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Table 3 Effects of a direct switch to IND/GLY from baseline treatments on CAT, CCQ and rescue medication use (ITT population)

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

 

LABA + ICS n = 269

IND/GLY n = 811

LABA or LAMAa n = 268

IND/GLYa n = 811

Total CAT score, change from baseline at Week 12

−0.4 (4.8)

−1.4 (5.4)

−0.9 (5.0)

−1.9 (5.3)

Patients who achieved MCID in total CAT score (≥2 units difference from baseline), n (%)

89 (33.1%)

311 (38.4%)

112 (41.8%)

351 (43.3%)

CAT responders (decrease ≥2 units; OR [95% CI])

1.44 (1.06 to 1.95)

1.12 (0.83 to 1.50)

Total CCQ score, change from baseline at Week 12

−0.1 (0.7)

−0.2 (0.8)*

−0.1 (0.8)

−0.3 (0.8)***

Patients who achieved MCID in the total CCQ score (≥0.4 units difference from baseline), n (%)

64 (23.8%)

243 (30.0%)

74 (27.6%)

293 (36.1%)

CCQ responders (decrease ≥0.4 units; OR [95% CI])

1.53 (1.10 to 2.12)

1.58 (1.16 to 2.17)

Number of puffs of rescue medication over 12 weeks

1.6 (1.7)

1.1 (1.4)****

1.4 (1.4)

1.1 (1.3)***

Percentage of days without rescue medication use over 12 weeks

41.7 (42.9)

49.9 (43.4)**

38.8 (42.6)

46.7 (42.6)**

  1. *P < 0.05; **P < 0.01; ***P < 0.001; ****P < 0.0001
  2. aPatients had an mMRC score ≥ 2
  3. Data are presented as mean (stadard deviation), unless otherwise stated
  4. CAT, COPD assessment test; CCQ, clinical COPD questionnaire; CI, confidence interval; COPD, chronic obstructive pulmonary disease; 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; mMRC, modified Medical Research Council; OR, odds ratio