Table 3.
Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire results (ITT population)
| NRQLQ itema | Asymmetric placebo (n = 20) | BRNS clear (n = 20) | Asymmetric butterfly (n = 19) |
|---|---|---|---|
| Sleep problems b | |||
| Mean (SD) at baseline | 15.10 (6.66) | 14.30 (4.57) | 13.63 (5.96) |
| Day 7 | |||
| LS mean change from baseline (95% CI) | − 4.19 (− 6.18 to − 2.21) | − 7.40 (− 9.44 to − 5.36) | − 6.56 (− 8.71 to − 4.42) |
| P value for comparison with placebo | – | P = 0.0221c | P = 0.0942 |
| P value for comparison with BRNS | – | – | P = 0.5462 |
| Day 14 | |||
| LS mean change from baseline (95% CI) | − 5.74 (− 7.74 to − 3.74) | − 7.62 (− 9.68 to − 5.57) | − 7.05 (− 9.21 to − 4.89) |
| P value for comparison with placebo | P = 0.1739 | P = 0.3524 | |
| P value for comparison with BRNS | P = 0.6804 | ||
| Sleep time problems d | |||
| Mean (SD) at baseline | 15.75 (6.99) | 15.45 (5.99) | 15.84 (7.95) |
| Day 7 | |||
| LS mean change from baseline (95% CI) | − 5.64 (− 8.09 to − 3.19) | − 7.49 (− 9.99 to − 5.00) | − 8.21 (− 10.81 to − 5.61) |
| P value for comparison with placebo | – | P = 0.2722 | P = 0.1354 |
| P value for comparison with BRNS | – | – | P = 0.6731 |
| Day 14 | |||
| LS mean change from baseline (95% CI) | − 7.05 (− 9.49 to − 4.61) | − 8.75 (− 11.24 to − 6.26) | − 6.77 (− 9.36 to − 4.18) |
| P value for comparison with placebo | – | P = 0.3136 | P = 0.8677 |
| P value for comparison with BRNS | – | – | P = 0.2463 |
| Symptoms on waking in the morning e | |||
| Mean (SD) at baseline | 16.55 (6.25) | 15.80 (4.42) | 14.74 (4.94) |
| Day 7 | |||
| LS mean change from baseline (95% CI) | − 4.07 (− 6.13 to − 2.02) | − 7.20 (− 9.28 to − 5.11) | − 7.91 (− 10.09 to − 5.72) |
| P value for comparison with placebo | – | P = 0.0298c | P = 0.0099c |
| P value for comparison with BRNS | – | – | P = 0.6195 |
| Day 14 | |||
| LS mean change from baseline (95% CI) | − 5.32 (− 7.33 to − 3.30) | − 7.86 (− 9.90 to − 5.81) | − 8.00 (− 10.14 to − 5.86) |
| P value for comparison with placebo | – | P = 0.0695 | P = 0.0614 |
| P value for comparison with BRNS | – | – | P = 0.9183 |
| Practical problems f | |||
| Mean (SD) at baseline | 7.25 (4.99) | 6.05 (4.36) | 6.53 (5.21) |
| Day 7 | |||
| LS mean change from baseline (95% CI) | − 2.28 (− 3.51 to − 1.04) | − 2.77 (− 4.02 to − 1.52) | − 3.08 (− 4.38 to − 1.78) |
| P value for comparison with placebo | – | P = 0.5564 | P = 0.3500 |
| P value for comparison with BRNS | – | – | P = 0.7211 |
| Day 14 | |||
| LS mean change from baseline (95% CI) | − 3.21 (− 4.34 to − 2.07) | − 3.59 (− 4.74 to − 2.44) | − 3.05 (− 4.25 to − 1.86) |
| P value for comparison with placebo | – | P = 0.6223 | P = 0.8454 |
| P value for comparison with BRNS | – | – | P = 0.4947 |
BRNS Breathe Right Nasal Strip, CI confidence interval, ITT intent-to-treat, LS least square, NRQLQ Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire, SD standard deviation
a Items in individual domains were scored on a 7-point scale where 0 = not troubled, 1 = hardly troubled, 2 = somewhat troubled, 3 = moderately troubled, 4 = quite a bit troubled, 5 = very troubled, and 6 = extremely troubled
b Computed as the sum of sleep problems domain items 1, 2, 3, and 4
c Significant difference between treatments
d Computed as the sum of sleep time problems domain items 5, 6, 7, 8, and 9
e Computed as the sum of waking in the morning domain items 10, 11, 12, and 13
f Computed as the sum of practical problems domain items 14, 15, and 16