Table 6.
Subject diary ratings of breathing before and after strip application at bedtime (ITT population)
| Categorical ratingsa | VAS ratingsb | ||||||
|---|---|---|---|---|---|---|---|
| Asymmetric placebo (n = 20) | BRNS clear (n = 20) | Asymmetric butterfly (n = 19) | Asymmetric placebo (n = 20) | BRNS clear (n = 20) | Asymmetric butterfly (n = 19) | ||
| Day 1 | Day 1 | ||||||
| Mean (SD) before strip application | NA | NA | NA | Mean (SD) before strip application | 34.58 (15.80) | 27.85 (20.58) | 34.00 (14.82) |
| Mean (SD) after strip application | 1.20 (1.47) | 2.45 (1.40) | 1.42 (2.12) | Mean (SD) after strip application | 43.11 (24.07) | 61.55 (26.72) | 55.00 (24.87) |
| LS mean after strip application | 1.07 | 2.29 | 1.24 | LS mean change after vs before strip application (95% CI); P value | 7.37 (− 3.73 to 18.46); P = 0.1886 | 30.24 (19.38 to 41.10); P < 0.0001 | 19.21 (7.89 to 30.54); P = 0.0013 |
| P value for comparison with placebo | – | P = 0.0254c | P = 0.7624 | P value for comparison with placebo | – | P = 0.0032c | P = 0.1157 |
| P value for comparison with BRNS | – | – | P = 0.0546 | P value for comparison with BRNS | – | – | P = 0.1420 |
| Day 3 | Day 3 | ||||||
| Mean (SD) before strip application | NA | NA | NA | Mean (SD) before strip application | 37.95 (19.84) | 29.35 (20.30) | 45.11 (23.87) |
| Mean (SD) after strip application | 1.20 (1.36) | 2.40 (1.67) | 1.74 (1.73) | Mean (SD) after strip application | 48.53 (20.67) | 58.90 (26.64) | 61.42 (24.74) |
| LS mean after strip application | 0.96 | 2.10 | 1.39 | LS mean change after vs before strip application (95% CI); P value | 8.67 (− 1.65 to 18.99); P = 0.0978 | 23.70 (13.42 to 33.97); P < 0.0001 | 17.10 (6.26 to 27.95); P = 0.0026 |
| P value for comparison with placebo | – | P = 0.0208c | P = 0.3799 | P value for comparison with placebo | – | P = 0.0348c | P = 0.2341 |
| P value for comparison with BRNS | – | – | P = 0.1494 | P value for comparison with BRNS | – | – | P = 0.3625 |
| Day 7 | Day 7 | ||||||
| Mean (SD) before strip application | NA | NA | NA | Mean (SD) before strip application | 36.37 (21.95) | 32.10 (22.39) | 40.53 (18.23) |
| Mean (SD) after strip application | 1.20 (1.47) | 2.80 (1.40) | 1.79 (1.48) | Mean (SD) after strip application | 47.42 (26.74) | 58.95 (28.54) | 61.11 (21.79) |
| LS mean after strip application | 1.09 | 2.66 | 1.62 | LS mean change after vs before strip application (95% CI); P value | 8.75 (− 1.43 to 18.92); P = 0.0905 | 23.25 (13.21 to 33.29); P < 0.0001 | 18.89 (8.40 to 29.38); P = 0.0007 |
| P value for comparison with placebo | – | P = 0.0011c | P = 0.2497 | P value for comparison with placebo | – | P = 0.0370c | P = 0.1458 |
| P value for comparison with BRNS | – | – | P = 0.0292c | P value for comparison with BRNS | – | – | P = 0.5278 |
| Day 14 | Day 14 | ||||||
| Mean (SD) before strip application | NA | NA | NA | Mean (SD) before strip application | 43.21 (24.00) | 39.90 (24.07) | 45.89 (22.29) |
| Mean (SD) after strip application | 0.89 (1.41) | 2.70 (1.66) | 2.00 (1.72) | Mean (SD) after strip application | 51.05 (25.39) | 68.70 (26.64) | 67.56 (23.61) |
| LS mean after strip application | 0.74 | 2.54 | 1.82 | LS mean change after vs before strip application (95% CI); P value | 4.15 (− 5.70 to 14.01); P = 0.4017 | 23.52 (13.82 to 33.23); P < 0.0001 | 18.43 (8.14 to 28.72); P = 0.0007 |
| P value for comparison with placebo | – | P = 0.0009c | P = 0.0438c | P value for comparison with placebo | – | P = 0.0046c | P = 0.0385c |
| P value for comparison with BRNS | – | – | P = 0.1693 | P value for comparison with BRNS | – | – | P = 0.4483 |
BRNS Breathe Right Nasal Strip, CI confidence interval, ITT intent-to-treat, LS least square, NA not applicable; SD standard deviation, VAS visual analog scale
a Subjects rated how breathing felt after they applied the strip using a scale of − 5 = much worse, 0 = same, and 5 = much better
b VAS scale of 0 = extremely difficult to breathe to 100 = extremely easy to breathe
c Significant difference between treatments