Subject demographics and baseline characteristics
| Evaluable population | Modified intent-to-treat population | |||
| Placebo | Fexofenadine HCl 180 mg | All | ||
| Subjects | 257 | 125 | 126 | 251 |
| Age years | 40.8±0.78 | 41.5±1.12 | 40.0±1.12 | 40.7±0.79 |
| Sex | ||||
| Male | 90 (35.0) | 37 (29.6) | 49 (38.9) | 86 (34.3) |
| Female | 167 (65.0) | 88 (70.4) | 77 (61.1) | 165 (65.7) |
| Smoking status | ||||
| Never smoked | 173 (67.3) | 77 (61.6) | 92 (73.0) | 169 (67.3) |
| Quit smoking | 52 (20.2) | 30 (24.0) | 22 (17.5) | 52 (20.7) |
| Currently smokes | 32 (12.5) | 18 (14.4) | 12 (9.5) | 30 (12.0) |
| Allergic medical history | ||||
| Seasonal allergic rhinitis | 257 (100.0) | 125 (100.0) | 126 (100.0) | 251 (100.0) |
| Perennial allergic rhinitis | 183 (71.2) | 85 (68.0) | 92 (73.0) | 177 (70.5) |
| Mean allergen wheal diameter mm | ||||
| Control | 0.5±0.06 | 0.5±0.09 | 0.4±0.07 | 0.5±0.06 |
| Ragweed | 12.4±0.4 | 11.9±0.47 | 12.9±0.62 | 12.4±0.39 |
| TNSS | ||||
| Period 1 (H0)# | 0.5±0.05 | |||
| 95% CI for the mean | 0.40–0.62 | |||
| Median (interquartile range) | 0 (0.0–1.0) | |||
| Range | 0–5 | |||
| Period 2 (H0)# | 0.5±0.06 | |||
| 95% CI for the mean | 0.39–0.61 | |||
| Median (interquartile range) | 0 (0.0–1.0) | |||
| Range | 0–5 | |||
| Period 3 (H2)# | 6.2±0.20 | 5.6±0.18 | ||
| 95% CI for the mean | 5.77–6.55 | 5.27–6.00 | ||
| Median (interquartile range) | 6.0 (5.0–8.0) | 6.0 (4.0–7.0) | ||
| Range | 0–9 | 0–9 | ||
Data are presented as n, mean±se or n (%). Percentages are calculated from non-missing data. #: For Period 1 and Period 2, the baseline is defined as the value at H0 (start of challenge), for Period 3 baseline is defined as the last available value after challenge and before treatment administration. TNSS: total nasal symptom score.