Analysis of key efficacy parameters at day 4
| Key efficacy assessments | CS1002 | Simple linctus |
|---|---|---|
| Number of participants | 82 | 75 |
| Cough severity | ||
| Baseline value (mean±SD) | 80.4 (10.1) | 81.6 (9.9) |
| Change from baseline to day 4: mean ( 95% CI) | −38.9 (−45.2 to −33.2) | −32.8 (−39.6 to −27.0) |
| Adjusted mean difference (95% CI) | −5.9 (−14.4 to 2.7) | |
| p Value (between groups) | p=0.18 | |
| Cough frequency | ||
| Baseline value (mean±SD) | 79.5 (16.1) | 76.7 (15.5) |
| Change from baseline to day 4: mean ( 95% CI) | −40.7 (−46.0 to −34.6) | −32.1 (−38.1 to −26.4) |
| Adjusted mean difference (95% CI) | −8.1 (−16.2 to 0.1) | |
| p Value (between groups) | p=0.05 | |
| Cough resolution | ||
| Day 4 value (n, %) | 24 (29.3%) | 13 (17.3) |
| Difference (%) | 12% | |
| p Value (between groups) | p=0.08 | |
| Sleep disruption | ||
| Baseline value (mean±SD) | 75.5 (23.2) | 64.6 (29.2) |
| Change from baseline to day 4; mean ( 95% CI) | −42.8 (−46.9 to −34.4) | −26.3 (−35.5 to −22.6) |
| Adjusted mean difference (95% CI) | −11.6 (−20.6 to −2.7) | |
| p Value (between groups) | p=0.01 | |
Based on intention-to-treat (ITT) population.
Negative values indicate a reduction in cough symptoms.
Adjusted mean difference, difference in between group differences. Cough severity, frequency and sleep disruption measured on a visual analogue scale (0-100 mm) Bold signifies p values.