Abstract
Introduction: Decline in health status, lung function, and exacerbations are important determinants of disease progression of COPD patients (pts). CID has been proposed as a composite endpoint to evaluate COPD treatment effects. We report effect of IND/GLY on CID in pts with moderate COPD, after direct switch from LABA+ICS, or a LABA or a LAMA monotherapy. Methods: CRYSTAL, a 12-week, prospective, multicentre, randomised, open-label, pragmatic trial, evaluated the effect of IND/GLY or GLY after a direct switch from previous treatments in moderate COPD pts. CID was defined as a ≥100 mL decrease in trough FEV 1 or a ≥1 point decrease in transition dyspnoea index (TDI) or a ≥0.4 point increase in clinical COPD questionnaire (CCQ) score or a moderate/severe exacerbation. Results: Of 2,159 pts analysed in the IND/GLY treatment arms, 1,622 switched to IND/GLY and 537 continued their baseline treatment. The percentage of pts experiencing a CID was significantly lower in pts who switched to IND/GLY vs pts who continued on LABA+ICS, or on a LABA or a LAMA, using different CID definitions (Table) . Subgroup analyses according to different baseline characteristics were consistent with the overall results. Conclusion: Indacaterol/glycopyrronium significantly reduced the risk of CID in moderate COPD patients, after direct switch from LABA/ICS, or a LABA or a LAMA.
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