Experience using centralized spirometry in the phase 2 randomized, placebo-controlled, double-blind trial of denufosol in patients with mild to moderate.

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Presentation transcript:

Experience using centralized spirometry in the phase 2 randomized, placebo-controlled, double-blind trial of denufosol in patients with mild to moderate cystic fibrosis C.H. Goss, E.F. McKone, D. Mathews, D. Kerr, J.S. Wanger, S.P. Millard Journal of Cystic Fibrosis Volume 7, Issue 2, Pages 147-153 (March 2008) DOI: 10.1016/j.jcf.2007.07.006 Copyright © 2007 European Cystic Fibrosis Society Terms and Conditions

Fig. 1 Mean absolute value of differences between the over-reading center value and site value for FEV1 (mL) for each subject, plotted by site. Journal of Cystic Fibrosis 2008 7, 147-153DOI: (10.1016/j.jcf.2007.07.006) Copyright © 2007 European Cystic Fibrosis Society Terms and Conditions

Fig. 2 Variability of spirometry as expressed by change in FEV1 (L) from the screening visit to the baseline visit was reduced compared to historical controls but not statistically significant. The difference between individual subjects' FEV1 at screening and at visit 1 prior to dosing was calculated for the denufosol Phase 2 study with and without central over-read, and these differences are compared to differences seen in historical controls. Filled circles represent the mean values and bars represent the 95% confidence intervals. Journal of Cystic Fibrosis 2008 7, 147-153DOI: (10.1016/j.jcf.2007.07.006) Copyright © 2007 European Cystic Fibrosis Society Terms and Conditions

Fig. 3 Differences in variability between the denufosol study and historical studies can possibly be attributed to differences in the duration in days between screening and visit 1 spirometry. The difference between individual subjects' FEV1 at screening and at visit 1 prior to dosing are plotted against the days between screening and visit 1 (○ represents the denufosol study with over-read; ▴ represents historical controls). Slope for denufosol=− 0.008, slope for historical controls=0.006, p=0.03). Journal of Cystic Fibrosis 2008 7, 147-153DOI: (10.1016/j.jcf.2007.07.006) Copyright © 2007 European Cystic Fibrosis Society Terms and Conditions