Table 1.

Definitions of ECII

ECII Definition	Lung Function (Trough FEV1)	Patient Reported Outcome
1	Improvement ≥100 mL	Reduction in SGRQ-C score ≥4 points
2	Improvement ≥100 mL	Reduction in CAT score ≥2 points

Note: ECII is defined as an improvement measured by reaching the MCID in both lung function and a patient-reported outcome at Week 4 or Week 12 compared with Day 1 measures.

Abbreviations: CAT, COPD assessment test; COPD, chronic obstructive pulmonary disease; ECII, Early Clinical Important Improvement; FEV₁, forced expiratory volume in 1 second; SGRQ-C, St. George’s Respiratory Questionnaire for COPD.