Background
Methods
Study design
Study population and sample size
Study objectives
Study interventions, procedures and outcome measures
Evaluation of safety
Statistical methods
Results
Patients’ demographics and baseline characteristics
China | India | Indonesia | Taiwan | Thailand | All | |
---|---|---|---|---|---|---|
Patients in full analysis set | 407 | 162 | 61 | 103 | 129 | 862 |
Patients in safety analysis set | 407 | 162 | 61 | 103 | 129 | 862 |
Demographic characteristic | Number (%) of patients N = 862 | |
---|---|---|
Sex | Male | 407 (47.2) |
Female | 455 (52.8) | |
Age (years) | n | 862 |
Mean (SD) | 44.7 (13.7) | |
Range | 18 - 81 | |
Race | Asian | 862 (100.0) |
BMI (kg/m**2) | n | 862 |
Mean (SD) | 24.36 (4.10) | |
Range | 14.2 - 47.5 | |
Time since diagnosis (years) | n | 862 |
Mean (SD) | 10.73 (12.03) | |
Range | 0.1 - 60.0 | |
Smoking | Non smoker | 744 (86.3) |
Ex-smoker | 84 (9.7) | |
Occasional smoker | 18 (2.1) | |
Habitual smoker | 16 (1.9) | |
Pack-years | n | 116 |
Mean (SD) | 4.8 (2.9) | |
Range | 0 - 15 | |
Inhaled GCS at entry | No | 143 (16.6) |
Yes | 719 (83.4) | |
Inhaled GCS at entry: dose (ug/day) | n | 317 |
Mean (SD) | 557.8 (321.5) | |
Range | 50 - 1600 | |
FEV1 (L) | n | 862 |
Mean (SD) | 2.063 (0.709) | |
Range | 0.69 - 4.63 | |
FEV1% of predicted normal * | n | 862 |
Mean (SD) | 70.38 (17.37) | |
Range | 22.4 - 124.3 | |
FEV1% Reversibility | n | 862 |
Mean (SD) | 26.50 (15.15) | |
Range | 9.8 - 139.5 |
Assessments of impact on patients’ asthma control
Change in ACQ-5 score from baseline at regional level
Variable | Visit | Observed value | Change from visit 2 (baseline) | 95% CI | Paired t-test | |||||
---|---|---|---|---|---|---|---|---|---|---|
N | Mean | SD | N | Mean | SD | Lower | Upper | p-value | ||
Overall score | 2 | 854 | 1.62 | 1.00 | - | - | - | - | - | - |
3 | 833 | 1.16 | 0.88 | 826 | −0.46 | 0.96 | −0.52 | −0.39 | <.0001 | |
4 | 803 | 1.01 | 0.85 | 796 | −0.60 | 1.01 | −0.67 | −0.53 | <.0001 | |
5 | 794 | 0.92 | 0.85 | 787 | −0.69 | 1.09 | −0.77 | −0.62 | <.0001 | |
Mean of 3-5 | 841 | 1.04 | 0.75 | 834 | −0.58 | 0.93 | −0.64 | −0.51 | <.0001 |
Change in ACQ-5 score from baseline at country/area level
Overall score | N | Visit 2 (baseline) | Mean of visit 3-5 | Mean change | 95% confidence interval | Paired t-test | ||||
---|---|---|---|---|---|---|---|---|---|---|
Mean | Range | Mean | Range | Lower | Upper | p-value | ||||
Country or Area | China | 386 | 1.72 | 0.0 - 5.0 | 1.14 | 0.0 - 4.4 | −0.58 | −0.67 | −0.49 | <.0001 |
India | 159 | 1.87 | 0.0 - 5.4 | 1.12 | 0.0 - 3.3 | −0.74 | −0.92 | −0.57 | <.0001 | |
Indonesia | 61 | 1.78 | 0.0 - 3.8 | 0.61 | 0.0 - 2.9 | −1.18 | −1.40 | −0.95 | <.0001 | |
Taiwan | 100 | 1.11 | 0.0 - 4.8 | 0.89 | 0.0 - 2.9 | −0.22 | −0.38 | −0.06 | 0.0089 | |
Thailand | 128 | 1.31 | 0.0 - 3.6 | 0.95 | 0.0 - 2.9 | −0.36 | −0.48 | −0.23 | <.0001 |
Asthma symptom score, days with awakening(s) during the night, inhalations of medications, asthma-control and asthma symptom-free days
Change in forced expiratory volume in one second (FEV1) from baseline level
Variable | Visit | Observed value | Change from visit 2 (baseline) | 95% confidence interval | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
N | Mean | SD | Min | Median | Max | N | Mean | SD | Min | Median | Max | Lower | Upper | ||
FEV1 (L) | 2 | 862 | 1.964 | 0.759 | 0.40 | 1.830 | 5.06 | - | - | - | - | - | - | - | - |
3 | 836 | 2.110 | 0.779 | 0.55 | 1.985 | 4.91 | 836 | 0.152 | 0.374 | −2.35 | 0.120 | 2.01 | 0.127 | 0.178 | |
5 | 805 | 2.160 | 0.767 | 0.52 | 2.060 | 5.15 | 805 | 0.199 | 0.393 | −2.32 | 0.160 | 2.31 | 0.172 | 0.227 | |
Mean of 3 and 5 | 840 | 2.131 | 0.761 | 0.54 | 2.028 | 4.66 | 840 | 0.173 | 0.353 | −2.34 | 0.130 | 2.03 | 0.149 | 0.197 |
Assessment of impact on patients’ Quality of life
Change in AQLQ-S domains and overall scores from baseline (regional level)
Variable | Visit | Observed value | Change from visit 2 (baseline) | 95% confidence interval | Paired t-test | Wilcoxon signed rank test | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
N | Mean | SD | Min | Median | Max | N | Mean | SD | Min | Median | Max | Lower | Upper | P-value | P-value | ||
Overall score | 2 | 860 | 4.80 | 1.09 | 1.4 | 4.81 | 7.0 | - | - | - | - | - | - | - | - | - | - |
3 | 838 | 5.31 | 1.00 | 1.8 | 5.41 | 7.0 | 837 | 0.51 | 0.89 | −3.8 | 0.39 | 4.5 | 0.45 | 0.57 | <.0001 | <.0001 | |
4 | 811 | 5.54 | 0.99 | 1.7 | 5.71 | 7.0 | 810 | 0.74 | 0.95 | −2.4 | 0.59 | 4.2 | 0.67 | 0.80 | <.0001 | <.0001 | |
5 | 804 | 5.67 | 0.98 | 1.9 | 5.84 | 7.0 | 803 | 0.87 | 1.04 | −2.9 | 0.71 | 4.5 | 0.79 | 0.94 | <.0001 | <.0001 | |
Mean of 3-5 | 842 | 5.50 | 0.92 | 2.1 | 5.60 | 7.0 | 841 | 0.70 | 0.89 | −2.2 | 0.55 | 4.3 | 0.64 | 0.76 | <.0001 | <.0001 |