Table 3. Sample-size estimates based on average basal PD (ENaC)*.
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 | ||||||
−5 | 154 | 140 | 226 | 116 | 104 | 170 |
−10 | 40 | 38 | 58 | 32 | 28 | 44 |
−15 | 20 | 18 | 28 | 16 | 14 | 22 |
−20 | 12 | 12 | 18 | 10 | 10 | 14 |
−25 | 10 | 8 | 12 | 8 | 8 | 10 |
B. Within-group comparison ** | ||||||
−5 | 40 | 37 | 58 | 31 | 28 | 44 |
−10 | 12 | 11 | 16 | 10 | 9 | 13 |
−15 | 7 | 7 | 9 | 6 | 6 | 7 |
−20 | 5 | 5 | 6 | 5 | 4 | 5 |
−25 | 4 | 4 | 5 | 4 | 4 | 4 |
Parts 1 and 2 combined analysis at Day 14.
Assume a single-arm study.