Table 2. Change in Dyspnea, Walk Distance and Fatigue Between with Fentanyl Buccal Tablet and Placeboa.
| Variables | Baseline walk test, mean (SD) | Second walk test, mean (SD) | Difference between first and second walk test, mean (95% CI)a | |||
|---|---|---|---|---|---|---|
| Placebo | FBT | Placebo | FBT | Placebo | FBT | |
| Dyspnea numeric rating scale (0-10) | ||||||
| 0 minutesb | 1 (1.2) | 0.9 (1.4) | 1 (0.9) | 0.8 (1) | 0 (-0.7, 0.6) | -0.1 (-0.7, 0.5) |
| 6 minutes | 6 (1.8) | 5.4 (2.1) | 4.8 (2.2) | 2.9 (1.2) | -1.2 (-2.5, 0.1) | -2.6 (-3.9, -1.2) |
| Δ (6-0) minutes | 5 (1.9) | 4.6 (1.7) | 3.9 (2.4) | 2.1 (0.9) | -1.1 (-2.5, 0.2) | -2.4 (-3.5, -1.3) |
| Dyspnea Borg scale (0-10) | ||||||
| 0 minutesb | 1 (1.1) | 0.8 (0.9) | 0.8 (1.4) | 0.7 (0.8) | -0.2 (-0.9, 0.6) | -0.1 (-0.7, 0.6) |
| 6 minutes | 4.5 (1.7) | 4.1 (1.6) | 3.8 (2) | 2.4 (1.2) | -0.7 (-1.9, 0.5) | -1.7 (-2.6, -0.7) |
| Δ (6-0) minutes | 3.5 (1.7) | 3.3 (1.8) | 3 (1.5) | 1.7 (1.3) | -0.5 (-1.9, 0.8) | -1.6 (-2.9, -0.3) |
| Walk distance at 6 minutes (m) | 373.1 (92.5) | 410.9 (80.3) | 379.8 (92.4) | 409.9 (81.8) | 6.7 (-3.4, 16.9) | -1 (-22.3, 20.3) |
| Fatigue Borg Scale | ||||||
| 0 minutesb | 1.8 (1.9) | 1.6 (1.7) | 1.5 (1.6) | 1 (1.1) | -0.3 (-1.2, 0.7) | -0.6 (-2.1, 1) |
| 6 minutes | 4 (2.4) | 3.4 (2.8) | 3.1 (2.5) | 1.3 (1.1) | -0.9 (-2.4, 0.6) | -2.1 (-3.6, -0.6) |
| Δ (6-0) minutes | 2.2 (3.1) | 1.9 (2.8) | 1.6 (2.9) | 0.3 (1) | -0.6 (-2.6, 1.4) | -1.6 (-4, 0.9) |
Abbreviations: CI, confidence interval; FPNS, fentanyl pectin nasal spray; SD, standard deviation
a
Statistically significant values are highlighted in bold
b
The moment just prior to the 6 minute walk test, 30 minutes after FBT/placebo administration (i.e. at rest)