Efficacy vs SYMBICORT TURBUHALER 400/12* (an ICS/LABA)

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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.

Based on IQVIA Patient Level Data as of November 2020.

TRELEGY significantly improved lung function

In a 24-week, non-US study
Significant lung function improvement vs twice-daily SYMBICORT TURBUHALER 400/12* (an ICS/LABA)1
 
Co-primary endpoint: change from baseline in trough FEV1 at Week 241,4
Co-primary endpoint line graph
Co-primary endpoint line graph

*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 FULFIL lung function data 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

    Design: A 24-week, randomized, double-blind, double-dummy, parallel-group, multicenter study evaluating the effect of TRELEGY 100/62.5/25 mcg administered once daily compared with SYMBICORT TURBUHALER 400/12* mcg administered twice daily. Patients were eligible if they were symptomatic with a postbronchodilator FEV1 <50% predicted normal or an FEV1 <80% predicted normal and a documented history of ≥2 moderate exacerbations or 1 severe (hospitalized) exacerbation in the previous 12 months. A subset of 430 patients continued on blinded treatment through an extension phase for up to 52 weeks.

    Patients: At screening, patients (N=1810, mean age: 63.9 years) with COPD had a mean postbronchodilator percent predicted FEV1 of 45.3% and a mean postbronchodilator FEV1/FVC ratio: 0.45. In the 12 months prior to screening, 35% of patients had no moderate to severe exacerbations. Patients were randomized to treatment following a 2-week run-in period on their current COPD treatment. Current medications included ICS + LABA (29%), ICS + LABA + LAMA (28%), LAMA + LABA (10%), LAMA (9%), and other (24%).

    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

 
 
 

TRELEGY significantly improved quality of life

In a 24-week non-US study, 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 domains.5

*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

TRELEGY significantly improved quality of life vs twice-daily SYMBICORT TURBUHALER 400/12* (an ICS/LABA)1

 

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

Co-primary endpoint bar chart
Co-primary endpoint bar chart

Results reflect rounding.

*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

 

Supporting analysis: SGRQ responder rate ‡ at Week 241

Analysis was not adjusted for multiplicity.

Responder rate percentages, week 24
Responder rate percentages, week 24

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 FULFIL health-related quality-of-life data 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 odds ratio 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

    Design: A 24-week, randomized, double-blind, double-dummy, parallel-group, multicenter study evaluating the effect of TRELEGY 100/62.5/25 mcg administered once daily compared with SYMBICORT TURBUHALER 400/12* mcg administered twice daily. Patients were eligible if they were symptomatic with a postbronchodilator FEV1 <50% predicted normal or an FEV1 <80% predicted normal and a documented history of ≥2 moderate exacerbations or 1 severe (hospitalized) exacerbation in the previous 12 months. A subset of 430 patients continued blinded treatment through an extension phase for up to 52 weeks.  

    Patients: At screening, patients (N=1810, mean age: 63.9 years) with COPD had a mean postbronchodilator percent predicted FEV1 of 45.3% and a mean postbronchodilator FEV1/FVC ratio: 0.45. In the 12 months prior to screening, 35% of patients had no moderate to severe exacerbations. Patients were randomized to treatment following a 2-week run-in period on their current COPD treatment. Current medications included ICS + LABA (29%), ICS + LABA + LAMA (28%), LAMA + LABA (10%), LAMA (9%), and other (24%). 

    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

 
 
 

 

TRELEGY: exacerbation rate

Exacerbation rate vs twice-daily SYMBICORT TURBUHALER 400/12(an ICS/LABA)1
 
In a 24-week, non-US study

Secondary endpoint: annual rate of moderate to severe exacerbations1

Endpoint was not adjusted for multiplicity

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

  • FULFIL study description1,4

    Design: A 24-week, randomized, double-blind, double-dummy, parallel-group, multicenter study evaluating the effect of TRELEGY 100/62.5/25 mcg administered once daily compared with SYMBICORT TURBUHALER 400/12* mcg administered twice daily. Patients were eligible if they were symptomatic with a postbronchodilator FEV1 <50% predicted normal or an FEV1 <80% predicted normal and a documented history of ≥2 moderate exacerbations or 1 severe (hospitalized) exacerbation in the previous 12 months. A subset of 430 patients continued blinded treatment through an extension phase for up to 52 weeks.  

    Patients: At screening, patients (N=1810, mean age: 63.9 years) with COPD had a mean postbronchodilator percent predicted FEV1 of 45.3% and a mean postbronchodilator FEV1/FVC ratio: 0.45. In the 12 months prior to screening, 35% of patients had no moderate to severe exacerbations. Patients were randomized to treatment following a 2-week run-in period on their current COPD treatment. Current medications included ICS + LABA (29%), ICS + LABA + LAMA (28%), LAMA + LABA (10%), LAMA (9%), and other (24%). 

    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

Adverse events and additional safety information from the 24-week, non-US FULFIL trial

The most commonly reported adverse events with ≥2% incidence from the 24‑week FULFIL trial, a non-US study1,4

 

TRELEGY
100/62.5/25

(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

*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 are more severe than expected for the subject's condition.

Pneumonia incidence as reported from adverse events of special interest from the 24-week FULFIL trial, a non-US study1

 

TRELEGY

 100/62.5/25

%

SYMBICORT 

TURBUHALER 400/12*

%

24 Weeks

(n=911)

2.2

(n=899)

0.8

52 Weeks
(treatment subgroup)

(n=210)

1.9

(n=220)

1.8

 

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