Early Clinically Important Improvement (ECII) and Exacerbation Outcomes in COPD Patients.

ABSTRACT:

Background

Chronic obstructive pulmonary disease (COPD) exacerbations are difficult outcomes to measure in clinical trials. It would be valuable to be able to predict which patients are likely to benefit in terms of exacerbation prevention based on their early response in lung function and symptoms.

Methods

This was a post-hoc analysis from the 52-week, randomized, double-blind, double-dummy, non-inferiority FLAME trial. Early clinically important improvement (ECII) was defined as achievement of minimal clinically important difference in trough forced expiratory volume in 1 second (FEV₁; ≥100 mL increase) and one patient-reported outcome (PRO): either St. George's Respiratory Questionnaire for COPD (≥4-unit reduction; D1), or COPD assessment test (≥2-point reducti

SUBMITTER: Kostikas K 

PROVIDER: S-EPMC7435751 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature