Table 4. Comparison of NPD and ICM power to detect increasing levels of CFTR function.
| CFTR Measurement | Mean Non-CF response | Mean CF response | Difference (SD) | Percent of non-CF response | Projected Treatment Effect | Estimated Effect Size | Number of Subjects |
|
|---|---|---|---|---|---|---|---|---|
| 80% Power | 90% Power | |||||||
| NPD: | ||||||||
| Zero Cl/Iso (mV) | -22.41 | 1.18 | 23.49 (3.94) | 10 | 2.35 | 0.59 | 19 | 26 |
| 20 | 4.70 | 1.19 | 6 | 8 | ||||
| 30 | 7.05 | 1.79 | 4 | 5 | ||||
| 40 | 9.40 | 2.39 | 3 | 4 | ||||
| 50 | 11.75 | 2.98 | 3 | 3 | ||||
| ICM: | ||||||||
| cAMP (µA/cm2) | -99.50 | -5.00 | 94.50 (12.67) | 10 | 9.45 | 0.75 | 13 | 17 |
| 20 | 18.90 | 1.49 | 5 | 6 | ||||
| 30 | 28.35 | 2.24 | 4 | 4 | ||||
| 40 | 37.80 | 2.98 | 3 | 3 | ||||
| 50 | 47.25 | 3.73 | 3 | 3 | ||||
| CCh (µA/cm2) | -102.20 | 5.90 | 108.10 (10.21) | 10 | 10.81 | 1.06 | 8 | 10 |
| 20 | 21.62 | 2.11 | 4 | 4 | ||||
| 30 | 32.43 | 3.18 | 3 | 3 | ||||
| 40 | 43.24 | 4.24 | 3 | 3 | ||||
| 50 | 54.05 | 5.29 | 3 | 3 | ||||
| 60 | 64.86 | 6.52 | 2 | 3 | ||||
| cAMP + CCh (µA/cm2) | -201.70 | 0.80 | 202.50 (14.66) | 10 | 20.25 | 1.38 | 5 | 7 |
| 20 | 40.50 | 2.76 | 3 | 4 | ||||
| 30 | 60.75 | 4.14 | 3 | 3 | ||||
| 40 | 81.00 | 5.53 | 3 | 3 | ||||
| 50 | 101.25 | 6.91 | 2 | 3 | ||||
Iso, isoproterenol; CCh, carbochol