Efficacy and safety of direct switch to indacaterol/glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial

Table 2 Effects of direct switch to IND/GLY from baseline treatments on trough FEV₁ and TDI total scores: proportion of patients achieving MCID (ITT population)

	LABA + ICS n = 269	IND/GLY n = 811	LABA OR LAMA^a n = 268	IND/GLY^a n = 811
Patients achieved MCID in trough FEV₁ (≥100 mL difference from baseline)	90 (33.4%)	379 (46.7%)	74 (27.6%)	388 (47.8%)
Trough FEV₁ responders (improvement ≥100 mL; OR [95% CI])	1.90 (1.42 to 2.55)		2.53 (1.86 to 3.42)
Patients achieved MCID in TDI total scores (≥1-unit difference from baseline)	91 (33.8%)	427 (52.7%)	95 (35.5%)	466 (57.5%)
TDI responders (improvement ≥1 unit; OR [95% CI])	2.61 (1.94 to 3.50)		2.85 (2.13 to 3.82)

^aPatients had an mMRC score ≥ 2
Data are presented as n (%), unless otherwise stated.CI, confidence interval; FEV₁, forced expiratory volume in 1 s; IND/GLY, indacaterol/glycopyrronium; ITT, intention-to-treat; LABA + ICS, long-acting β₂-agonist + inhaled corticosteroid; LAMA, long-acting muscarinic antagonist; MCID, minimal clinically important difference; OR, odds ratio; TDI, transition dyspnoea index

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