CRYSTAL Study Results
| A1 (n = 122) | A2 (n = 369) | B1 (n = 420) | B2 (n = 1254) | C1 (n = 269) | C2 (n = 811) | D1 (n = 268) | D2 (n = 811) | ||
|---|---|---|---|---|---|---|---|---|---|
| Trough FEV1 (L) | 1.826 [1.780, 1.873] | 1.892 [1.865, 1.919] | 1.800 [1.777, 1.824] | 1.822 [1.808, 1.835] | 1.685 [1.654, 1.715] | 1.756 [1.738, 1.774] | 1.673 [1.646, 1.699] | 1.774 [1.759, 1.790] | |
| Differences in trough FEV1 (L) | 0.065 [0.011, 0.119]* | 0.021 [−0.006, 0.048]# | 0.071 [0.036, 0.107]** | 0.101 [0.071, 0.132]** | |||||
| Patients with MCID in trough FEV1( ≥ 100 mL)† | 1.770 (1.150, 2.724) | 1.401 (1.092, 1.798) | 1.902 (1.421, 2.546) | 2.526 (1.863, 3.424) | |||||
| TDI | 0.51 [−0.01, 1.03 ] | 2.30 [2.00, 2.60 ] | 0.70 [0.42, 0.98 ] | 1.44 [1.27, 1.60 ] | 0.90 [0.47, 1.23 ] | 1.95 [1.72, 2.18] | 0.90 [0.51, 1.22 ] | 2.12 [1.91, 2.33 ] | |
| Differences in TDI | 1.79 [1.19, 2.39]** | 0.74 [0.41, 1.06]# | 1.10 [0.652, 1.55]** | 1.26 [0.848, 1.67]** | |||||
| Patients with MCID in TDI ( ≥ 1 point)† | 4.58 [2.86, 7.34] | 2.57 [2.00, 3.29] | 2.609 [1.94, 3.50] | 2.853 [2.13, 3.82] | |||||
All data are LSM Data with [95% CI], unless otherwise stated
†Odds ratios are displayed with [95% CI]
Linear mixed model. All primary efficacy analysis are superiority analysis except B1-B2 which are non-inferiority analysis.
Group B: non-inferiority testing (Δ: −40mL for trough FEV1 and −0.6 points for TDI)
* p < 0.05; ** p < 0.0001; #p < 0.0001 (non-inferiority)
A1 (any SABA and/or SAMA), A2 (GLY), B1 (any LAMA or LABA and mMRC = 1), B2 (GLY and mMRC = 1)
C1 (any LABA and ICS), C2 (IND/GLY), D1 (any LAMA or LABA and mMRC > 1), D2 (IND/GLY and mMRC > 1)
CI: confidence intervals; LSM: least square means; OR: odds ratio; MCID, minimal clinically important difference