Table 1.
Patient demographics and baseline characteristics (ITT population)
| Characteristic | Ambroxol (n = 196) | Placebo (n = 194) | Total (n = 390) |
|---|---|---|---|
| Mean age, years (SD) | 37.14 (13.35) | 36.65 (12.41) | 36.90 (12.88) |
| Gender | |||
| Male, n (%) | 66 (33.7) | 70 (36.1) | 136 (34.9) |
| Female, n (%) | 130 (66.3) | 124 (63.9) | 254 (65.1) |
| Baseline pain intensity score | |||
| Mean (SD) | 7.09 (0.98) | 6.93 (0.92) | 7.01 (0.95) |
| Scores, n (%) | |||
| 6–8 | 179 (92.3) | 182 (93.8) | 361 (93.0) |
| 9–10 | 15 (7.7) | 12 (6.2) | 27 (7.0) |
| Missing | 2 | 0 | 2 |
| Duration of the acute pharyngitis, days | |||
| Mean (SD) | 2.56 (0.72) | 2.61 (0.76) | 2.59 (0.74) |
| Concomitant medicationsa, n (%) | |||
| Total | 63 (32.1) | 54 (27.8) | 117 (30.0) |
| Sex hormones and modulators of the genital system | 26 (13.3) | 23 (11.9) | 49 (12.6) |
| Analgesics | 11 (5.6) | 12 (6.2) | 23 (5.9) |
| ACEi/ARBs | 9 (4.6) | 13 (6.7) | 22 (5.6) |
| Diuretics | 8 (4.1) | 9 (4.6) | 17 (4.4) |
| Endocrine therapy | 6 (3.1) | 7 (3.6) | 13 (3.3) |
| Antidiabetic medication | 5 (2.6) | 7 (3.6) | 12 (3.1) |
ACEi angiotensin converting enzyme inhibitor, ARB angiotensin II receptor blocker, ITT intention-to- treat population, SD standard deviation
aConcomitant medications are any treatment received by the patient concomitantly with the study treatment, from the first lozenge intake to the end of treatment + 24 h