Secondary outcomes in each of the three study arms in the intention-to-treat population at 48 weeks: change compared with baseline
| Placebo | Theophylline plus placebo | Theophylline plus prednisone | Least squares means (95% CI)# | |
| Patients | 554 | 568 | 548 | |
| Change in post-BD spirometry# | ||||
| FEV1 L | −0.02±0.01 | −0.01±0.01 | −0.02±0.01 | −0.002 (−0.034–0.029) |
| FEV1/FVC | 0.13±0.44 | 0.34±0.44 | 0.25±0.43 | 0.015 (−1.023–1.053) |
| Change in CAT score | −2.29±0.33 | −2.77±0.33 | −2.57±0.33 | −0.043 (−0.830–0.744) |
| Change in SGRQ score | −4.95±0.91 | −6.85±0.91 | −6.48±0.89 | −0.58 (−2.73–1.58) |
| SAE hospitalisations+ | ||||
| Events | 120 | 101 | 122 | |
| Patients | 77 (13.9) | 71 (12.5) | 73 (13.3) |
Data are presented as n, mean±sd or n (%), unless otherwise stated. BD: bronchodilator; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; CAT: COPD Assessment Test; COPD: chronic obstructive pulmonary disease; SGRQ: St George's Respiratory Questionnaire; SAE: serious adverse event. #: analysis was performed between the theophylline plus prednisone arm and the pooled theophylline plus placebo and placebo arms.