Table 2. Sample-size estimates based on zero Cl− plus isoproterenol (CFTR) response*.
Treatment Effect (mV) | Total Number of Subjects | |||||
90% Power | 80% Power | |||||
Average of Both Nostrils | Most-polarized nostril at Each Visit | Most-polarized nostril at Screening Carried Forward | Average of Both Nostrils | Most-polarized nostril at Each Visit | Most-polarized nostril at Screening Carried Forward | |
A. Comparison with placebo | ||||||
−1 | 854 | 676 | 854 | 638 | 506 | 638 |
−2 | 216 | 172 | 216 | 162 | 128 | 162 |
−3 | 98 | 78 | 98 | 74 | 58 | 74 |
−4 | 56 | 46 | 56 | 42 | 34 | 42 |
−5 | 38 | 30 | 38 | 28 | 24 | 28 |
B. Within-group comparison ** | ||||||
−1 | 215 | 188 | 215 | 161 | 149 | 161 |
−2 | 56 | 49 | 56 | 42 | 37 | 42 |
−3 | 26 | 23 | 26 | 20 | 18 | 20 |
−4 | 16 | 14 | 16 | 12 | 11 | 12 |
−5 | 11 | 10 | 11 | 9 | 8 | 9 |
Parts 1 and 2 combined analysis at Day 14.
Assume a single-arm study.