TRELEGY demonstrated improvements across multiple endpoints vs SYMBICORT TURBUHALER 400/12^1*

Help patients breathe better with TRELEGY

FULFIL, a non-US study, compared 24 weeks of once-daily TRELEGY with twice-daily ICS/LABA therapy. ¹

^* SYMBICORT TURBUHALER 400/12 is a non-US formulation that delivers budesonide/formoterol 320/9 and is administered via 1 inhalation taken twice daily.^2,3

See results from IMPACT, a landmark trial of 10,000+ patients with a history of COPD exacerbations.

Lung Function Improvement Quality-of-life Improvement Exacerbation Reduction Adverse Events

Lung Function Improvement
Quality-of-life Improvement
Exacerbation Reduction
Adverse Events

In a 24-week, non-US study vs a twice-daily ICS/LABA

TRELEGY demonstrated significant 171 mL lung function improvement vs SYMBICORT TURBUHALER 400/12^1*

Co-primary endpoint: change from baseline in trough FEV₁ at Week 24^1,4

^*SYMBICORT TURBUHALER 400/12 is a non-US formulation that delivers budesonide/formoterol 320/9 and is administered via 1 inhalation taken twice daily.^2,3

See lung function improvement at 52 weeks (extension data)1,4

In an additional analysis (not adjusted for multiplicity): TRELEGY demonstrated a 179-mL improvement in lung function vs SYMBICORT TURBUHALER 400/12.^1,4*

LS mean change from baseline in trough FEV₁ at Week 52 was 126 mL for TRELEGY (n=183) and –53 mL for SYMBICORT TURBUHALER 400/12^* (n=171).^1,4

^*SYMBICORT TURBUHALER 400/12 is a non-US formulation that delivers budesonide/formoterol 320/9 and is administered via 1 inhalation taken twice daily.^2,3
FULFIL study description1,4

The FULFIL trial was a 24-week, randomized, double-blind, double-dummy, parallel-group, multicenter, non-US study that evaluated the efficacy and safety of once-daily TRELEGY 100 vs twice-daily SYMBICORT TURBUHALER 400/12^* in patients with COPD. A subset of 430 patients continued on blinded treatment through an extension phase for up to 52 weeks. At screening, patients (N=1810, mean age: 64 years) with COPD had a mean postbronchodilator percent predicted FEV₁ of 45.3% and a mean postbronchodilator FEV₁/FVC ratio of 0.45. In the 12 months prior to screening, 35% of patients had no moderate to severe exacerbations. Exacerbations were moderate if treatment with systemic corticosteroids and/or antibiotics was required and severe if hospitalization was required.

^*SYMBICORT TURBUHALER 400/12 is a non-US formulation that delivers budesonide/formoterol 320/9 and is administered via 1 inhalation taken twice daily.^2,3

In a 24-week, non-US study vs a twice-daily ICS/LABA

TRELEGY significantly improved quality of life vs SYMBICORT TURBUHALER 400/12^1*

Patients taking TRELEGY were more likely to show an improvement in quality of life at Week 24 vs SYMBICORT TURBUHALER 400/12,^* as measured by SGRQ.¹

SGRQ is a validated, respiratory disease-specific, patient-reported instrument that assesses symptoms, activities, and impact on daily life domains⁵

^*SYMBICORT TURBUHALER 400/12 is a non-US formulation that delivers budesonide/formoterol 320/9 and is administered via 1 inhalation taken twice daily.^2,3

Co-primary endpoint: change from baseline in SGRQ total score at Week 24¹

TRELEGY demonstrated a 2.2^† greater reduction from baseline in SGRQ total score vs SYMBICORT TURBUHALER 400/12^1* (P<0.001).

^† Reflects rounding.

Supporting analysis: SGRQ responder rate^‡ at Week 24.¹

Analysis was not controlled for multiplicity.

TRELEGY 100

50^%

(448/904)

SYMBICORT TURBUHALER 400/12^*

41^%

(368/893)

(OR: 1.41; 95% CI: 1.16, 1.70)

50% of patients taking TRELEGY responded to the SGRQ vs 41% for SYMBICORT TURBUHALER 400/12.^1*

^*SYMBICORT TURBUHALER 400/12 is a non-US formulation that delivers budesonide/formoterol 320/9 and is administered via 1 inhalation taken twice daily.^2,3

^‡Responder rate is the percentage of patients with a response, defined as a decrease from baseline of 4 or more in SGRQ total score.¹

See quality-of-life improvements at 52 weeks (extension data)1

In an additional analysis (not adjusted for multiplicity): TRELEGY (n=182) demonstrated an improvement from baseline in SGRQ total score of –4.6 units compared with –1.9 units for SYMBICORT TURBUHALER 400/12^*(n=174) at Week 52; difference –2.7 (95% CI: –5.5, 0.2).¹

The SGRQ responder rate at Week 52 was greater for TRELEGY (44%, 91/209) compared with SYMBICORT TURBUHALER 400/12^* (33%, 73/219) with an OR of 1.5 (95% CI: 1.01, 2.24).¹

^*SYMBICORT TURBUHALER 400/12 is a non-US formulation that delivers budesonide/formoterol 320/9 and is administered via 1 inhalation taken twice daily.^2,3
FULFIL study description1,4

The FULFIL trial was a 24-week, randomized, double-blind, double-dummy, parallel-group, multicenter, non-US study that evaluated the efficacy and safety of once-daily TRELEGY 100 vs twice-daily SYMBICORT TURBUHALER 400/12^* in patients with COPD. A subset of 430 patients continued on blinded treatment through an extension phase for up to 52 weeks. At screening, patients (N=1810, mean age: 64 years) with COPD had a mean postbronchodilator percent predicted FEV₁ of 45.3% and a mean postbronchodilator FEV1/FVC ratio of 0.45. In the 12 months prior to screening, 35% of patients had no moderate to severe exacerbations. Exacerbations were moderate if treatment with systemic corticosteroids and/or antibiotics was required and severe if hospitalization was required.

*SYMBICORT TURBUHALER 400/12 is a non-US formulation that delivers budesonide/formoterol 320/9 and is administered via 1 inhalation taken twice daily.^2,3

In a 24-week, non-US study vs a twice-daily ICS/LABA

TRELEGY demonstrated a 35% reduction in exacerbation rate reduction vs SYMBICORT TURBUHALER 400/12^1*

Secondary endpoint: annual rate of moderate to severe exacerbations¹

Endpoint was not adjusted for multiplicity

See the reduction of severe (hospitalized) exacerbations with TRELEGY vs ANORO and vs BREO

TRELEGY demonstrated a 35% reduction in the annual rate of moderate to severe exacerbations vs SYMBICORT TURBUHALER 400/12.^1*

This study included patients who had received triple therapy (ICS + LABA + LAMA) before entering and were stepped down to the comparator arm (ICS/LABA).¹

Exacerbation severity criteria: Moderate if treatment with systemic corticosteroids and/or antibiotics was required and severe if hospitalization was required.¹

^*SYMBICORT TURBUHALER 400/12 is a non-US formulation that delivers budesonide/formoterol 320/9 and is administered via 1 inhalation taken twice daily.^2,3

See the reduction of severe (hospitalized) exacerbations with TRELEGY vs ANORO and vs BREO

FULFIL study description1,4

The FULFIL trial was a 24-week, randomized, double-blind, double-dummy, parallel-group, multicenter, non-US study that evaluated the efficacy and safety of once-daily TRELEGY 100 vs twice-daily SYMBICORT TURBUHALER 400/12^* in patients with COPD. A subset of 430 patients continued on blinded treatment through an extension phase for up to 52 weeks. At screening, patients (N=1810, mean age: 64 years) with COPD had a mean postbronchodilator percent predicted FEV₁ of 45.3% and a mean postbronchodilator FEV₁/FVC ratio of 0.45. In the 12 months prior to screening, 35% of patients had no moderate to severe exacerbations. Exacerbations were moderate if treatment with systemic corticosteroids and/or antibiotics was required and severe if hospitalization was required.

^*SYMBICORT TURBUHALER 400/12 is a non-US formulation that delivers budesonide/formoterol 320/9 and is administered via 1 inhalation taken twice daily.^2,3

Adverse Events reported in the FULFIL trial

From the 24-week, non-US FULFIL trial, the most commonly reported adverse events with ≥2% incidence were¹:

Adverse Events	TRELEGY 100 (n=911) %	*SYMBICORT TURBUHALER 400/12 (n=899)** %
Nasopharyngitis	7	5
Headache	5	6
URTI	2	2
COPD^§	2	3
Back pain	2	2
Arthralgia	2	1
Pneumonia	2	<1
Pharyngitis	2	1

^§Signs, symptoms, or progression of COPD is more severe than expected for the patient’s condition.

In the non-US FULFIL trial: Incidence of Pneumonia (Adverse Events of Special Interest)¹

TRELEGY 100

SYMBICORT

TURBUHALER

400/12*

24 Weeks

(n=911)

2.2

(n=899)

0.8

52 Weeks

(extension population)

(extension

population)

(n=210)

1.9

(n=220)

1.8

^*SYMBICORT TURBUHALER 400/12 is a non-US formulation that delivers budesonide/formoterol 320/9 and is administered via 1 inhalation taken twice daily.^2,3

^¶Signs, symptoms, or progression of COPD is more severe than expected for the patient's condition.

See helpful resources for your practice.

Explore resources

Help your patients try
TRELEGY.

Request samples now

What is the starting dose of TRELEGY for adult patients with ASTHMA?

See dosing considerations

Review a head-to-head trial of TRELEGY in adult patients with ASTHMA.

Learn more

INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS & IMPORTANT SAFETY INFORMATION

INDICATIONS

COPD: TRELEGY 100/62.5/25 is for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Asthma: TRELEGY is for maintenance treatment of adults with asthma.

Limitations of Use: TRELEGY is NOT for the relief of acute bronchospasm.

COPD: TRELEGY 100/62.5/25 is for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Asthma: TRELEGY is for maintenance treatment of adults with asthma.

Limitations of Use: TRELEGY is NOT for the relief of acute bronchospasm.

INDICATIONS

COPD: TRELEGY 100/62.5/25 is for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Asthma: TRELEGY is for maintenance treatment of adults with asthma.

Limitations of Use: TRELEGY is NOT for the relief of acute bronchospasm.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

TRELEGY is contraindicated in the following:

Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required.
Patients with severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate (FF), umeclidinium (UMEC), vilanterol (VI), or any of the excipients.

WARNINGS AND PRECAUTIONS

Long-acting beta₂-adrenergic agonist (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 inhaled corticosteroids (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. TRELEGY is not indicated for use in pediatric patients aged 17 years and younger.
TRELEGY should NOT be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD or asthma.
TRELEGY 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.
TRELEGY should not be used more often or at higher doses than recommended or with another LABA 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 orally inhaled drug products containing fluticasone furoate. Advise patients to rinse their mouths with water without swallowing after inhalation.
Lower respiratory tract infections, including pneumonia, have been reported following use of ICS, like fluticasone furoate. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD, as clinical features of pneumonia and exacerbations frequently overlap.
A more serious or even fatal course of chickenpox or measles may occur in susceptible patients using corticosteroids. ICS should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
Particular care is needed for patients transferred from systemic corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients during and after transfer. Taper patients slowly from systemic corticosteroids if transferring to TRELEGY.
Hypercorticism and adrenal suppression may occur with higher than the recommended dosage or at the regular dosage of ICS in susceptible individuals. If such changes occur, reduce the dose of TRELEGY slowly and consider other treatments for management of COPD or asthma symptoms.
Caution should be exercised when considering the coadministration of TRELEGY with ketoconazole and other known strong CYP3A4 inhibitors (including, but not limited to, 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 TRELEGY and institute alternative therapy.
Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of TRELEGY. Discontinue TRELEGY 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, TRELEGY may need to be discontinued. TRELEGY 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 ICS. 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 prior to initiating TRELEGY and periodically thereafter.
Glaucoma, increased intraocular pressure, and cataracts have been reported following the long‐term administration of ICS or inhaled anticholinergics. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use TRELEGY long term.
Use with caution in patients with narrow-angle glaucoma. Instruct patients to contact a healthcare provider immediately if signs or symptoms of acute narrow-angle glaucoma develop.
Use with caution in patients with urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to contact a healthcare provider immediately if signs or symptoms of urinary retention develop.
Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
Be alert to hypokalemia and hyperglycemia.
Orally inhaled corticosteroids may reduce growth velocity in children and adolescents.

ADVERSE REACTIONS: TRELEGY 100/62.5/25 MCG FOR COPD

In subjects with COPD, the most common adverse reactions (≥1% and more common than placebo + FF/VI) reported in two 12-week clinical trials with UMEC + FF/VI, the components of TRELEGY, (and placebo + FF/VI) were: headache, 4% (3%); back pain, 4% (2%); dysgeusia, 2% (<1%); diarrhea, 2% (<1%); cough, 1% (<1%); oropharyngeal pain, 1% (0%); and gastroenteritis, 1% (0%).
Additional adverse reactions (≥1% incidence) reported in subjects with COPD taking TRELEGY in a 52-week trial included upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, constipation, urinary tract infection, and dysphonia.

ADVERSE REACTIONS: TRELEGY FOR ASTHMA

In subjects with asthma, the most common adverse reactions (≥2% incidence with TRELEGY) reported in a 24-week to 52-week clinical trial with:
- TRELEGY 100/62.5/25 mcg (or FF/VI 100/25 mcg) were: pharyngitis/nasopharyngitis, 17% (16%); headache, 9% (7%); upper respiratory tract infection/viral upper respiratory tract infection, 5% (7%); respiratory tract infection/viral respiratory tract infection, 4% (4%); bronchitis, 4% (3%); influenza, 4% (3%); back pain, 3% (4%); sinusitis/acute sinusitis, 2% (3%); rhinitis, 2% (3%).
- TRELEGY 200/62.5/25 mcg (or FF/VI 200/25 mcg) were: pharyngitis/nasopharyngitis, 15% (16%); upper respiratory tract infection/viral upper respiratory tract infection, 7% (6%); headache, 5% (6%); bronchitis, 5% (5%); sinusitis/acute sinusitis, 3% (2%); respiratory tract infection/viral respiratory tract infection, 3% (2%); back pain, 2% (1%); urinary tract infection, 2% (<1%).

DRUG INTERACTIONS

TRELEGY 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.
Avoid coadministration of TRELEGY with other anticholinergic-containing drugs, as this may lead to an increase in anticholinergic adverse effects.

USE IN SPECIFIC POPULATIONS

TRELEGY is not indicated for use in children and adolescents. The safety and efficacy in pediatric patients (aged 17 years and younger) have not been established.
Use TRELEGY with caution in patients with moderate or severe hepatic impairment, as fluticasone furoate systemic exposure may increase by up to 3-fold. Monitor for corticosteroid-related side effects.

Please see full Prescribing Information, including Patient Information, for TRELEGY.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

TRELEGY is contraindicated in the following:

Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required.

CONTRAINDICATIONS

TRELEGY is contraindicated in the following:

Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required.

IMPORTANT SAFETY INFORMATION

${body_static_right}

Definitions

CI=confidence interval; COPD=chronic obstructive pulmonary disease; FEV₁=forced expiratory volume in 1 second; FULFIL=lung FUnction and quality of LiFe assessment in COPD with closed trIpLe therapy; FVC=forced vital capacity; ICS=inhaled corticosteroid; IMPACT=InforMing the PAthway of COPD Treatment; LABA=long-acting beta₂-adrenergic agonist; LAMA=long-acting muscarinic antagonist; LS=least squares; OR=odds ratio; SGRQ=St. George's Respiratory Questionnaire; UMEC=umeclidinium; URTI=upper respiratory tract infection.

References

Lipson DA, Barnacle H, Birk R, et al. FULFIL trial: once-daily triple therapy for patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2017;196(4):438-446, Online Data Supplement.
SYMBICORT [US package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals, LP; July 2019.
SYMBICORT [UK package insert]. Luton, LU1, 3LU, UK; AstraZeneca UK Ltd; February 2021.
Data on file, GSK.
Jones PW, Quirk FW, Baveystock CM. The St. George’s Respiratory Questionnaire. Respir Med. 1991;85(suppl B):25-31.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

TRELEGY ELLIPTA was developed in collaboration with

The shape of the ELLIPTA inhaler is a trademark of the GSK group of companies.

Trademarks are property of their respective owners.

modal Window

This website is funded and developed by GSK.
This site is intended for US healthcare professionals only.
©2022 GSK or licensor.
FVUWCNT210053 January 2022
Produced in USA.

TRELEGY demonstrated improvements across multiple endpoints vs SYMBICORT TURBUHALER 400/121*

Help patients breathe better with TRELEGY

Lung Function Improvement Quality-of-life Improvement Exacerbation Reduction Adverse Events

TRELEGY demonstrated significant 171 mL lung function improvement vs SYMBICORT TURBUHALER 400/121*

Co-primary endpoint: change from baseline in trough FEV1 at Week 241,4

TRELEGY significantly improved quality of life vs SYMBICORT TURBUHALER 400/121*

TRELEGY demonstrated a 35% reduction in exacerbation rate reduction vs SYMBICORT TURBUHALER 400/121*

Secondary endpoint: annual rate of moderate to severe exacerbations1

Adverse Events reported in the FULFIL trial

TRELEGY demonstrated improvements across multiple endpoints vs SYMBICORT TURBUHALER 400/12^1*

Lung Function Improvement
Quality-of-life Improvement
Exacerbation Reduction
Adverse Events

TRELEGY demonstrated significant 171 mL lung function improvement vs SYMBICORT TURBUHALER 400/12^1*

Co-primary endpoint: change from baseline in trough FEV₁ at Week 24^1,4

TRELEGY significantly improved quality of life vs SYMBICORT TURBUHALER 400/12^1*

TRELEGY demonstrated a 35% reduction in exacerbation rate reduction vs SYMBICORT TURBUHALER 400/12^1*

Secondary endpoint: annual rate of moderate to severe exacerbations¹