TABLE 1

Baseline characteristics of the patients in the intention-to-treat population

TotalPlaceboTheophylline plus placeboTheophylline plus prednisone
Patients1670554568548
Age years64.4±8.063.9±8.564.4±7.864.9±7.7
Male1264 (75.7)426 (76.9)434 (76.4)404 (73.7)
BMI kg·m2#22.3±3.522.4±3.522.3±3.522.3±3.5
Smoking status#
 Current smoker332 (19.9)98 (17.7)121 (21.3)113 (20.6)
 Ex-smoker889 (53.3)309 (55.8)299 (52.7)281 (51.3)
 Never-smoker448 (26.8)147 (26.5)147 (25.9)154 (28.1)
Pack-years
 Current smoker42.7±23.943.5±27.140.5±22.344.4±22.7
 Ex-smoker38.2±20.839.3±22.738.5±19.836.7±19.6
Spirometry
 Pre-BD FEV1 L1.0±0.41.0±0.41.0±0.40.9±0.4
 Post-BD FEV1 L1.1±0.41.1±0.41.1±0.41.0±0.4
 Post-BD FEV1 % pred42.2±15.842.1±15.543.0±15.841.6±15.9
 Post-BD FEV1/FVC0.480.480.460.43
GOLD severity of airflow limitation
 Mild22 (1.3)5 (0.9)12 (2.1)5 (0.9)
 Moderate429 (25.8)146 (26.7)152 (26.8)131 (23.9)
 Severe821 (49.4)265 (48.4)279 (49.2)277 (50.6)
 Very severe389 (23.4)131 (23.9)124 (21.9)134 (24.5)
Prior year exacerbation rate+0.7±1.00.7±1.10.7±1.00.7±1.1
Dust and fume exposure#286 (17.1)97 (17.5)99 (17.5)90 (16.4)
Biomass exposure#641 (38.4)209 (37.7)214 (37.8)218 (39.8)
CAT score18.1±7.418.3±7.417.8±7.618.1±7.3
SGRQ total score45.8±20.146.5±19.944.8±20.746.2±19.5
Total white blood cells ×109 L−1#6.7±2.26.8±2.16.7±2.26.8±2.2
 Eosinophils ×109 L−10.3±0.60.3±0.70.3±0.70.3±0.5

Data are presented as n, mean±sd or n (%). BMI: body mass index; BD: bronchodilator; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; GOLD: Global Initiative for Chronic Obstructive Lung Disease; CAT: COPD Assessment Test; COPD: chronic obstructive pulmonary disease; SGRQ: St George's Respiratory Questionnaire. #: at screening (≤2 weeks from baseline); : 15 min following 400 mg salbutamol; +: exacerbation defined as a worsening of respiratory symptoms necessitating the use of antibiotics, oral corticosteroids or both in the year prior to randomisation.