Lung Function

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.

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 VIDEO

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.

SHOW LESS

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.

SHOW LESS

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.

SHOW LESS

WATCH LUNG FUNCTION VIDEO

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.

SHOW LESS

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. 2015;52(10):1073‑1083.

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.

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.

CONTRAINDICATIONS

BREO is contraindicated for primary treatment of status asthmaticus or other acute episodes of chronic obstructive pulmonary disease (COPD) or asthma where intensive measures are required.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

BREO is contraindicated for primary treatment of status asthmaticus or other acute episodes of chronic obstructive pulmonary disease (COPD) or asthma where intensive measures are required.

BREO is contraindicated in patients with severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, vilanterol, or any of the excipients.

WARNINGS AND PRECAUTIONS

LABA monotherapy for asthma increases the risk of asthma-related death, and in pediatric and adolescent patients, available data also suggest an increased risk of asthma-related hospitalization. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone.
BREO should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD or asthma.
BREO is not a rescue medication and should not be used for the relief of acute bronchospasm or symptoms. Acute symptoms should be treated with an inhaled, short-acting beta₂-agonist.
BREO should not be used more often or at higher doses than recommended, or with another LABA (eg, salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs, like LABA.
Oropharyngeal candidiasis has occurred in patients treated with BREO. Advise patients to rinse the mouth with water without swallowing after inhalation.
Use caution in patients who use corticosteroids as they are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients.
Particular care is needed for patients transferred from systemic corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer. Taper patients slowly from systemic corticosteroids if transferring to BREO.
Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage of inhaled corticosteroids in susceptible individuals. If such changes occur, discontinue BREO slowly.
Caution should be exercised when considering the coadministration of BREO with ketoconazole and other known strong CYP3A4 inhibitors (eg, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid and cardiovascular adverse effects may occur.
If paradoxical bronchospasm occurs, discontinue BREO immediately and institute alternative therapy.
Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of BREO. Discontinue BREO if such reactions occur.
Vilanterol can produce clinically significant cardiovascular effects in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles. If such effects occur, BREO may need to be discontinued. BREO should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Decreases in bone mineral density have been observed with long‐term administration of products containing inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care.
Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with COPD or asthma following the long-term administration of inhaled corticosteroids. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use BREO long term.
Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
Increased blood glucose levels have been reported. Also, be alert to hypokalemia.
Orally inhaled corticosteroids may reduce growth velocity in children and adolescents.

ADVERSE REACTIONS

In a 12-week trial, adverse reactions (≥2% incidence and more common than placebo) reported in subjects taking BREO 100/25 (and placebo) were: nasopharyngitis, 10% (7%); headache, 5% (4%); oropharyngeal pain, 2% (1%); oral candidiasis, 2% (0%); and dysphonia, 2% (0%). In a separate 12-week trial, adverse reactions (≥2% incidence) reported in subjects taking BREO 200/25 (or BREO 100/25) were: headache, 8% (8%); nasopharyngitis, 7% (6%); influenza, 3% (3%); upper respiratory tract infection, 2% (2%); oropharyngeal pain, 2% (2%); sinusitis, 2% (1%); bronchitis, 2% (<1%); and cough, 1% (2%).
Additional adverse reactions (≥2% incidence) reported in subjects taking BREO 200/25 in a 24-week trial included viral respiratory tract infection, pharyngitis, pyrexia, and arthralgia; and with BREO 100/25 or 200/25 in a 12-month trial included pyrexia, back pain, extrasystoles, upper abdominal pain, respiratory tract infection, allergic rhinitis, pharyngitis, rhinitis, arthralgia, supraventricular extrasystoles, ventricular extrasystoles, acute sinusitis, and pneumonia.
In a 24- to 76-week trial of subjects with ≥1 asthma exacerbations in the past year, asthma-related hospitalizations occurred in 1% of subjects taking BREO 100/25. No asthma-related deaths or intubations were observed.

DRUG INTERACTIONS

Caution should be exercised when considering the coadministration of BREO with ketoconazole and other known strong CYP3A4 inhibitors. See prior Warning and Precaution regarding CYP3A4 inhibitors.
BREO should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval, or within 2 weeks of discontinuation of such agents, because they may potentiate the effect of vilanterol on the cardiovascular system.
Use beta-blockers with caution as they not only block the pulmonary effect of beta-agonists, such as vilanterol, but may produce severe bronchospasm in patients with COPD or asthma.
Use with caution in patients taking non–potassium-sparing diuretics, as ECG changes and/or hypokalemia associated with these diuretics may worsen with concomitant beta-agonists.

USE IN SPECIFIC POPULATIONS

BREO is not indicated for children and adolescents; the safety and efficacy in patients aged ≤17 years have not been established.
Use BREO with caution in patients with moderate or severe hepatic impairment. Fluticasone furoate systemic exposure increased by up to 3-fold in subjects with hepatic impairment. Monitor for corticosteroid-related side effects.

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LUNG FUNCTION

BREO 100/25

BREO 200/25

BREO 100/25

In a 12-week study in patients who were symptomatic on mid- to high-dose ICS

SERIAL FEV₁ (0-24 HOURS) AT WEEK 12

In a placebo-controlled 12-week study:

Study Design:

CHANGE FROM BASELINE IN TROUGH FEV₁ AT WEEK 12

Study Design:

BREO 200/25

In a 24-week study in patients who were symptomatic on mid- to high-dose ICS

SERIAL FEV₁ (0-24 HOURS) AT WEEK 24 IN A SUBSET OF PATIENTS

Study Design:

CHANGE FROM BASELINE IN TROUGH FEV₁ AT WEEK 24

Study Design:

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

In a 12-week study in patients who were symptomatic on mid- to high-dose ICS

SERIAL FEV1 (0-24 HOURS) AT WEEK 12[1]

In a placebo-controlled 12-week study[2]:

Study Design:

CHANGE FROM BASELINE IN TROUGH FEV1 AT WEEK 12[1]

Study Design:

In a 24-week study in patients who were symptomatic on mid- to high-dose ICS

SERIAL FEV1 (0-24 HOURS) AT WEEK 24 IN A SUBSET OF PATIENTS[3]

Study Design:

CHANGE FROM BASELINE IN TROUGH FEV1 AT WEEK 24[3]

Study Design:

CONTRAINDICATIONS

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

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SERIAL FEV₁ (0-24 HOURS) AT WEEK 12

In a placebo-controlled 12-week study:

CHANGE FROM BASELINE IN TROUGH FEV₁ AT WEEK 12

SERIAL FEV₁ (0-24 HOURS) AT WEEK 24 IN A SUBSET OF PATIENTS

CHANGE FROM BASELINE IN TROUGH FEV₁ AT WEEK 24