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ETHOS Trial2

Double blind; ≥1 moderate or severe COPD exacerbation(s) in year prior to screening

The ETHOS trial (N=8588): All patients had ≥1 moderate or severe COPD exacerbation(s) in year prior to screening

  • Length: 52 weeks
  • Population: Aged 40–80 years

TRIXEO
ICS/LAMA/LABA pMDI

320/18/9.6 μg BID
(n=2157)

ICS/LAMA/LABA pMDI

160/18/9.6 μg BID (n=2137)

Primary endpoint:
  •  Annual rate of moderate or severe COPD exacerbations (as estimated over 52 weeks)*

LAMA/LABA pMDI

18/9.6 μg BID
(n=2143)

ICS/LABA pMDI

320/9.6 μg BID
(n=2151)

Key secondary endpoints:

  • Annual rate of severe COPD exacerbations
  • Change from baseline in SGRQ total score over 24 weeks
  • Time to death from any cause
TRIXEO - PROTECTION AGAINST MODERATE OR SEVERE EXACERBATIONS
TRIXEO - PROTECTION AGAINST COPD HOSPITALISATIONS
TRIXEO - REDUCES SYMPTOMS OF COPD AND IMPROVES QUALITY OF LIFE
Adverse events that occurred in ≥3% of patients in any group (safety population) in the ETHOS study

TRIXEO: PROTECTION AGAINST
MODERATE OR SEVERE EXACERBATIONS2

Significant reductions in the rate of moderate or severe exacerbations
vs LAMA/LABA and ICS/LABA2

The NNT* for 1 year with TRIXEO to prevent 1 moderate or severe COPD exacerbation was 3 (95% CI 3–5) and 7 (95% CI 4–18) vs LAMA/LABA or ICS/LABA, respectively10

DEFINITION OF EXACERBATIONS

Moderate exacerbations were defined as events requiring the use of OCS/systemic corticosteroids and/or antibiotics for at least 3 days. Severe exacerbations were defined as events resulting in inpatient COPD-related hospitalisation or COPD-related death.2,3

*NNT is the number needed to treat for 1 year to prevent 1 moderate/severe COPD exacerbation. NNH calculated using 1/(rateBGF pMDI – ratecomparator)10

TRIXEO: PROTECTION AGAINST
COPD HOSPITALISATIONS2*

The ONLY triple therapy to significantly reduce hospitalisations vs ICS/LABA in ETHOS2

ETHOS was a 52-week trial that compared TRIXEO with GFF pMDI (LAMA/LABA) and BFF pMDI (ICS/LABA).1

*Hospitalisations defined as exacerbation events resulting in inpatient COPD-related hospitalisation or COPD-related death2

TRIXEO: REDUCES SYMPTOMS
OF COPD AND IMPROVES QUALITY OF LIFE4,5

Changes in SGRQ score over 24 weeks4,5

Adapted from Rabe KF et al. N Engl J Med. 2020

Improvement in SGRQ
over 24 weeks

–1.62 difference
vs LAMA/LABA

95% CI -2.27–-0.97; p<0.00014,5

–1.38 difference
vs ICS/LABA

95% CI -2.02–-0.73; p<0.00014,5

ETHOS was a 52-week trial that compared TRIXEO with GFF pMDI (LAMA/LABA) and BFF pMDI (ICS/LABA).1 Total scores on the SGRQ range from 0 to 100, with lower scores indicating better health-related quality of life; the minimum clinically important difference is 4 units.5

Adverse events that occurred in ≥3% of patients in any group (safety population) in the ETHOS study5

The safety profile of BUD/GLY/FORM was comparable to the profiles of GLY/FORM and BUD/FORM

In the clinical trial programme for TRIXEO, LAMA/LABA refers to glycopyrronium/ formoterol fumarate and ICS/LABA refers to budesonide/formoterol fumarate.

BFF, budesonide/formoterol fumarate dihydrate; COPD, chronic obstructive pulmonary disease; GFF, glycopyrronium/formoterol fumarate dihydrate; ICS, inhaled corticosteroids; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist; OCS, oral corticosteroids; pMDI, pressurised metered-dose inhaler