TABLE 2.
Baseline demographics and assessments
| Characteristic (unit) | AZM-3 (n = 312) | AZM-6 (n = 311) | AMC (n = 313) |
|---|---|---|---|
| Gender (M/F) | 123/189 | 124/187 | 134/179 |
| Age | |||
| Mean | 40.2 | 41.3 | 42.4 |
| Range | 18.0-76.0 | 18.0-80.0 | 18.0-84.0 |
| Race (n) | |||
| White | 271 | 261 | 274 |
| Black | 20 | 18 | 19 |
| Asian | 2 | 9 | 3 |
| Other | 19 | 23 | 17 |
| Ht (cm) | |||
| Mean | 170.1 | 170.2 | 171.2 |
| Range | 144.0-201.0 | 53.0-211.0 | 150.0-206.0 |
| Wt (kg) | |||
| Mean | 82.7 | 80.6 | 81.0 |
| Range | 39.0-163.3 | 35.4-154.2 | 45.4-149.7 |
| Duration of sinusitis symptoms prior to baseline (days) | 12.9 | 12.9 | 13.0 |
| Protocol-specific signs and symptoms of sinusitis present in ITT population (n [%]) | |||
| Postnasal purulent discharge | 297 (96.4) | 292 (95.4) | 292 (95.1) |
| Facial pain | 285 (92.8) | 288 (94.1) | 289 (94.5) |
| Hyposemia | 216 (70.4) | 225 (73.5) | 215 (70.0) |
| Jaw pain with mastication | 140 (45.6) | 131 (42.8) | 132 (43.0) |
| Headache | 264 (86.0) | 267 (87.3) | 271 (88.3) |
| Halitosis | 165 (53.7) | 195 (63.7) | 184 (59.9) |
| Nasal congestion | 303 (98.7) | 302 (98.7) | 302 (98.4) |
| Radiology findingsa in ITT (n [%]) | |||
| Opacification (n [%]) | 184 (59.9) | 164 (53.6) | 171 (55.7) |
| Air-fluid level (n [%]) | 98 (31.9) | 82 (26.9) | 89 (29.0) |
| ≥6-mm mucosal thickening (n [%]) | 197 (64.2) | 221 (72.2) | 208 (67.8) |
a
Subjects may have more than one finding.