TABLE 4

Secondary outcomes in each of the three study arms in the intention-to-treat population at 48 weeks: change compared with baseline

PlaceboTheophylline plus placeboTheophylline plus prednisoneLeast squares means (95% CI)#
Patients554568548
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/FVC0.13±0.440.34±0.440.25±0.430.015 (−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+
 Events120101122
 Patients77 (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.