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Table 2—

Mean PFT values at baseline and the end of the trial

PFTAERx
SC
BaselineEnd of trialBaselineEnd of trial
n 54 50 53 48 
FVC 95.6 ± 12.7 93.9 ± 14.2 97.2 ± 13.7 95.3 ± 14.4 
Change from baseline analysis −2.3 ± 5.7  −2.4 ± 5.8  
 AERx minus SC: 0.19 [−2.0 to 2.43], P = 0.86    
n 54 50 53 48 
FEV1 97.6 ± 13.2 95.1 ± 14.4 96.2 ± 12.2 93.4 ± 13.9 
Change from baseline analysis −3.2 ± 5.7  −3.5 ± 5.8  
 AERx minus SC: 0.36 [−1.9 to 2.62], P = 0.75    
n 54 50 53 48 
FEV1% 104.6 ± 8.6 103.9 ± 9.6 101.1 ± 8.3 100.1 ± 10.0 
Change from baseline analysis −1.1 ± 5.4  −2.1 ± 5.8  
 AERx minus SC: 1.07 [−1.1 to 3.28], P = 0.34    
n 51 49 53 48 
TLC 94.5 ± 13.4 93.4 ± 13.2 96.1 ± 12.9 96.1 ± 13.8 
Change from baseline analysis −1.9 ± 6.0  −0.86 ± 6.0  
 AERx minus SC: −1.08 [−3.5 to 1.30], P = 0.37    
n 53 49 52 48 
DLCO 91.3 ± 16.8 90.8 ± 18.4 93.6 ± 16.7 94.3 ± 16.5 
Change from baseline analysis −2.0 ± 9.1  −1.1 ± 8.9  
 AERx minus SC: −0.97 [−4.5 to 2.52], P = 0.58    
PFTAERx
SC
BaselineEnd of trialBaselineEnd of trial
n 54 50 53 48 
FVC 95.6 ± 12.7 93.9 ± 14.2 97.2 ± 13.7 95.3 ± 14.4 
Change from baseline analysis −2.3 ± 5.7  −2.4 ± 5.8  
 AERx minus SC: 0.19 [−2.0 to 2.43], P = 0.86    
n 54 50 53 48 
FEV1 97.6 ± 13.2 95.1 ± 14.4 96.2 ± 12.2 93.4 ± 13.9 
Change from baseline analysis −3.2 ± 5.7  −3.5 ± 5.8  
 AERx minus SC: 0.36 [−1.9 to 2.62], P = 0.75    
n 54 50 53 48 
FEV1% 104.6 ± 8.6 103.9 ± 9.6 101.1 ± 8.3 100.1 ± 10.0 
Change from baseline analysis −1.1 ± 5.4  −2.1 ± 5.8  
 AERx minus SC: 1.07 [−1.1 to 3.28], P = 0.34    
n 51 49 53 48 
TLC 94.5 ± 13.4 93.4 ± 13.2 96.1 ± 12.9 96.1 ± 13.8 
Change from baseline analysis −1.9 ± 6.0  −0.86 ± 6.0  
 AERx minus SC: −1.08 [−3.5 to 1.30], P = 0.37    
n 53 49 52 48 
DLCO 91.3 ± 16.8 90.8 ± 18.4 93.6 ± 16.7 94.3 ± 16.5 
Change from baseline analysis −2.0 ± 9.1  −1.1 ± 8.9  
 AERx minus SC: −0.97 [−4.5 to 2.52], P = 0.58    

Data are means ± SD unless otherwise indicated. The calculated mean difference of change from baseline after 12 weeks of treatment, the 95% CI, and P values are based on an ANOVA. The PFT values measured were as follows: forced vital capacity (FVC), forced expiratory volume in first second (FEV1), forced expiratory volume in first second/FVC (FEV%), total lung capacity (TLC), and diffusion capacity for carbon monoxide (DLCO). The unit for all these values was percent of predicted normal value.

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