Table 2.
SGRQ total score and responders at Week 24 in the Japanese and overall populations (full analysis set, combined studies)
| Treatment | Japanese population (combined studies) (n=413) |
Overall population (combined studies) (n=4,837) |
||||
|---|---|---|---|---|---|---|
| Adjusted mean (SE) | Change from baseline | Responders, %a | Adjusted mean (SE) | Change from baseline | Responders, %a | |
| Common baseline | 33.71 (0.79) | 43.51 (0.26) | ||||
| Olodaterol 5 μg | 30.12 (0.99) | −3.59 | 36.9 | 38.37 (0.40) | −5.09 | 44.8 |
| Tiotropium 2.5 μg | 31.10 (1.18) | −2.62 | 35.3 | 37.79 (0.39) | −5.67 | 49.6 |
| Tiotropium 5 μg | 30.40 (1.08) | −3.32 | 40.5 | 37.91 (0.39) | −5.55 | 48.7 |
| Tiotropium + olodaterol 2.5/5 μg | 28.15 (1.11) | −5.56 | 55.3 | 37.34 (0.39) | −6.12 | 53.2 |
| Tiotropium + olodaterol 5/5 μg | 26.79 (1.16) | −6.92 | 57.9 | 36.67 (0.39) | −6.79 | 57.5 |
| Japanese population (combined studies)
|
Overall population (combined studies)
|
|||
|---|---|---|---|---|
| Adjusted mean (SE) treatment differenceb | 95% CI | Adjusted mean (SE) treatment difference | 95% CI | |
| Tiotropium + olodaterol 5/5 μg | ||||
| vs olodaterol 5 μg | −3.33 (1.53)* | −6.33, −0.33 | −1.69 (0.55)** | −2.78, −0.61 |
| vs tiotropium 5 μg | −3.60 (1.58)* | −6.71, −0.50 | −1.23 (0.55)* | −2.31, −0.15 |
| Tiotropium + olodaterol 2.5/5 μg | ||||
| vs olodaterol 5 μg | −1.97 (1.49) | −4.89, 0.95 | −1.03 (0.55) | −2.11, 0.05 |
| vs tiotropium 2.5 μg | −2.95 (1.62) | −6.13, 0.24 | −0.46 (0.55) | −1.53, 0.62 |
Notes: Adjusted mean (SE) obtained from fitting a mixed-effects model for repeated measurements including fixed effects of treatment, planned test day, treatment-by-test-day interaction, baseline, and baseline-by-test-day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward–Roger approximation of denominator degrees of freedom.
Defined as having an SGRQ total score at Week 24 improved by ≥4.0 units over baseline SGRQ total score; responder analysis results are from fitting a logistic regression model with treatment as covariate and a logit link function. Number of patients contributing to SGRQ analysis in the Japanese population: olodaterol 5 μg n=103, tiotropium 2.5 μg n=68, tiotropium 5 μg n=74, tiotropium + olodaterol 2.5/5 μg n=76, tiotropium + olodaterol 5/5 μg n=76. Number of patients contributing to the SGRQ analysis in the overall population: olodaterol 5 μg n=954, tiotropium 2.5 μg n=960, tiotropium 5 μg n=954 (n=955 for the responder analysis), tiotropium + olodaterol 2.5/5 μg n=990, tiotropium + olodaterol 5/5 μg n=979;
nominal P-value.
P<0.05;
P<0.01.
Abbreviations: SGRQ, St George’s Respiratory Questionnaire; SE, standard error; CI, confidence interval.