TABLE 1

Demographics and baseline characteristics

Erdosteine groupPlacebo groupTotal
Patients228239467
Age years64.3±8.465.1±8.264.8±8.3
Male166 (72.8)179 (74.9)345 (73.9)
BMI kg·m−227.3±5.227.9±5.627.6±5.4
Smoking status
 Current smoker66 (28.9)69 (28.8)135 (28.8)
 Ex-smoker162 (71.1)170 (71.2)332 (71.2)
FEV1 L1.39±0.31.43±0.41.41±0.4
FEV1 % pred51.39±11.552.17±12.151.79±11.8
FVC L2.75±0.72.72±0.72.74±0.7
Post-bronchodilator FEV1/FVC ratio %52.91±10.954.52±10.953.74±10.9
Concomitant medication# for COPD
 Short-acting β2-agonists (inhalant)215 (94)217 (91)432 (93)
 Anticholinergics172 (75)183 (77)355 (76)
 Adrenergics in combination with corticosteroids102 (45)102 (43)204 (44)
 Xanthines71 (31)86 (36)157 (34)
 Glucocorticoids63 (28)71 (30)134 (29)
 Adrenergics in combination with anticholinergics13 (6)11 (5)24 (5)
 Selective β2-adrenoreceptor agonists (oral)1 (0.4)5 (2)6 (1.3)
 Other systemic drugs for obstructive airway diseases2 (0.9)1 (0.4)3 (0.6)

Data are presented as n, mean±sd or n (%). BMI: body mass index; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; COPD: chronic obstructive pulmonary disease. #: concomitant treatments have been categorised according to Anatomical Therapeutic Chemical code; : patients could have received more than one of these medications.