Table 5.
Subject diary ratings of nasal stuffiness 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 | ||||||
| Mean (SD) before strip application | 2.00 (0.56) | 1.95 (0.39) | 1.79 (0.54) | 37.74 (17.14) | 27.90 (20.46) | 35.89 (14.64) |
| Mean (SD) after strip application | 1.80 (0.70) | 1.10 (0.79) | 1.26 (0.56) | 45.84 (23.06) | 61.45 (25.85) | 57.68 (22.58) |
| LS mean change after vs before strip application (95% CI); P value | − 0.11 (− 0.40 to 0.18); P = 0.4637 | − 0.77 (− 1.06 to − 0.47); P < 0.0001 | − 0.50 (− 0.81 to − 0.19); P = 0.0019 | 7.66 (− 2.93 to 18.25); P = 0.1528 | 29.10 (18.73 to 39.47); P < 0.0001 | 18.80 (7.86 to 29.74); P = 0.0011 |
| P value for comparison with placebo | – | P = 0.0016c | P = 0.0580 | – | P = 0.0040c | P = 0.1236 |
| P value for comparison with BRNS | – | – | P = 0.1986 | – | – | P = 0.1561 |
| Day 3 | ||||||
| Mean (SD) before strip application | 1.90 (0.55) | 1.90 (0.64) | 1.58 (0.69) | 38.32 (19.29) | 30.05 (20.41) | 46.42 (24.13) |
| Mean (SD) after strip application | 1.60 (0.75) | 1.16 (0.90) | 1.16 (0.69) | 49.74 (22.10) | 59.25 (27.47) | 62.16 (24.85) |
| LS mean change after vs before strip application (95% CI); P value | − 0.20 (− 0.51 to 0.11); P = 0.2047 | − 0.66 (− 0.99 to − 0.33); P = 0.0002 | − 0.41 (− 0.75 to − 0.07); P = 0.0176 | 9.40 (− 1.23 to 20.04); P = 0.0819 | 23.50 (12.86 to 34.13); P < 0.0001 | 16.75 (5.57 to 27.93); P = 0.0040 |
| P value for comparison with placebo | – | P = 0.0377c | P = 0.3447 | – | P = 0.0539 | P = 0.3152 |
| P value for comparison with BRNS | – | – | P = 0.2733 | – | – | P = 0.3678 |
| Day 7 | ||||||
| Mean (SD) before strip application | 1.70 (0.73) | 1.75 (0.55) | 1.63 (0.60) | 37.74 (22.42) | 30.75 (21.75) | 42.05 (21.37) |
| Mean (SD) after strip application | 1.55 (0.89) | 1.00 (0.80) | 1.16 (0.69) | 48.63 (26.87) | 60.85 (27.31) | 64.95 (21.71) |
| LS mean change after vs before strip application (95% CI); P value | − 0.12 (− 0.38 to 0.14); P = 0.3512 | − 0.71 (− 0.97 to − 0.45); P < 0.0001 | − 0.44 (− 0.71 to − 0.16); P = 0.0022 | 8.62 (− 1.40 to 18.64); P = 0.0903 | 25.43 (15.50 to 35.35); P < 0.0001 | 21.43 (11.08 to 31.79); P = 0.0001 |
| P value for comparison with placebo | – | P = 0.0015c | P = 0.0815 | – | P = 0.0153c | P = 0.0635 |
| P value for comparison with BRNS | – | – | P = 0.1345 | – | – | P = 0.5600 |
| Day 14 | ||||||
| Mean (SD) before strip application | 1.58 (0.61) | 1.40 (0.60) | 1.61 (0.70) | 43.84 (22.32) | 40.90 (24.73) | 45.78 (23.99) |
| Mean (SD) after strip application | 1.35 (0.79) | 0.85 (0.88) | 1.06 (0.88) | 53.21 (25.94) | 68 (25.51) | 69.56 (24.12) |
| LS mean change after vs before strip application (95% CI); P value | − 0.09 (− 0.45 to 0.27); P = 0.6129 | − 0.50 (− 0.83 to − 0.17); P = 0.0036 | − 0.45 (− 0.80 to − 0.09); P = 0.0142 | 5.44 (− 4.86 to 15.74); P = 0.2942 | 21.47 (11.33 to 31.60); P < 0.0001 | 20.10 (9.36 to 30.85); P = 0.0004 |
| P value for comparison with placebo | – | P = 0.0786 | P = 0.1356 | – | P = 0.0230c | P = 0.0417c |
| P value for comparison with BRNS | – | – | P = 0.8063 | – | – | P = 0.8451 |
BRNS Breathe Right Nasal Strip, CI confidence interval, ITT intent-to-treat, LS least square, SD standard deviation, VAS visual analog scale
a Subjects rated how stuffed their noses felt on a scale of 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms
b VAS scale of 0 = nose is extremely blocked to 100 = nose is extremely clear
c Significant difference between treatments