Main characteristics of the IMPACT and ETHOS trials
| Study (study period) | Inclusion/exclusion criteria | Treatment | Included patients | Characteristics of patients at inclusion | ||||||
| Age and symptoms | FEV1 and exacerbation history# | History of asthma/ eosinophils | ICS use before inclusion | Treatment arms | Mean age, years | Men (%) | Mean blood Eosinophils | Bronchodilator reversibility | ||
| IMPACT (2014–2017) | Age ≥40 years CAT ≥10 | FEV1 <50% and ≥1 moderate-to-severe exacerbation OR 50%<FEV1<80% and ≥1 severe exacerbation or ≥2 moderate exacerbations | Prior (but not current) history of asthma allowed No restriction regarding blood eosinophils | 70% | Randomisation 2:2:1 ratio: 1) ICS (FF)+LAMA (UMEC)+LABA (VI) (triple therapy); 2) ICS (FF)+LABA (VI); 3) LAMA (UMEC)+LABA (VI) | 10 355 | 65 | 66% | 170 cells per mm3 | 18% |
| ETHOS (2015–2019) | Age 40–80 years CAT ≥10 | FEV1 <50% and ≥1 moderate-to-severe exacerbation OR 50%<FEV1<65% and ≥1 severe exacerbation or ≥2 moderate exacerbation | Prior (but not current) history of asthma allowed No restriction regarding blood eosinophils | 80% | Randomisation 1:1:1:1 ratio: 1) ICS (BUD 320 µg)+LABA (FOR)+LAMA (GLY) (triple therapy, high-dose ICS) 2) ICS (BUD 160 µg)+LABA (FOR)+LAMA (GLY) (triple therapy, low-dose ICS) 3) ICS (BUD 320 µg)+LABA (FOR) 4) LAMA (GLY)+LABA (FOR) | 8588 | 65 | 60% | 167 cells per mm3 | 31% |
FEV1: forced expiratory volume in 1 s; CAT: COPD Assessment Test; ICS: inhaled corticosteroid; FF: fluticasone furoate; LAMA: long-acting muscarinic antagonist; UMEC: umeclidinium; LABA: long-acting β2-agonist; VI: vilanterol; BUD: budesonide; GLY: glycopyrrolate; FOR: formoterol. #: exacerbation history in the past 12 months.