Parameter | Group 1 (n=36) | Group 2 (n=64) | Group 1 vs. 2 | |||
baseline | 28 weeks | baseline | 28 weeks | p-Value | ||
Patients with ≥1 exacerbation | 9.5% | 0.0% | 9.3% | 1.1% | 0.530 | |
Patients missing any day at work/college | 23.8% | 0.0% | 25.9% | 7.4% | 0.200 | |
Hospitalization rate | 19.0% | 0.0% | 27.8% | 0.0% | - | |
D vs. baseline | p-Value | D vs. baseline | p-Value | Mean difference | p-Value | |
FEV1 (L) | +1.1 | 0.000 | +1.0 | 0.000 | 0.1 | 0.244 |
ACQ5 score (composite) | -7.5 | 0.000 | -7.3 | 0.000 | -0.2 | 0.786 |
ACQ5 score (mean) | -1.5 | 0.000 | -1.5 | 0.000 | 0.0 | 0.981 |
ACT score(mean) | +9.4 | 0.000 | +10.2 | 0.000 | -0.8 | 0.396 |
OCS dose (mg/day) | -11.3† | 0.002 | -18.8‡ | 0.000 | 7.5 | 0.099 |
* †13 and ‡16 patients were receiving OCS at baseline in group 1 and 2, respectively.