A: FeNO change from baseline and FF/VI:placebo ratio following onset of treatment | |||||||
Day of treatment | Time point | Geometric LSmean | Ratio (FF/VI vs Placebo) | 95% CI of the Ratio | |||
n | FF/VI 100/25 mcg | n | Placebo | ||||
1 | PM | 25 | 0.97 | 26 | 0.90 | 1.09 | (0.91,1.29) |
2 | AM | 27 | 0.91 | 27 | 1.00 | 0.91 | (0.77,1.07) |
PM | 27 | 0.81 | 25 | 0.89 | 0.91 | (0.77,1.08) | |
3 | AM | 27 | 0.75 | 27 | 0.95 | 0.79 | (0.67,0.94) |
PM | 27 | 0.64 | 25 | 0.88 | 0.72 | (0.61,0.86) | |
4 | AM | 26 | 0.52 | 27 | 0.90 | 0.58 | (0.49,0.69) |
PM | 27 | 0.48 | 27 | 0.89 | 0.54 | (0.46,0.64) | |
5 | AM | 27 | 0.46 | 27 | 0.99 | 0.47 | (0.39,0.55) |
PM | 26 | 0.45 | 26 | 0.95 | 0.47 | (0.40,0.56) | |
6 | AM | 26 | 0.45 | 27 | 0.97 | 0.46 | (0.39,0.55) |
PM | 27 | 0.41 | 27 | 0.96 | 0.42 | (0.36,0.50) | |
7 | AM | 27 | 0.45 | 26 | 0.96 | 0.47 | (0.39,0.56) |
PM | 27 | 0.39 | 27 | 0.88 | 0.45 | (0.38,0.53) | |
8 | AM | 27 | 0.40 | 27 | 0.94 | 0.43 | (0.37,0.51) |
PM | 27 | 0.37 | 26 | 0.90 | 0.41 | (0.34,0.48) | |
9 | AM | 26 | 0.39 | 27 | 0.99 | 0.40 | (0.33,0.47) |
PM | 25 | 0.34 | 25 | 0.89 | 0.38 | (0.32,0.46) | |
10 | AM | 26 | 0.36 | 26 | 0.93 | 0.39 | (0.33,0.46) |
PM | 27 | 0.36 | 26 | 0.90 | 0.40 | (0.34,0.47) | |
11 | AM | 27 | 0.33 | 27 | 0.92 | 0.36 | (0.30,0.42) |
PM | 27 | 0.31 | 27 | 0.88 | 0.36 | (0.30,0.42) | |
12 | AM | 27 | 0.39 | 27 | 0.94 | 0.42 | (0.35,0.49) |
PM | 27 | 0.35 | 27 | 0.91 | 0.39 | (0.33,0.46) | |
13 | AM | 24 | 0.34 | 25 | 0.99 | 0.35 | (0.29,0.41) |
PM | 24 | 0.32 | 25 | 0.94 | 0.34 | (0.29,0.40) | |
14 | AM | 23 | 0.38 | 23 | 1.00 | 0.37 | (0.32,0.44) |
PM | 23 | 0.32 | 22 | 1.00 | 0.32 | (0.27,0.37) | |
B: FeNO change from baseline and FF/VI:placebo ratio following cessation of treatment | |||||||
Day relative to last dose | Time point | Geometric LSmean | Ratio (FF/VI vs Placebo) | 95% CI of the Ratio | |||
n | FF/VI 100/25 mcg | n | Placebo | ||||
1 | AM | 27 | 0.38 | 27 | 1.03 | 0.36 | (0.31,0.43) |
PM | 27 | 0.32 | 27 | 0.98 | 0.33 | (0.28, 0.39) | |
2 | AM | 27 | 0.38 | 27 | 0.99 | 0.38 | (0.32, 0.45) |
PM | 27 | 0.35 | 27 | 0.94 | 0.37 | (0.31, 0.44) | |
3 | AM | 27 | 0.45 | 27 | 0.98 | 0.46 | (0.39, 0.54) |
PM | 27 | 0.42 | 27 | 0.91 | 0.47 | (0.40, 0.56) | |
4 | AM | 27 | 0.55 | 27 | 0.98 | 0.56 | (0.47, 0.66) |
PM | 27 | 0.49 | 27 | 0.85 | 0.58 | (0.49, 0.69) | |
5 | AM | 27 | 0.52 | 27 | 0.83 | 0.63 | (0.53, 0.75) |
PM | 26 | 0.48 | 26 | 0.72 | 0.67 | (0.57, 0.80) | |
6 | AM | 26 | 0.53 | 26 | 0.79 | 0.67 | (0.56, 0.80) |
PM | 26 | 0.48 | 24 | 0.78 | 0.62 | (0.52, 0.74) | |
7 | AM | 27 | 0.49 | 27 | 0.82 | 0.60 | (0.51, 0.71) |
PM | 25 | 0.49 | 25 | 0.79 | 0.62 | (0.52, 0.74) | |
8 | AM | 27 | 0.56 | 25 | 0.82 | 0.69 | (0.58, 0.81) |
PM | 26 | 0.56 | 27 | 0.82 | 0.68 | (0.57, 0.80) | |
9 | AM | 27 | 0.61 | 27 | 0.92 | 0.66 | (0.56, 0.78) |
PM | 27 | 0.62 | 27 | 0.91 | 0.68 | (0.57, 0.80) | |
10 | AM | 26 | 0.66 | 24 | 1.01 | 0.66 | (0.55, 0.78) |
PM | 27 | 0.67 | 27 | 0.98 | 0.68 | (0.58, 0.81) | |
11 | AM | 26 | 0.77 | 26 | 1.06 | 0.73 | (0.61, 0.86) |
PM | 27 | 0.74 | 27 | 1.01 | 0.73 | (0.61, 0.86) | |
12 | AM | 27 | 0.73 | 27 | 1.01 | 0.72 | (0.61, 0.85) |
PM | 27 | 0.70 | 27 | 0.99 | 0.71 | (0.60, 0.84) | |
13 | AM | 25 | 0.76 | 27 | 1.05 | 0.72 | (0.61, 0.86) |
PM | 25 | 0.74 | 25 | 0.95 | 0.78 | (0.66, 0.93) | |
14 | AM | 27 | 0.79 | 26 | 1.00 | 0.79 | (0.66, 0.93) |
PM | 26 | 0.63 | 25 | 0.95 | 0.67 | (0.56, 0.79) | |
15 | AM | 26 | 0.76 | 26 | 0.97 | 0.79 | (0.66, 0.93) |
PM | 25 | 0.73 | 25 | 0.92 | 0.79 | (0.66, 0.94) | |
16 | AM | 27 | 0.75 | 26 | 1.01 | 0.74 | (0.62, 0.87) |
PM | 27 | 0.73 | 26 | 1.01 | 0.73 | (0.61, 0.86) | |
17 | AM | 26 | 0.79 | 25 | 1.03 | 0.77 | (0.65, 0.91) |
PM | 16 | 0.79 | 18 | 0.97 | 0.81 | (0.65, 1.01) | |
18 | AM | 14 | 0.75 | 17 | 0.98 | 0.77 | (0.61, 0.96) |
PM | 10 | 0.67 | 14 | 0.87 | 0.77 | (0.59, 1.00) | |
19 | AM | 10 | 0.78 | 14 | 0.96 | 0.81 | (0.63, 1.05) |
PM | 6 | 0.67 | 12 | 0.93 | 0.72 | (0.52, 1.00) | |
20 | AM | 6 | 0.77 | 12 | 0.99 | 0.78 | (0.56, 1.09) |
PM | 5 | 0.72 | 7 | 0.92 | 0.78 | (0.53, 1.14) | |
21 | AM | 6 | 0.85 | 7 | 1.00 | 0.85 | (0.59, 1.22) |
PM | 5 | 0.75 | 7 | 0.99 | 0.75 | (0.50, 1.13) |