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. 2012 Feb 2;13(1):12. doi: 10.1186/1465-9921-13-12

Table 1.

Demographic and baseline clinical phenotypes in COPD and control populations

Parameter T54 COPDa BioServe COPDb Healthy controlsc p (COPD vs healthy control)d
Total Placebo 3 mg/kg 5 mg/kg p-value Total p (vs T54) Ctr1 Ctr2 Ctr1 vs T54, BS Ctr2 vs T54, BS
Sample size (n) 234e 68 64 68 160 50 109
Gender(n: male/female) 140/94 43/25 40/24 37/31 0.51 73/87 0.37 30/20 54/42 (1.0, 0.52) (0.27, 0.63)
Age (years) 65.2 ± 8.8 65.0 ± 8.9 64.4 ± 8.2 64.9 ± 9.6 0.93 65.8 ± 11.8 0.57 38.7 ± 11.8 49.9 ± 14.5 (< 10-4, < 10-4) (< 10-4, < 10-4)
BMI (kg/m2) 27.2 ± 6.1 28.2 ± 6.1 26.6 ± 5.4 27.0 ± 6.6 0.32 26.5 ± 7.0 0.27 27.0 ± 6.8 27.9 ± 6.9 (0.82, 0.65) (0.46, 0.16)
Race (n) 0.46 0.036 (< 10-4, < 10-4) (< 10-4, < 10-4)
Black 10 3 1 4 14 25 41
Caucasian 223 64 63 64 143 5 22
Other 1 1 0 0 3 20 12
Smoking status (n) 0.93 0.00011 (< 10-4, < 10-4) (< 10-4, < 10-4)
Current smoker 104 29 29 31 50 33 36
Ex-smoker 130 39 35 37 100
Non-smoker 9 16 24
GOLD stage (n) 0.66 < 10-9 n/a n/a n/a n/a
stage I 3 1 0 2 40
stage II 74 23 21 20 40
stage III 104 33 31 26 40
stage IV 53 11 16 16 40
Subtype (n) 0.58 < 10-9 n/a n/a n/a n/a
Chronic bronchitis 54 20 11 15 41
Chronic emphysema 95 26 28 28 80
Both 85 22 25 25 3
FEV1 (% predicted)
Baseline 43.4 ± 16.0 45.2 ± 16.2 43.9 ± 17.5 41.8 ± 14.9 0.49 52.7 ± 25.1 0.000051 n/a n/a n/a n/a
Change from baseline -1.1 ± 6.7 -1.4 ± 7.5 0.3 ± 6.1 -1.9 ± 7.5 0.19 n/a n/a n/a n/a n/a n/a
CRQ total score
Baseline 80.4 ± 19.1 83.8 ± 20.1 77.1 ± 17.5 80.2 ± 19.3 0.11 n/a n/a n/a n/a n/a n/a
Change from baseline 10.3 ± 18.6 12.3 ± 19.2 12.7 ± 22.7 15.1 ± 10.0 0.70 n/a n/a n/a n/a n/a n/a

aClinical and demographic information for the C0168T54 COPD population is presented for all patients with baseline serum analyses performed (total) and stratified by treatment group (placebo, 3 mg/kg infliximab, or 5 mg/kg infliximab) for patients who had serum samples analyzed for both baseline and week 24 timepoints (n = 200). P-values are presented for significance of differences among the treatment groups.

bClinical and demographic information for the BioServe COPD population, with p-values presented for significance of differences between BioServe and T54 COPD populations.

cClinical and demographic information for the healthy control populations. Ctr1, control population samples bioanalyzed in same batch as COPD samples; Ctr2, control population samples bioanalyzed independently of the COPD and Ctr1 samples.

dP-values for the significance of differences between the indicated control population vs COPD population (T54, BioServe).

eSummary statistics are sample size (n), mean ± standard deviation, or p-value.

BMI, body mass index; COPD, chronic obstructive pulmonary disease; CRQ, chronic respiratory questionnaire; FEV1, forced expiratory volume in 1 second; GOLD, Global Initiative for Chronic Obstructive Lung Disease; n/a, not applicable.