Table 2.
Test | Screeninga | Baseline visitb |
Informed consent process | X |
|
Review inclusion/exclusion criteria to determine study eligibility, including smoking status and iQOS use | X |
|
Review medical history | X |
|
Provide study requirements handout (explain study/visit requirements) | X |
|
Pregnancy test | X | X |
Stanford 25 comprehensive clinical assessment |
|
X |
Spirometry (FVCc, FEVd, FEV1e, FEV1/ FVC, FEFf 25-75, MEFg), bronchodilation test using salbutamol |
|
X |
CATh |
|
X |
6MWTi |
|
X |
Short form-12 Quality of Life questionnaire |
|
X |
ECGj |
|
X |
Body mass index |
|
X |
Smoking status and exposures |
|
X |
Comprehensive physical assessment Stanford 25 |
|
X |
Previous COPDk exacerbations based on use of inhaled steroids, antibiotics, inhaled bronchodilators, steroids |
|
X |
Previous COPD exacerbations based on health care visits (office visits, admissions to emergency department or hospital) |
|
X |
Previous COPD severe exacerbations based on emergency department admission or hospitalizations |
|
X |
Laboratory testing for blood cholesterol level, CBCl (25 parameters); HDLm, LDLn, triglycerides, C-reactive protein, fibrinogen, glucose, glycosylated hemoglobin |
|
X |
Biomarker testing for sRAGEo, ICAM1p, and CCL20q |
|
X |
Lung computer tomography |
|
X |
aMonths –3 to 3.
bMonths 0 to 3.
cFVC: forced vital capacity.
dFEV: forced expiratory volume.
eFEV1: forced expiratory volume in 1 second.
fFEF: forced expiratory flow.
gMEF: maximum expiratory flow.
hCAT: COPD Assessment Test.
i6MWT: 6-Minute Walk Test.
jECG: electrocardiogram.
kCOPD: chronic obstructive pulmonary disease.
lCBC: complete blood count.
mHDL: high-density lipoproteins.
nLDL: low-density lipoproteins.
osRAGE:advanced glycosylation end-product receptor.
pICAM1: intercellular adhesion molecule 1.
qCCL20: macrophage inhibitory protein 3a.