Table 2.
Schedule of participants enrollment and baseline assessment, 2017-2018.
| 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.