4.3.4 Secondary Outcomes 4.3.4.1 Lung Function Rosenthal 1993 data – FEV1% predicted increased in both groups, but was no significant difference between baseline and visit values for either group, or between groups (table 10). The Rosenthal data are the % predicted FEV values as compared to the 1993 Rosenthal data reference ranges. These were the original data collected. The Global Lung Initiative (GLI, 2012) data were calculated later (and shown afterwards). Baseline 3 months 6 months 9 months 12 months Combined mean Mean (SD) Mean Mean Mean Mean Mean (SD) (SD) (SD) (SD) (SD) [95% CI] [95% CI] [95% CI] [95% CI] [95% CI] A 87.0 90.4 89.8 90.9 89.9 91.5 (18.0) (17.7) (17.0) (14.6) (14.3) (14.2) [82.0-91.1] [84.1-96.6] [82.8-96.7] [85.7-96.1] [85.5-94.2] [87.1-95.9] B 83.3 87.1 85.2 86.0 87.3 86.7 (16.4) (13.3) (21.1) (13.8) (16.2) (13.4) [78.4-88.3] [82.4-91.9] [77.7-92.7] [81.1-91.0] [81.8-92.7] [82.6-90.9] A vs. 0.31 0.43 0.38 0.11 0.48 1.27 B P value Table 10 Mean (SD) FEV1% predicted (Rosenthal 1993) scores for each study visit for – groups A and B.
4.3.4 Secondary Outcomes 4.3.4.1 Lung Function – Rosenthal 1993 data FEV1% predicted increased in both groups, but was no significant difference between baseline and visit values for either group, or between groups (table 10). The Rosenthal data are the % predicted FEV values as compared to the 1993 Rosenthal data reference ranges. These were the original data collected. The Global Lung Initiative (GLI, 2012) data were calculated later (and shown afterwards). Baseline Mean (SD) 3 months 6 months 9 months 12 months Combined mean Mean (SD) [95% CI] Mean (SD) [95% CI] Mean (SD) [95% CI] Mean (SD) [95% CI] Mean (SD) [95% CI] A 87.0 (18.0) [82.0-91.1] 90.4 (17.7) [84.1-96.6] 89.8 (17.0) [82.8-96.7] 90.9 (14.6) [85.7-96.1] 89.9 (14.3) [85.5-94.2] 91.5 (14.2) [87.1-95.9] B 83.3 (16.4) [78.4-88.3] 87.1 (13.3) [82.4-91.9] 85.2 (21.1) [77.7-92.7] 86.0 (13.8) [81.1-91.0] 87.3 (16.2) [81.8-92.7] 86.7 (13.4) [82.6-90.9] A vs. B P value 0.31 0.43 0.38 0.11 0.48 1.27 Table 10 – Mean (SD) FEV1% predicted (Rosenthal 1993) scores for each study visit for groups A and B.
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