TABLE 4

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

SGRQ total score#SGRQ responders
Studies 1237.5+1237.6 common study baseline43.512±0.259
 Olodaterol 5 µg38.366±0.396427/954 (44.8)
 Tiotropium 2.5 µg37.792±0.390476/960 (49.6)
 Tiotropium 5 µg37.907±0.393465/955 (48.7)
 Tiotropium+olodaterol 2.5/5 µg37.335±0.385527/990 (53.2)
 Tiotropium+olodaterol 5/5 µg36.674±0.386563/979 (57.5)
  • Data are presented as adjusted mean±se or n/N (%). 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.