Table 1.
Patient baseline demographic and clinical characteristics*
| Variable | Treatment (n = 201) | Control (n = 99) |
|---|---|---|
| Age (years) | 50.5 ± 12.9 | 47.9 ± 12.4 |
| Male subjects, n (%) | 127 (63.2) | 56 (56.6) |
| Race, n (%) | ||
| White | 164 (81.6) | 80 (80.8) |
| Black | 27 (13.4) | 13 (13.1) |
| Asian | 4 (2.0) | 4 (4.0) |
| Other | 6 (3.0) | 2 (2.0) |
| CRS symptoms despite ongoing use of INCS, n (%) | ||
| Nasal obstruction/blockage | 185 (92.0) | 90 (90.9) |
| Postnasal discharge | 182 (90.5) | 83 (83.8) |
| Altered sense of smell/taste | 174 (86.6) | 89 (89.9) |
| Facial pain/pressure/fullness | 77 (38.3) | 44 (44.4) |
| ESS history, n (%) | ||
| Number of prior ESS | ||
| 1 | 83 (41.3) | 41 (41.4) |
| 2 | 57 (28.4) | 36 (36.4) |
| 3 | 32 (15.9) | 7 (7.1) |
| ≥4 | 29 (14.4) | 15 (15.2) |
| Indicated for repeat ESS | 201 (100) | 99 (100) |
| Medical history, n (%)a | ||
| Allergic rhinitis | 155 (77.1) | 79 (79.8) |
| Mild | 52 (25.9) | 23 (23.2) |
| Moderate | 78 (38.8) | 43 (43.4) |
| Severe | 25 (12.4) | 13 (13.1) |
| Asthma | 148 (73.6) | 61 (61.6) |
| Mild | 84 (41.8) | 31 (31.3) |
| Moderate | 56 (27.9) | 26 (26.3) |
| Severe | 8 (4.0) | 4 (4.0) |
| AERD | 30 (14.9) | 17 (17.2) |
| Smoking | ||
| Never smoked | 130 (64.7) | 69 (69.7) |
| Former smoker | 65 (32.3) | 24 (24.2) |
| Current smoker | 6 (3.0) | 6 (6.1) |
| Symptomatic findings | ||
| Nasal obstruction/congestion score ≥2 on 5 of 7 days, n (%) | 201 (100) | 99 (100) |
| Nasal obstruction/congestion score (scale 0 to 3) | 2.4 ± 0.5 | 2.4 ± 0.5 |
| Decreased sense of smell score (scale 0 to 5) | 4.1 ± 1.4 | 4.1 ± 1.4 |
| Facial pain/pressure score (scale 0 to 5) | 1.9 ± 1.4 | 2.2 ± 1.4 |
| Endoscopic findings by an independent reviewer | ||
| Polyp grade ≥2 on each side (scale 0 to 4), n (%) | 201 (100) | 99 (100) |
| Bilateral polyp grade (scale 0 to 8) | 5.95 ± 0.94 | 5.87 ± 1.00 |
*Values are means ± SD or as indicated. Only incidence of asthma (mainly mild) differed significantly between the groups (p = 0.0336).
aMedical history based on physician diagnosis as recorded in patient medical records.
AERD = aspirin exacerbated respiratory disease; CRS = chronic rhinosinusitis; ESS = endoscopic sinus surgery; INCS = intranasal corticosteroid sprays; SD = standard deviation.