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There is now UK head-to-head real-world data for Trelegy Ellipta (FF/UMEC/VI) versus Trimbow (BEGF) pMDI1
Looking for real-world evidence vs Trixeo (BUD/GLY/FOR)?
Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long‑acting beta‑2 agonist (LABA), or combination of a long‑acting muscarinic antagonist (LAMA) and a LABA2
Real-world retrospective analysis of UK Clinical Practice Research Datalink (CPRD), comparing the effectiveness and safety of two licensed SITTs in COPD. Mean follow-up: 6.7 months. Study cohort included patients prescribed a SITT between September 2014 to March 2021. The efficacy and safety of Trelegy has been evaluated in two RCTs, IMPACT & FULFIL. For further information please refer to the SmPC. Interpretation of RWE is subject to limitations and may not be generalisable
In over 74,000 UK patients (age ≥40) with COPD requiring step-up to triple therapy, an independent real-world observational study showed:
Adjusted HR: 0.91 (95% CI: 0.89, 0.93). One-year cumulative incidence of first moderate–severe exacerbation: Trelegy Ellipta: 60.54% (n=34,825); Trimbow pMDI: 64.12% (n=39,288)
Adjusted by fine stratification weights from the probability of treatment propensity scores
Adjusted HR: 1.06 (95% CI 0.99, 1.13). Rate per 100 patient-years: Trelegy Ellipta: 9.9 (n=34,825); Trimbow pMDI: 9.3 (n=39,288)
Adjusted by fine stratification weights from the probability of treatment propensity scores
Adjusted Hazard Ratios of Severe Pneumonia1
| No. of patients | Number with events | Person-years | Rate* per 100 per year | Adjusted* Hazard Ratio (95% CI) | |
|---|---|---|---|---|---|
| Overall Trelegy Ellipta Trimbow pMDI |
34,825 39,288 |
1730 2212 |
19,529 21,873 |
9.9 9.3 |
1.06 (0.99-1.13) 1.00 (Reference) |
| Group E (≥2 moderate or 1 severe exacerbation) Trelegy Ellipta Trimbow pMDI |
15,753 20,314 |
1108 1490 |
8779 11,443 |
13.9 12.2 |
1.14 (1.06-1.24) 1.00 (Reference) |
| Not Group E (≤1 moderate exacerbation) Trelegy Ellipta Trimbow pMDI |
19,072 18,974 |
622 722 |
10,750 10,430 |
6.1 6.5 |
0.93 (0.84-104) 1.00 (Reference) |
| Prior asthma diagnosis Trelegy Ellipta Trimbow pMDI |
8447 10,333 |
365 524 |
4724 5679 |
8.8 8.5 |
1.05 (0.91-120) 1.00 (Reference) |
| No prior asthma diagnosis Trelegy Ellipta Trimbow pMDI |
26,378 28,955 |
1365 1688 |
14,805 16,194 |
10.2 9.6 |
1.06 (0.99-1.14) 1.00 (Reference) |
| Baseline FEV1 (<50% predicted)** Trelegy Ellipta Trimbow pMDI |
12,176 15,051 |
709 1015 |
6945 8891 |
11.2 10.7 |
1.04 (0.94-1.15) 1.00 (Reference) |
| Baseline FEV1 (≥50% predicted)** Trelegy Ellipta Trimbow pMDI |
19,254 19,195 |
758 776 |
10,981 10,663 |
7.4 6.8 |
1.09 (0.99-1.21) 1.00 (Reference) |
| Baseline blood eosinophils (≤300 cells/µL) † Trelegy Ellipta Trimbow pMDI |
23,580 27,174 |
1253 1560 |
13,127 15,113 |
10.6 9.6 |
1.10 (1.02-1.19) 1.00 (Reference) |
| Baseline blood eosinophils (>300 cells/µL) † Trelegy Ellipta Trimbow pMDI |
6996 7709 |
339 459 |
3974 4285 |
9.6 9.7 |
0.99 (0.86-1.14) 1.00 (Reference) |
in Patients with COPD in the First Year After Treatment Initiation, from the as-Treated Analyses, Stratified by GOLD Group E Classification of Prior Exacerbations, FEV1, Peripheral Blood Eosinophil Count and Cardiovascular Disease, Estimated from the Cox Proportional Hazards Model. *Adjusted by fine stratification weights from the probability of treatment propensity scores. **Based on available data from 89% of subjects. †Based on available data from 88% of subjects. Adapted from Cherian M et al, 2026.
Trelegy Ellipta also has head-to-head real-world data versus another triple therapy – Trixeo (BUD/GLY/FOR)3
Study design1
Independent real-world retrospective analysis of UK Clinical Practice Research Datalink (CPRD), a primary care database and linked hospital databases
Comparing effectiveness and safety of Trelegy Ellipta and Trimbow pMDI in over 74,000 patients with COPD (≥40 years) deemed to require a step-up to single inhaler triple therapy:
Study conducted between September 2014 to 31st March 2021. Mean follow-up: 6.7 months. New-user cohort design with propensity matching* used to balance treatment arms.
*Adjusted by fine stratification weights from the probability of treatment propensity scores.
| Key patient characteristics | Trimbow pMDI (n=39,288) | Trelegy Ellipta (n=34,825) |
|---|---|---|
Age at cohort entry, mean (sd) |
71.1 (10.2) |
71.0 (10.2) |
Female sex, n (%) |
19,422 (49.4%) |
17,238 (49.5%) |
FEV1 (% predicted)*, mean (sd) |
55.8 (19.6) |
56.0 (19.6) |
Blood eosinophils cells/µL**, mean (sd) |
247.8 (217.6) | 248.4 (216.3) |
Respiratory events in year prior to cohort entry |
||
Hospitalisation for COPD, n (%) |
4777 (12.2%) |
4247 (12.2%) |
Moderate or severe COPD exacerbation |
||
None, n (%) |
13,108 (33.4%) |
11,579 (33.3%) |
One, n (%) |
8132 (20.7%) |
7192 (20.7%) |
Two or more, n (%) |
18,048 (45.9%) |
16,053 (46.1%) |
This is not a fully comprehensive list. *Based on available data from 89% of subjects. **Based on available data from 88% of subjects. Adapted from Cherian M et al, 2026.
In a randomised, open-label cross over study in 567 patients with COPD
Side effects
Common (≥1/100 to <1/10): pneumonia, upper respiratory tract infection, bronchitis, pharyngitis, rhinitis, sinusitis, influenza, nasopharyngitis, candidiasis of mouth and throat, urinary tract infection, headache, cough, oropharyngeal pain, constipation, arthralgia, back pain.
Other important side effects include
Uncommon (≥1/1,000 to <1/100): viral respiratory tract infection, dysgeusia, dysphonia, dry mouth, fractures, supraventricular tachyarrhythmia, tachycardia, atrial fibrillation, vision blurred, glaucoma, eye pain.
Rare (≥1/10,000 to <1/1,000): anxiety, tremor, intraocular pressure increased, muscle spasms, dysuria, hypersensitivity reactions, including anaphylaxis, angioedema, urticaria and rash; hyperglycaemia; palpitations and urinary retention.
Systemic effects: Systemic effects of ICS may occur, particularly at high doses for long periods, but much less likely than with oral corticosteroids.
Not for acute use - there are no clinical data to support the use of Trelegy Ellipta for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Deterioration of disease - increasing use of short-acting bronchodilators to relieve symptoms may indicate deterioration of disease control. In the event of deterioration of COPD during treatment with Trelegy Ellipta, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken. Patients should not stop therapy with Trelegy Ellipta without physician supervision since symptoms may recur after discontinuation.
This is not an exhaustive list. Please consult the Summary of Product Characteristics for a full list of adverse reactions, special warnings and precautions.
Abbreviations: BEGF, beclometasone/glycopyrronium/formoterol; BUD/GLY/FOR, budesonide/glycopyrronium/formoterol; CES, comparative effectiveness study; CI, confidence interval; FF/UMEC/VI, fluticasone furoate/umeclidinium/vilanterol; HR, hazard ratio; ICS: inhaled corticosteroid; KM, Kaplan-meier; LABA: long-acting beta agonist; LAMA: long-acting muscarinic antagonist; pMDI, pressurised meter dose inhaler; RCTs, randomised controlled trials
References:
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to GSK on 0800 221 441 or UKSafety@gsk.com.
September 2026 | PM-GB-FVU-WCNT-260006 (V1.0)