Table 2.
Efficacy endpoints Least Squares Means full analysis set
| Placebo | AZD7594 58μg | AZD7594 250μg | AZD7594 800μg | |
|---|---|---|---|---|
| (n = 52) | (n = 34) | (n = 34) | (n = 34) | |
| Primary efficacy endpoint | ||||
| Morning pre‐bronchodilator FEV1 | ||||
| Change from baseline (L) on day 15 | 0.059 | 0.086 | 0.136 | 0.207 |
| Treatment difference (L) (95% CI) | N.A. | 0.027 (‐0.086, 0.140) | 0.076 (‐0.036, 0.188) | 0.148 (0.035, 0.261) |
| P value | N.A. | 0.638 | 0.183 | 0.011 |
| Key secondary efficacy endpoints | ||||
| Morning pre‐bronchodilator FEV1 | ||||
| Change from baseline (L) on day 8 | 0.071 | 0.102 | 0.089 | 0.227 |
| Treatment difference (L) (95% CI) | N.A. | 0.031 (‐0.086, 0.147) | 0.017 (‐0.010, 0.134) | 0.156 (0.039, 0.273) |
| P value | N.A. | 0.604 | 0.767 | 0.009 |
| Key secondary efficacy endpoints | ||||
| Morning pre‐bronchodilator FEV1 | ||||
| Change from baseline (L) on day 8 | 0.071 | 0.102 | 0.089 | 0.227 |
| Treatment difference (L) (95% CI) | N.A. | 0.031 (‐0.086, 0.147) | 0.017 (‐0.010, 0.134) | 0.156 (0.039, 0.273) |
| P value | N.A. | 0∙604 | 0∙767 | 0∙009 |
| Fraction exhaled nitric oxide (FENO) | ||||
| Change from baseline (ppb) on day 8 | ‐4.296 | ‐9.153 | ‐14.71 | ‐19.04 |
| Treatment difference (ppb) (95% CI) | N.A. | ‐4.857 (‐11.24, 1.528) | ‐10.41 (‐16.75, ‐4.075) | ‐14.75 (‐21.18, ‐8.319) |
| P value | N.A. | 0.134 | 0.002 | <0.0001 |
| Change from baseline (ppb) on day 15 | ‐0.549 | ‐14.40 | ‐14.81 | ‐20.44 |
| Treatment difference (ppb) (95% CI) | N.A. | ‐13.85 (‐24.06, ‐3.642) | ‐14.26 (‐24.37, ‐4.149) | ‐19.90 (‐30.10, ‐9.689) |
| P value | N.A. | 0.008 | 0.006 | 0.0002 |
| Morning peak expiratory flow (mPEF) | ||||
| Change from baseline Day 1‐14 | 0.0814 | 10.42 | 5.334 | 12.60 |
| Treatment difference (L/min) (95% CI) | N.A. | 10.34 (‐1.335, 22.01) | 5.253 (‐6.427, 16.93) | 12.52 (0.748, 24.29) |
| P value | N.A. | 0.082 | 0.374 | 0.037 |
| Evening peak expiratory flow (ePEF) | ||||
| Change from baseline Day 1‐14 | ‐8.257 | 7.475 | 6.04 | 11.65 |
| Treatment difference (L/min) (95% CI) | N.A. | 15.73 (5.039, 26.43) | 14.30 (3.534, 25.06) | 19.91 (9.068, 30.75) |
| P value | N.A. | 0.004 | 0.010 | 0.0004 |
| Forced vital capacity (FVC) | ||||
| Change from baseline (L) on day 8 | 0.0844 | 0.062 | 0.084 | 0.153 |
| Treatment difference (L) (95% CI) | N.A. | ‐0.023 (‐0.137, 0.091) | ‐0.0003 (‐0.115, 0.114) | 0.068 (‐0.046, 0.183) |
| P value | N.A. | 0.694 | 0.996 | 0.240 |
| Change from baseline (L) on day 15 | 0.0765 | 0.042 | 0.104 | 0.138 |
| Treatment difference (L) (95% CI) | N.A. | ‐0.035 (‐0.141, 0.072) | 0.028 (‐0.078, 0.134) | 0.062 (‐0.045, 0.168) |
| P value | N.A. | 0.521 | 0.598 | 0.254 |
| Asthma symptom score | ||||
| Change from baseline day 1 ‐ 14 | ‐0.012 | ‐0.119 | ‐0.094 | 0.215 |
| Treatment difference (95% CI) | N.A. | ‐0.107 (‐0.206, ‐0.008) | ‐0.082 (‐0.182, 0.018) | ‐0.203(‐0.303, ‐0.103) |
| P value | N.A. | 0.035 | 0.105 | 0.0001 |
| Asthma symptom free days | ||||
| Change from baseline day 1 ‐ 14 | 0.050 | 0.603 | 0.318 | 1.01 |
| Treatment difference (95% CI) | N.A. | 0.553 (0.036, 1.069) | 0.268 (‐0.252, 0.788) | 0.956 (0.433, 1.48) |
| P value | N.A. | 0.036 | 0.308 | 0.0005 |
| Asthma control days | ||||
| Change from baseline day 1 ‐ 14 | 0.277 | 0.950 | 0.705 | 1.219 |
| Treatment difference (95% CI) | N.A. | 0.673 (0.088, 1.258) | 0.428 (‐0.161, 1.017) | 0.942 (0.348, 1.535) |
| P value | N.A. | 0.025 | 0.152 | 0.002 |
| ACQ‐5 day 15 | ||||
| Change from baseline | 0.014 | ‐0.293 | ‐0.168 | ‐0.416 |
| Treatment difference (95% CI) | N.A. | ‐0.307 (‐0.516, ‐0.098) | ‐0.182 (‐0.393, 0.028) | ‐0.430 (‐0.640, ‐0.221) |
| P value | N.A. | 0.004 | 0.088 | <0.0001 |
| Rescue medication use (day 1 – 14) | ||||
| Change from baseline (inhalations) per day | ‐0.334 | ‐0.678 | ‐0.819 | ‐1.137 |
| Treatment difference (95% CI) | N.A. | ‐0.344 (‐0.719, 0.0318) | ‐0.485 (‐0.863, ‐0.1073) | ‐0.803 (‐1.183, ‐0.422) |
| P value | N.A. | 0.072 | 0.012 | <0.0001 |
| Nighttime awakenings | ||||
| Change from baseline day 1‐ 14 | 0.007 | ‐0.412 | ‐0.173 | ‐0.760 |
| Treatment difference (95% CI) | N.A. | ‐0.419 (‐0.741, ‐0.956) | ‐0.179 (‐0.503, 0.144) | ‐0.766 (‐1.091, ‐0.441) |
| P value | N.A. | 0.0116 | 0.273 | <0.0001 |
ACQ‐5 Asthma Control Questionnaire‐5, CI confidence interval, FEV1 forced expiratory volume in 1 second, L liters, ppb parts per billion