Table 2.
Disease characteristics measured during reversibility testing and at baseline (treated set)
| Reversibility testing | ||||||
|---|---|---|---|---|---|---|
| Pre-bronchodilator a | Post-bronchodilator b | Baseline pre-dose c | ||||
| Mean | SD | Mean | SD | Mean | SD | |
| FEV1 | ||||||
| Predicted normal, L | 1.928 | 0.416 | ||||
| Actual, L | 1.539 | 0.385 | 1.909 | 0.469 | 1.640 | 0.386 |
| Actual, % predicted normal | 79.661 | 8.142 | 98.908 | 11.024 | 85.392 | 10.711 |
| Reversibility, mLd | 370 | 171 | ||||
| Reversibility, % of pre-bronchodilatore | 24.578 | 12.106 | ||||
| Variation, %f | 7.60 | 12.43 | ||||
| FVC | 2.233 | 0.519 | ||||
| Predicted normal, L | 2.059 | 0.567 | 2.341 | 0.611 | ||
| Actual, L | 92.266 | 13.339 | 105.080 | 15.560 | 2.127 | 0.545 |
| Actual, % predicted normal | 75.830 | 9.623 | 82.404 | 8.817 | 95.844 | 15.067 |
| FEV1/FVC, % | 78.109 | 9.467 | ||||
| PEF, L/min | 220 | 56 | ||||
| ICS maintenance dose, μg (budesonide or equivalent dose) | 282.2 | 85.8 | ||||
aMeasured 10 minutes prior to inhalation of two puffs of salbutamol (100 μg per puff) at screening (Visit 1); bMeasured 15–30 minutes after inhalation of two puffs of salbutamol (100 μg per puff) at screening (Visit 1); cMeasured 10 minutes prior to inhalation of study medication at baseline (Visit 2); dCalculated as FEV1 post-bronchodilator – FEV1 pre-bronchodilator; eCalculated as 100 × (FEV1 post-bronchodilator/FEV1 pre-bronchodilator) – 1; fCalculated as 100 × (FEV1 at baseline/pre-bronchodilator FEV1 at screening) – 1. FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICS, inhaled corticosteroids; PEF, peak expiratory flow; SD, standard deviation.