Table 2.

Key inclusion criteria of TRILOGY²⁴ and TRINITY²⁵ studies

• Age ≥40 years

• Diagnosis of COPD at least 12 months before screening

• Current smokers or ex-smokers with a smoking history of at least 10 pack-years

• A post-bronchodilator FEV1 <50% of the predicted normal value and a post-bronchodilator FEV1/FVC <0.7, within 30 min after four puffs (4×100 µg) of salbutamol pMDI

• A documented history of at least one exacerbation in the 12 months preceding screening

• Patients under double therapy for at least 2 months prior to screening with either

ICS + LABA

ICS + LAMA

LABA + LAMA

LAMA

• CAT score ≥10

• BDI focal score ≤10a

Note:

^aIn TRILOGY only.

Abbreviations: BDI, baseline dyspnea index; CAT, COPD assessment test; FEV₁, forced expiratory volume in the first second; FVC, forced vital capacity; ICS, inhaled corticosteroid; LABA, long-acting beta₂ agonist; LAMA, long-acting muscarinic antagonist; pMDI, pressurized metered dose inhaler.