Table 1—

Patient characteristics at baseline(visit three) in the two treatment groups (intention-to-treat population)

CharacteristicsPlaceboMF
Subjects7070
Female52 (74)47 (67)
Age at entry yrs
 Mean47±1145±12
 Range20–6421–67
Race
 Caucasian66 (94)66 (94)
 Other4 (6)4 (6)
FEV1 L
 Mean3.19±0.813.13 ±0.78
 Range1.68–5.411.84–5.30
FEV1 % pred
 Mean104.2±15.5103.5±13.2
 Range81–14775–133#
Reversibility of FEV1 %
 Mean3.6±2.84.4±3.8
 Range0.0–10.00.0–22.0
Mean±sem morning PEF L·min−1461±13436±13
Mean±sem evening PEF L·min−1468±13444±13
PEF variability5.4±3.25.5±3.8
Salbutamol puffs·day−10.44±0.860.94±0.14
BHR+14/3421/36
Atopy§65/7069/70
Rhinitis
 History of allergic rhinitis1218
 Actual use of nasal steroids1320
Sputum eosinophils
 Score 0–1 (<5%)4641
 Score 2–4 (≥5%)811
Sputum ECP µg·L−1714±1343962±1654
  • Data are presented as n, n (%) or mean±sd, unless otherwise stated. MF: mometasone furoate; FEV1: forced expiratory volume in one second; PEF: peak expiratory flow; BHR: bronchial hyperresponsiveness; ECP: eosinophilic cationic protein. #: one patient had an FEV1 <80% predicted at baseline (visit three). At visit two (the screening visit) all patients fulfilled the inclusion criterion of a FEV1 >80% pred; : one patient showed a reversibility of FEV1 of >12% at baseline (visit three). At visit two (the screening visit) all patients fulfilled the inclusion criterion of a reversibility of <12%. +: number of hyperresponsive/number of tested subjects; §: number of skin-prick test positive/number of tested patients.