Table 1.
Patient Baseline Clinical Characteristics.
| EDS-placebo BIDn = 82 | EDS-FLU 93 µg BIDn = 81 | EDS-FLU 186 µg BIDn = 80 | EDS-FLU 372 µg BIDn = 80 | All Patients N = 323 | |
|---|---|---|---|---|---|
| Age in years (SD) | 45.3 (12.95) | 44.9 (12.72) | 46.4 (12.65) | 43.9 (12.63) | 45.1 (12.71) |
| Minimum, maximum | 18, 74 | 18, 68 | 18, 71 | 18, 73 | 18, 74 |
| Men (%) | 36 (43.9) | 40 (49.4) | 48 (60.0) | 38 (47.5) | 162 (50.2) |
| Comorbid asthma n (%) | 33 (40.2) | 23 (28.4) | 38 (47.5) | 40 (50.0) | 134 (41.5) |
| White race (%) | 68 (82.9) | 74 (91.4) | 72 (90.0) | 69 (86.3) | 283 (87.6) |
| Any corticosteroid for nasal polyps in last 10 years (%) | 77 (93.9) | 77 (95.1) | 76 (95.0) | 75 (93.8) | 305 (94.4) |
| Any corticosteroid for nasal polyps in last 30 days (%) | 48 (58.5) | 35 (43.2) | 36 (45.0) | 40 (50.0) | 159 (49.2) |
| Previous sinus surgery and polyp removal | 52 (63.4) | 49 (60.5) | 47 (58.8) | 47 (58.8) | 195 (60.4) |
| Instantaneous am congestion scores (SD) | 2.31 (0.412) | 2.22 (0.445) | 2.24 (0.416) | 2.29 (0.438) | 2.25 (0.432) |
| Mean bilateral total polyp score (SD) | 3.8 (0.94) | 3.6 (1.07) | 3.9 (1.08) | 3.7 (0.94) | 3.7 (1.04) |
| Mean SNOT-22 total scores (SD) | 53.7 (18.12) | 46.1 (17.80) | 51.8 (20.07) | 52.4 (20.07) | 51.02 |
| Mean MOS Sleep-R Sleep disturbance subscale scores (SD) | 40.4 (22.31) | 33.6 (21.07) | 46.6 (22.01) | 41.5 (23.26) | 42.72 |
| Meet surgical evaluation criteria, n/N (%) | 53/82 (64.6) | 45/81 (55.6) | 44/80 (55.0) | 47/78 (60.3) | 58.88 |
Abbreviations: am, morning; BID, twice daily; EDS-FLU, exhalation delivery system with fluticasone; MOS, Medical Outcomes Study; N, total of number of patients randomized/enrolled/treated; n/N (%), number (%) of patients in the subset at the given time point; SD, standard deviation; SNOT-22, Sinonasal Outcome Test-22.
Baseline instantaneous am congestion, polyp grade, SNOT-22, MOS Sleep-R, and surgical evaluation data are from the Full Analysis Set, whereas other data are from the intention-to-treat population.