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KRONOS trial6

Double blind; No requirement for a 1-year exacerbation history

74% of patients in this trial did not have any history of moderate or severe exacerbation in the year prior to screening

  • Length: 24 weeks
  • Population: Aged 40–80 years

TRIXEO
ICS/LAMA/LABA pMDI

320/18/9.6 μg BID
(n=640)

LAMA/LABA pMDI

18/9.6 μg BID
(n=627)

Primary endpoint:
  • Change from baseline in morning predose trough FEV1 over 24 weeks
  • FEV1 AUC0-4 over 24 weeks

ICS/LABA pMDI

320/9.6 μg BID
(n=316)

Open-Label ICS/LABA DPI

400/12 μg BID
(n=319)

Key secondary endpoints:

  • Rate of moderate or severe COPD exacerbations
  • Change from baseline in morning predose trough FEV1
TRIXEO - SUSTAINED IMPROVEMENTS IN LUNG FUNCTION
TRIXEO - SUSTAINED IMPROVEMENTS in FEV AUC
TRIXEO - PROTECTION AGAINST EXACERBATIONS
TRIXEO - PROTECTION AGAINST COPD HOSPITALISATIONS
ADVERSE EVENTS IN KRONOS STUDY

TRIXEO: SUSTAINED IMPROVEMENTS
IN LUNG FUNCTION1,6

TRIXEO significantly improved morning predose trough FEV1 over 24 weeks vs dual therapies1,6

KRONOS was a 24-week trial that compared TRIXEO with GFF pMDI (LAMA/LABA) and BFF pMDI or DPI (ICS/LABA).6

AUC0–4, area under the curve 0–4; BFF, budesonide/formoterol fumarate dihydrate; DPI, dry powder inhaler; FEV1, volume that has been exhaled at the end of the first second of forced expiration; GFF, glycopyrronium/formoterol fumarate dihydrate; ICS, inhaled corticosteroids; ITT, intention-to-treat; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist; pMDI, pressurised metered-dose inhaler; SE, standard error.

TRIXEO: SUSTAINED IMPROVEMENTS in FEV1 AUC0–4

TRIXEO significantly improved FEV1 AUC0–4 over 24 weeks vs ICS/LABA6

KRONOS was a 24-week trial that compared TRIXEO with GFF pMDI (LAMA/LABA) and BFF pMDI or DPI (ICS/LABA).6

TRIXEO: PROTECTION AGAINST EXACERBATIONS1,6

TRIXEO reduced the rate of moderate or severe exacerbations by 52% vs LAMA/LABA1,6
(secondary endpoint)

KRONOS was a 24-week trial that compared TRIXEO with GFF pMDI (LAMA/LABA) and BFF pMDI or DPI (ICS/LABA).1

TRIXEO: PROTECTION AGAINST
COPD Hospitalisations3

TRIXEO reduced the rate of COPD hospitalisations by 64% vs LAMA/LABA3 The rate of severe exacerbation reduction was nominally significant3

KRONOS was a 24-week trial that compared TRIXEO with GFF pMDI (LAMA/LABA) and BFF pMDI or DPI (ICS/LABA).1

†The p-value is unadjusted because it was not included in the Type 1 error control plan.12

Adverse events that occurred in ≥2% of patients in any group (safety population) in the KRONOS study6

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 DPI, dry powder inhaler; FEV1, volume that has been exhaled at the end of the first second of forced expiration;