Average, peak and trough response in forced expiratory volume in one second(FEV1) and forced vital capacity (FVC), and the comparison between treatment regimens
| Variable | Average# | Peak | Trough | ||
| 0–12 h | 0–24 h | 12–24 h | |||
| FEV1 response L | |||||
| T | 0.127±0.01 | 0.085±0.01 | 0.043±0.01 | 0.220±0.01 | 0.100±0.02 |
| F | 0.086±0.01 | 0.062±0.01 | 0.038±0.01 | 0.223±0.01 | 0.059±0.02 |
| T+F | 0.234±0.01 | 0.160±0.01 | 0.086±0.01 | 0.354±0.01 | 0.138±0.02 |
| T+F versus T | 0.107 (0.072–0.142) | 0.075 (0.042–0.108) | 0.043 (0.008–0.079) | 0.134 (0.094–0.175) | 0.037 (-0.005–0.079) |
| p-value | <0.0001 | <0.0001 | <0.02 | <0.0001 | 0.08 |
| T+F versus F | 0.147 (0.112–0.182) | 0.098 (0.065–0.131) | 0.048 (0.013–0.084) | 0.131 (0.090–0.171) | 0.079 (0.037–0.121) |
| p-value | <0.0001 | <0.0001 | <0.01 | <0.0001 | <0.0005 |
| T versus F | 0.040 (0.006–0.075) | 0.023 (-0.010–0.056) | 0.005 (-0.030–0.041) | -0.004 (-0.044–0.036) | 0.042 (0.000–0.083) |
| p-value | <0.03 | 0.17 | 0.77 | 0.86 | <0.05 |
| FVC response L | |||||
| T | 0.234±0.02 | 0.155±0.02 | 0.076±0.03 | 0.430±0.03 | 0.157±0.03 |
| F | 0.147±0.02 | 0.091±0.02 | 0.036±0.03 | 0.437±0.03 | 0.083±0.03 |
| T+F | 0.414±0.02 | 0.274±0.02 | 0.133±0.03 | 0.678±0.03 | 0.234±0.03 |
| T+F versus T | 0.180 (0.117–0.242) | 0.118 (0.057–0.180) | 0.057 (-0.013–0.127) | 0.249 (0.169–0.328) | 0.078 (0.002–0.153) |
| p-value | <0.0001 | 0.0002 | 0.11 | <0.0001 | <0.05 |
| T+F versus F | 0.267 (0.204–0.330) | 0.182 (0.120–0.244) | 0.097 (0.027–0.168) | 0.242 (0.161–0.322) | 0.151 (0.076–0.227) |
| p-value | <0.0001 | <0.0001 | <0.01 | <0.0001 | <0.001 |
| T versus F | 0.088 (0.025–0.150) | 0.064 (0.003–0.125) | 0.040 (-0.029–0.110) | -0.007 (-0.086–0.072) | 0.074 (-0.001–0.148) |
| p-value | <0.01 | <0.05 | 0.25 | 0.86 | 0.054 |
Data are presented as mean±se and mean (95% confidence interval), unless otherwise stated. Means are adjusted for period, centre and patient within centre. T: tiotropium q.d.; F: formoterol b.i.d.; T+F: tiotropium plus formoterol q.d.#: the average was calculated as the area under the curve from zero time to 12 or 24 h (or 12–24 h), respectively, using the trapezoidal rule divided by the corresponding duration (i.e. 12 or 24 h) to give the result in litres.