Table 2.
Week 8a | Week 26 | Week 52 | |||||||
---|---|---|---|---|---|---|---|---|---|
All (N = 59) |
LI (N = 46) |
No LI (N = 13) |
All (N = 61) |
LI (N = 42) |
No LI (N = 19) |
All (N = 62) |
LI (N = 40) |
No LI (N = 22) |
|
% of N | 100.00 | 77.97 | 22.03 | 100.00 | 68.85 | 31.15 | 100.00 | 64.52 | 35.48 |
FVC in l (SD) | 2.79 (0.76) | 2.56 (0.60) | 3.61 (0.70) | 2.91 (0.79) | 2.57 (0.60) | 3.66 (0.62) | 3.05 (0.78) | 2.66 (0.58) | 3.77 (0.55) |
FVC in % of pred. (SD) | 69.00 (15.18) | 63.68 (11.84) | 87.85 (9.75) | 72.00 (15.46) | 64.27 (11.05) | 89.09 (8.41) | 75.46 (14.96) | 67.48 (11.21) | 89.99 (8.62) |
FVC z-score (SD)a | −2.52 (1.30) | −2.96 (1.06) | −0.98 (0.78) | −2.25 (1.24) | − 2.88 (0.88) | − 0.87 (0.66) | −1.99 (1.21) | −2.64 (0.90) | − 0.80 (0.68) |
FEV1 in l (SD) | 2.27 (0.68) | 2.06 (0.54) | 3.01 (0.64) | 2.33 (0.70) | 2.02 (0.52) | 3.01 (0.54) | 2.44 (0.70) | 2.09 (0.52) | 3.07 (0.52) |
FEV1 in % of pred. (SD) | 69.54 (16.64) | 63.54 (12.81) | 90.76 (9.86) | 71.39 (17.72) | 62.60 (13.06) | 90.82 (8.96) | 74.82 (16.63) | 66.28 (12.89) | 90.35 (10.15) |
FEV1 z-score (SD)a | −2.26 (1.28) | −2.71 (1.02) | −0.68 (0.76) | −2.10 (1.27) | − 2.74 (0.90) | − 0.68 (0.67) | −1.85 (1.21) | −2.47 (0.93) | −0.72 (0.74) |
Ratio (FEV1/FVC) | 81.14 (9.74) | 80.66 (10.69) | 82.85 (5.11) | 79.31 (8.69) | 78.01 (9.55) | 82.17 (5.64) | 79.44 (7.95) | 78.50 (9.28) | 81.16 (4.31) |
FEV1/FVC z-score (SD)a | −0.42 (1.59) | −0.49 (1.75) | − 0.17 (0.74) | −0.77 (1.22) | − 0.98 (1.33) | −0.31 (0.79) | − 0.75 (1.28) | −0.92 (1.50) | − 0.46 (0.69) |
avalid spirometry data available only from 59 participants at week 8 and 61 participants at week 26
SD standard deviation, pred predicted, LI lung impairment, % percentage, N number of subjects in (sub-) group
There is a statistical evidence for a difference between the mean FVC at week 8 and week 52, p = 0.046, and no statistical difference between the mean FVC at week 8 and week 26, p = 0.36, and the mean FVC at week 26 and week 52, p = 0.23. There is no statistical difference for mean FEV1 between different study visits: week 8 versus week 26, p = 0.46, week 26 versus week 52, p = 0.34, and week 8 versus week 52, p = 0.12