In physiologically adjusted P15 lung density (g/L) at TLC more than 48 months. Notes: Slopes estimated according to data acquired from early-Start (N=75) and Delayed-Start (N=64) subjects who had completed both RAPID-RCT and RAPID-OLe trials. Reproduced from the Lancet Respiratory Medicine, Vol 5. McElvaney NG, et al. Long-term efficacy and security of 1 proteinase inhibitor treatment for emphysema brought on by extreme 1 antitrypsin deficiency: an open-label extension trial (RAPID-OLE), pp. 510. Copyright (2017), with permission from Elsevier.22 Abbreviations: AAT, alpha 1 antitrypsin; adjusted P15, lung volume-adjusted 15th percentile in the lung density; OLe, open-label extension; Speedy, Randomized, Placebocontrolled Trial of Augmentation Therapy in Alpha-1 Proteinase Inhibitor Deficiency; RCT, randomized controlled trial; TLC, total lung capacity.International Journal of COPD 2018:submit your manuscript | www.dovepress.comDovepressTable 1 Traits of clinical trials and observational studies employing CT densitometric indices as outcome measures for emphysema progressionObservational studiesDirksen et al21Randomized controlled trials Chapman et al 2015 Prospective, randomized, parallel, double-blind, placebocontrolled trial 180 N/A N/A N/A 140 45 256 22 119 N/A 2017 Potential, randomized, parallel, double-blind, activecontrolled trial 2001 Potential, single-center, observational study 2003 Potential, singlecenter, observational study 2003 Potential, single-center, observational study McElvaney et al Dowson et al31 Dawkins et al32 Stolk et al33 Parr et alChapman et alDirksen et alDovepressYear Study design1999 Potential, randomized, parallel, double-blind, placebo-controlled trial at two centers2004 Single-center, observational studysubmit your manuscript | www.dovepress.comNumber of patients Drug dosage and regimen2009 Prospective, randomized, parallel, double-blind, placebo-controlled trial at 3 centersAAT formulation (LFB) 250 mg/kg administered at 4-week intervalsComparatorPlacebo (albumin 625 mg/kg) administered at 4-week intervals Transform in TLC adjusted 15th percentile lung density and regional lung density Lung voxels with density significantly less than -910 HU in upper and reduced respiratory zones at TLCAlpha 1 proteinase inhibitor (ProlastinC) 60 mg/kg weekly infusions Placebo (2 albumin) N/A N/AAlpha 1 proteinase inhibitor (Zemaira Respreeza 60 mg/kg weekly infusions PlaceboN/AN/ARecorded CT parameter and level of inspiration15th percentile lung density from complete lung measures, with tidal breathing for the duration of scan acquisition and at 75 of TLC for Danish and Dutch patients, respectively Change in 15th percentile lung densityAlpha 1 proteinase inhibitor (Zemaira/ Respreeza) 60 mg/kg weekly infusions Alpha 1 proteinase inhibitor (Zemaira/ Respreeza) early intervention group Alter in annual price of adjusted 15th percentile lung density and regional volumeadjusted 15th percentile lung density.TL1A/TNFSF15 Protein MedChemExpress Recorded at TLC, FRC and TLC + FRC combined Lung voxels with density significantly less than -910 HU in upper and reduced respiratory zones at TLC Imply price of Fev1 decline Causes of mortalityRelative location below -950 HU and 15th percentile lung density at TLCwhole lung measures of 15th percentile density and in basal and apical lung regions taken at TLCPrimary outcomesDaily PASSChange in annual rate of adjusted 15th percentile lung density and regional volume-adjusted 15th percentile lung density.CD79B Protein Purity & Documentation Recorded at TLC, FRC and TLC + FRC combined Annual rate of decrease in.PMID:24318587
