TABLE 3

Time to first (mild, moderate or severe) chronic obstructive pulmonary disease (COPD) exacerbation in the intention-to-treat population#

Placebo (arm 1)Theophylline plus placebo (arm 2)Theophylline plus prednisone (arm 3)Hazard ratio (95% CI)p-value
Patients554568548
Time to first COPD exacerbation days232233229
 Median (IQR)137 (58.5–233.5)150 (66.0–242.0)151 (71.0–247.0)
Had ≥1 COPD exacerbations232 (41.9)233 (41.0)229 (41.8)0.95
Hazard ratio (95% CI)#
 Arm 3 versus (arm 1+2)0.92 (0.79–1.08)0.32
 Arm 3 versus arm 10.90 (0.75–1.08)0.25
 Arm 3 versus arm 20.95 (0.79–1.14)0.56
 Arm 2 versus arm 10.95 (0.79–1.14)0.57

Data are presented as n or n (%), unless otherwise stated. IQR: interquartile range. #: adjusted for hospital region, history of smoking, sex, exacerbation in the year prior to randomisation and post-bronchodilator forced expiratory volume in 1 s % predicted at screening.