Efficacy vs SYMBICORT TURBUHALER 400/12* (an ICS/LABA)
†Based on IQVIA Patient Level Data as of November 2020.
Lung Function: FULFIL
Health-Related Quality-of-life: FULFIL
Exacerbation Rate: FULFIL
Adverse Events: FULFIL
TRELEGY significantly improved lung function


*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


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 is the percentage of patients with a response, defined as a decrease from baseline of 4 or more in SGRQ total score.1
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
The most commonly reported adverse events with ≥2% incidence from the 24‑week FULFIL trial, a non-US study1,4
TRELEGY (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 |
Review a head-to-head trial of TRELEGY in adult patients with ASTHMA.