a mid- to high-dose ICS, BREO provided:

FF=fluticasone furoate; ICS=inhaled corticosteroid.

FF=fluticasone furoate; ICS=inhaled corticosteroid.


Proven to reduce the risk and rate of exacerbations3*

In a 24- to 76-week study of patients with a history of asthma exacerbations



*An asthma exacerbation is defined as a deterioration of asthma that required the use of systemic corticosteroids for at least 3 days or an inpatient hospitalization or ED visit due to asthma that required systemic corticosteroids.

ED=emergency department; FF=fluticasone furoate.


  1. Bernstein DI, Bateman ED, Woodcock A, et al. Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100 mcg) in persistent asthma. J Asthma. 2018;55(8):890-897.
  2. Bleecker ER, Lötvall J, O’Byrne PM, et al. Fluticasone furoate-vilanterol 100-25 mcg compared with fluticasone furoate 100 mcg in asthma: a randomized trial. J Allergy Clin Immunol Pract. 2014;2(5):553-561.
  3. Bateman ED, O’Byrne PM, Busse WW, et al. Once-daily fluticasone furoate (FF)/vilanterol reduces risk of severe exacerbations in asthma versus FF alone. Thorax. 2014;69(4):312-319.
  4. Data on file, GSK.
  5. O’Byrne PM, Bleecker ER, Bateman ED, et al. Once-daily fluticasone furoate alone or combined with vilanterol in persistent asthma. Eur Respir J. 2014;43:773-782.
  6. Kerwin E, Barnes N, Gibbs M, et al. Fluticasone furoate/vilanterol once daily improves night-time awakenings in asthma patients with night symptoms; post-hoc analyses of three randomized controlled trials. J Asthma. 2018;55(8):890-897.
  7. Data on file, GSK. Study 201594.