TABLE 5

St George's Respiratory Questionnaire (SGRQ) score at 24 weeks (full analysis set): treatment comparisons

Treatment comparisonSGRQ total score#p-valueResponder analysis odds ratio§,ƒp-value
Tiotropium+olodaterol 5/5 µg
versus olodaterol 5 µg−1.693±0.553 (−2.778–−0.608)0.00221.670±0.153 (1.395–1.999)<0.0001
versus tiotropium 5 µg−1.233±0.551 (−2.313–−0.153)0.02521.426±0.131 (1.192–1.706)0.0001
Tiotropium+olodaterol 2.5/5 µg
versus olodaterol 5 µg−1.031±0.552 (−2.113–0.052)0.06201.405±0.128 (1.175–1.679)0.0002
versus tiotropium 2.5 µg−0.456±0.548 (−1.531–0.618)0.40511.157±0.105 (0.969–1.383)0.1071
versus tiotropium 5 µg−0.571±0.550 (−1.649–0.507)0.29881.199±0.109 (1.004–1.433)0.0453
Tiotropium+olodaterol 5/5 µg
versus tiotropium+olodaterol 2.5/5 µg−0.662±0.545 (−1.731–0.407)0.22491.189±0.108 (0.995–1.421)0.0565
  • Data are presented as adjusted mean±se, unless otherwise stated. Data were obtained from fitting a mixed 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. #:number of patients contributing to the mixed model for repeated measurements for adjusted mean SGRQ across both studies: tiotropium+olodaterol 5/5 μg n=979; tiotropium+olodaterol 2.5/5 μg n=990; tiotropium 5 μg n=954; tiotropium 2.5 μg n=960; olodaterol 5 μg n=954; : a reduction in SGRQ total score at week 24 of ≥4.0 units from baseline. §: responder analysis results are from fitting a logistic-regression model with treatment as covariate and a logit link function; ƒ: number of patients contributing to SGRQ responder analysis across both studies: tiotropium+olodaterol 5/5 μg n=979; tiotropium+olodaterol 2.5/5 μg n=990; tiotropium 5 μg n=955; tiotropium 2.5 μg n=960; olodaterol 5 μg n=954.