Table 2.
Change in Dyspnea, Walk Distance and Fatigue Between with Fentanyl Pectin Nasal Spray and Placeboa
| Baseline walk test |
Second walk test |
Difference between first walk test and second walk test |
Third walk test |
Difference between first walk test and third walk test |
|
|---|---|---|---|---|---|
| Variable | Mean (SD) | Mean (SD) | Mean change (95% CI)a |
Mean (SD) |
Mean change (95% CI)a |
|
Dyspnea numeric rating scale |
|||||
| Placebo: at time of study drug admin |
- | 2.0 (1.2) | - | 1.6 (1.4) | - |
| FPNS: at time of study drug admin |
- | 3.3 (1.4) | - | 2.0 (1.9) | - |
| Placebo: 0 minutes | 1.7 (1.2) | 1.2 (1.4) | −0.5 (−1.3, 0.3) |
1.1 (1.3) | −0.5 (−1.4, 0.3) |
| FPNS: 0 minutesb | 2.4 (1.7) | 1.5 (1.8) | −0.9 (−1.7,− 0.1) |
1.2 (1.7) | −1.3 (−2.0, −0.5) |
| Placebo: 6 minutes | 5.4 (2.0) | 3.8 (2.7) | −1.7 (−3.3,− 0.1) |
2.8 (2.5) | −2.5 (−4.2, −0.9) |
| FPNS: 6 minutes | 6.2 (1.9) | 4.1 (2.6) | −2.0 (−3.5,− 0.6) |
3.8 (2.6) | −2.3 (−4.0, −0.7) |
| Walk distance at 6 minutes | |||||
| Placebo: 6 minutes | 371.2 (114.2) |
387.5 (111.3) | 16.3 (−8.6, 41.3) |
391.3 (112.1) |
14.6 (−11.0, 40.3) |
| FPNS: 6 minutes | 321.8 (80.6) |
345.5 (79.7) |
23.8 (1.3, 46.2) |
345.0 (80.5) |
23.3 (−1.7, 48.2) |
| Dyspnea Borg Scale | |||||
| Placebo: 0 minutes | 1.3 (1.0) | 0.8 (1.2) | −0.4 (− 1.0,0.1) |
1.0 (1.3) | −0.2 (−0.9,0.5) |
| FPNS: 0 minutesb | 2.0 (1.3) | 1.2 (1.5) | −0.8 (−1.6,− 0.1) |
1.0 (1.6) | −1.0 (−1.9,−0.2) |
| Placebo: 6 minutes | 4.4 (1.8) | 2.7 (2.5) | −1.7 (−3.3,− 0.1) |
2.3 (2.2) | −2.4 (−4.2,−0.6) |
| FPNS: 6 minutes | 5.0 (2.0) | 3.3 (2.3) | −1.8 (−3.1,− 0.4) |
3.1 (2.9) | −1.7 (−3.5,0) |
| Fatigue Borg Scale | |||||
| Placebo: 0 minutes | 1.5 (1.1) | 1.5 (1.4) | 0 (−0.8, 0.8) | 1.4 (1.8) | −0.1 (−1.3, 1.1) |
| FPNS: 0 minutesb | 3.0 (1.0) | 2.0 (1.8) | −1.0 (−1.9,− 0.1) |
2.6 (1.9) | −0.5 (−1.6, 0.7) |
| Placebo: 6 minutes | 3.4 (2.9) | 2.9 (2.7) | −0.5 (−1.6, 0.7) |
2.3 (2.1) | −0.9 (−2.3, 0.5) |
| FPNS: 6 minutes | 3.7 (2.5) | 3.2 (2.4) | −0.5 (−1.7, 0.8) |
2.8 (2.4) | −0.7 (−2.1, 0.6) |
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, 15 minutes after fentanyl/placebo administration (i.e. dyspnea at rest)