Background
Methods
Within medication group analysis
Head-to-head analysis
Results
Baseline characteristics
All COPD subjects | Chronic oral steroids | TIO/LABA/ICS | TIO | ICS ± LABA | SAB | |
---|---|---|---|---|---|---|
N = | 3828 | 174 | 863 | 256 | 628 | 366 |
Gender (female) | 2091 (52 %) | 87 (50 %) | 447 (52 %) | 120 (47 %) | 305 (49 %) | 218 (60 %) |
Race (African-American) | 736 (19 %) | 50 (29 %) | 155 (18 %) | 35 (14 %) | 112 (18 %) | 92 (25 %) |
Oxygen Therapy | 948 (36 %) | 87 (50 %) | 455 (53 %) | 71 (28 %) | 165 (26 %) | 57 (16 %) |
Chronic Bronchitis | 968 (30 %) | 52 (30 %) | 242 (28 %) | 65 (25 %) | 186 (30 %) | 128 (35 %) |
Doctor's Diagnosis of Asthma | 918 (32 %) | 71 (41 %) | 271 (31 %) | 41 (16 %) | 247 (39 %) | 107 (29 %) |
Frequent Cough Symptom | 1597 (47 %) | 87 (50 %) | 369 (43 %) | 118 (46 %) | 289 (46 %) | 204 (56 %) |
Frequent Phlegm Symptom | 1739 (52 %) | 107 (61 %) | 420 (49 %) | 115 (45 %) | 328 (52 %) | 209 (57 %) |
Hay Fever | 1156 (33 %) | 69 (40 %) | 263 (30 %) | 79 (31 %) | 235 (37 %) | 113 (31 %) |
GERD | 1142 (34 %) | 54 (31 %) | 313 (36 %) | 85 (33 %) | 220 (35 %) | 114 (31 %) |
Cardiovascular Disease | 748 (22 %) | 31 (18 %) | 197 (23 %) | 63 (25 %) | 129 (21 %) | 83 (23 %) |
Age (years) | 63.8 ± 8.3 | 63.7 ± 8.6 | 64.5 ± 7.7 | 66.3 ± 8.1 | 64.6 ± 8.5 | 62.5 ± 8.6 |
Pack Years of Smoking | 51.7 ± 28 | 51.5 ± 29 | 54.1 ± 26 | 53.5 ± 28 | 52.8 ± 30 | 54.3 ± 29 |
Current Smoking | 1486 (39 %) | 42 (24 %) | 188 (22 %) | 88 (34 %) | 202 (32 %) | 202 (55 %) |
6MWT distance (ft) | 1250 ± 380 | 943 ± 400 | 1068 ± 350 | 1216 ± 320 | 1206 ± 390 | 1212 ± 370 |
FEV1 percent predicted | 57.2 ± 20 | 39.3 ± 19 | 41.7 ± 17 | 54.4 ± 19 | 53.1 ± 20 | 56.1 ± 19 |
FEV1/FVC | 0.52 ± 0.13 | 0.43 ± 0.12 | 0.43 ± 0.12 | 0.49 ± 0.11 | 0.50 ± 0.13 | 0.53 ± 0.12 |
GOLD 1 | 660 (17 %) | 6 (3 %) | 21 (2 %) | 23 (9 %) | 60 (10 %) | 44 (12 %) |
GOLD 2 | 1634 (43 %) | 37 (21 %) | 238 (28 %) | 120 (47 %) | 275 (44 %) | 174 (47 %) |
GOLD 3 | 1022 (27 %) | 67 (39 %) | 364 (42 %) | 84 (33 %) | 209 (33 %) | 116 (32 %) |
GOLD 4 | 512 (13 %) | 64 (37 %) | 240 (28 %) | 29 (11 %) | 84 (13 %) | 32 (9 %) |
MMRC Score | 1.9 ± 1.3 | 3.0 ± 1.1 | 2.8 ± 1.1 | 2.0 ± 1.2 | 2.3 ± 1.3 | 2.0 ± 1.4 |
SGRQ Total Score | 36.2 ± 19 | 57.2 ± 17 | 49.1 ± 18 | 38.9 ± 17 | 42.6 ± 20 | 41.9 ± 20 |
BODE score | 2.5 ± 1.9 | 4.4 ± 1.9 | 4.0 ± 1.7 | 2.6 ± 1.7 | 2.9 ± 1.9 | 2.6 ± 1.8 |
TLC by CT percent predicted | 102.3 ± 17 | 104.5 ± 17 | 106.1 ± 18 | 101.9 ± 15 | 104.3 ± 17 | 100.4 ± 16 |
SRWA-Pi10 | 3.70 ± 0.14 | 3.76 ± 0.13 | 3.72 ± 0.14 | 3.70 ± 0.14 | 3.73 ± 0.15 | 3.74 ± 0.16 |
Percent Emphysema | 12.0 ± 13 | 18.4 ± 14 | 19.5 ± 14 | 12.7 ± 10 | 12.7 ± 12 | 8.8 ± 9.4 |
Percent Gas Trapping | 36.4 ± 20 | 47.7 ± 20 | 48.7 ± 19 | 39.0 ± 17 | 39.3 ± 20 | 33.8 ± 20 |
BMI (kg/m^2) | 28.0 ± 6.4 | 27.9 ± 6.3 | 27.8 ± 6.3 | 27.8 ± 6.1 | 28.4 ± 6.5 | 28.8 ± 7.1 |
Exacerbations/Year in Follow-Up | 0.7 ± 1.4 | 1.5 ± 2.0 | 1.1 ± 1.7 | 0.5 ± 0.9 | 0.7 ± 1.1 | 0.6 ± 1.1 |
Severe Exacerbations/Year | 0.2 ± 0.8 | 0.6 ± 1.3 | 0.4 ± 0.9 | 0.1 ± 0.3 | 0.2 ± 0.6 | 0.2 ± 0.6 |
TIO | ICS ± LABA |
p-value | |
---|---|---|---|
Gender (female, %) | 46.9 | 48.6 | 0.7 |
Race (Non-Hispanic White, %) | 86.3 | 82.2 | 0.2 |
Oxygen Therapy (%) | 27.7 | 26.3 | 0.7 |
Chronic Bronchitis (%) | 25.4 | 29.6 | 0.2 |
Doctor's Diagnosis of Asthma (%) | 16.0 | 39.3 |
<0.001
|
Frequent Cough Symptom (%) | 46.1 | 46.0 | 1.0 |
Frequent Phlegm Symptom (%) | 44.9 | 52.2 | 0.06 |
Hay Fever (%) | 30.9 | 37.4 | 0.2 |
GERD (%) | 33.2 | 35.0 | 0.7 |
Cardiovascular disease (%) | 24.6 | 20.5 | 0.2 |
Age (years) | 66.3 | 64.6 |
0.006
|
Current Smoking | 34.4 | 32.2 | 0.6 |
Pack-Years of Smoking | 53.5 | 52.8 | 0.7 |
6MWT distance (ft) | 1216 | 1206 | 0.7 |
FEV1 percent predicted | 54.4 | 53.1 | 0.3 |
FEV1/FVC | 0.49 | 0.50 | 0.5 |
MMRC Score | 2.0 | 2.3 |
0.006
|
SGRQ Total Score | 38.9 | 42.6 |
0.007
|
BODE score | 2.6 | 2.9 |
0.02
|
TLC by CT percent predicted | 101.9 | 104.3 |
0.04
|
SRWA-Pi10 | 3.70 | 3.73 |
0.003
|
Percent Emphysema | 12.7 | 12.7 | 1.0 |
Percent Gas Trapping | 39.0 | 39.3 | 0.8 |
BMI (kg/m^2) | 27.8 | 28.4 | 0.2 |
Exacerbations/Year in Follow-Up | 0.5 | 0.7 |
0.004
|
Within medication group analysis
Odds ratio | Lower CI | Upper CI |
p-value | |
---|---|---|---|---|
A. Tiotropium/Inhaled corticosteroid/Long acting beta-agonist | ||||
Age, years | 0.98 | 0.95 | 1.00 | 0.1 |
Female Gender | 1.53 | 1.05 | 2.21 |
0.03
|
African-American Race | 0.69 | 0.44 | 1.09 | 0.1 |
FEV1 Percent Predicted | 1.00 | 0.98 | 1.02 | 0.9 |
TLC by CT percent predicted | 1.01 | 0.99 | 1.02 | 0.3 |
SGRQ Total Score | 1.02 | 1.00 | 1.03 |
0.02
|
MMRC Score | 0.85 | 0.60 | 1.21 | 0.4 |
BODE Score | 1.08 | 0.80 | 1.47 | 0.6 |
Frequent Cough Symptom | 1.11 | 0.75 | 1.64 | 0.6 |
Doctor's Diagnosis of Asthma | 1.19 | 0.98 | 1.45 | 0.08 |
Hay Fever | 1.01 | 0.81 | 1.27 | 0.9 |
Prior Pneumonia | 1.36 | 1.03 | 1.80 |
0.03
|
GERD | 1.62 | 1.11 | 2.38 |
0.01
|
B. Tiotropium | ||||
Age, years | 0.93 | 0.87 | 1.00 |
0.04
|
Female Gender | 2.64 | 0.95 | 7.33 | 0.06 |
African-American Race | 0.15 | 0.02 | 1.28 | 0.08 |
FEV1 percent predicted | 1.02 | 0.99 | 1.06 | 0.1 |
FEV1 change with bronchodilator (L) | 2.99 | 0.10 | 87.43 | 0.5 |
TLC by CT percent predicted | 1.00 | 0.97 | 1.04 | 0.9 |
Percent Gas Trapping | 1.06 | 1.02 | 1.11 |
0.01
|
SGRQ Total Score | 1.01 | 0.98 | 1.04 | 0.4 |
Frequent Cough Symptom | 1.69 | 0.64 | 4.47 | 0.3 |
Doctor's Diagnosis of Asthma | 1.57 | 1.06 | 2.32 |
0.03
|
GERD | 2.75 | 1.10 | 6.88 |
0.03
|
C. Long acting beta-agonist/inhaled corticosteroid | ||||
Age, years | 1.00 | 0.96 | 1.03 | 0.8 |
Female Gender | 1.90 | 1.19 | 3.05 |
0.01
|
African-American Race | 0.71 | 0.39 | 1.29 | 0.3 |
FEV1 percent predicted | 0.98 | 0.96 | 1.01 | 0.1 |
Resting Oxygen Saturation (%) | 0.97 | 0.90 | 1.04 | 0.4 |
6MWT distance | 1.00 | 1.00 | 1.00 | 0.5 |
FEV1 change with bronchodilator (L) | 1.65 | 0.42 | 6.39 | 0.5 |
TLC by CT percent predicted | 1.01 | 0.99 | 1.02 | 0.3 |
Percent Emphysema | 1.02 | 0.99 | 1.04 | 0.2 |
MMRC Score | 1.04 | 0.71 | 1.54 | 0.8 |
SGRQ Total Score | 1.03 | 1.01 | 1.04 |
0.01
|
BODE Score | 0.96 | 0.68 | 1.35 | 0.8 |
Frequent Cough Symptom | 1.50 | 0.91 | 2.45 | 0.1 |
Doctor's Diagnosis of Asthma | 1.00 | 0.77 | 1.29 | 1.0 |
Hay Fever | 1.27 | 0.98 | 1.66 | 0.07 |
Prior pneumonia | 1.35 | 0.99 | 1.84 | 0.06 |
GERD | 1.96 | 1.21 | 3.15 |
0.01
|
Cardiovascular disease | 1.68 | 0.96 | 2.91 | 0.07 |
D. Short acting bronchodilators | ||||
Age, years | 1.01 | 0.97 | 1.05 | 0.8 |
Female Gender | 2.56 | 1.30 | 5.03 |
0.01
|
African-American Race | 0.53 | 0.23 | 1.21 | 0.1 |
FEV1 percent predicted | 0.98 | 0.96 | 1.01 | 0.1 |
Oxygen Therapy | 2.47 | 1.11 | 5.51 |
0.03
|
FEV1 change with bronchodilator (L) | 5.60 | 0.97 | 32.41 | 0.05 |
TLC by CT percent predicted | 1.00 | 0.98 | 1.03 | 0.7 |
Percent Emphysema | 1.03 | 0.99 | 1.08 | 0.2 |
BODE Score | 1.00 | 0.78 | 1.28 | 1.0 |
Frequent Cough Symptom | 2.14 | 1.13 | 4.06 |
0.02
|
Hay Fever | 1.19 | 0.86 | 1.64 | 0.3 |
Prior Pneumonia | 1.08 | 0.75 | 1.56 | 0.7 |
TIO/LABA/ICS | TIO | ICS ± LABA | SAB | |
---|---|---|---|---|
Younger Age (years) | + | |||
Doctor's Diagnosis of Asthma | / | + | ||
Frequent Cough Symptom | + | |||
Female Gender | + | / | + | + |
GERD | + | + | + | |
Oxygen Therapy | + | |||
Higher Percent Gas Trapping | + | |||
Prior Pneumonia | + | / | ||
Higher SGRQ Total Score | + | + |
Head-to-head analysis
Odds ratio | Lower CI | Upper CI |
p-value | |
---|---|---|---|---|
A. All subjects using either TIO or ICS ± LABA (N = 602) | ||||
Tiotropium Usage | 0.69 | 0.45 | 1.06 | 0.09 |
Doctor's Diagnosis of Asthma | 1.22 | 1.01 | 1.47 | 0.04 |
Age (years) | 1.00 | 0.98 | 1.02 | 1.0 |
MMRC Score | 0.97 | 0.75 | 1.25 | 0.8 |
SGRQ Total Score | 1.03 | 1.01 | 1.04 | <0.001 |
BODE Score | 1.08 | 0.92 | 1.26 | 0.4 |
TLC by CT percent predicted | 1.02 | 1.00 | 1.03 | 0.01 |
B. Excluding subjects with doctor diagnosed asthma (N = 341) | ||||
Tiotropium Usage | 0.56 | 0.31 | 1.00 | 0.05 |
Age (years) | 1.00 | 0.96 | 1.03 | 0.9 |
MMRC Score | 1.03 | 0.70 | 1.50 | 0.9 |
SGRQ Total Score | 1.04 | 1.01 | 1.06 | <0.001 |
BODE Score | 0.96 | 0.77 | 1.21 | 0.8 |
TLC by CT percent predicted | 1.02 | 1.00 | 1.04 | 0.02 |
C. Only subjects with doctor diagnosed asthma (N = 198) | ||||
Tiotropium Usage | 1.03 | 0.39 | 2.70 | 1.0 |
Age (years) | 1.01 | 0.97 | 1.05 | 0.6 |
MMRC Score | 0.89 | 0.59 | 1.35 | 0.6 |
SGRQ Total Score | 1.02 | 1.00 | 1.04 | 0.06 |
BODE Score | 1.21 | 0.94 | 1.57 | 0.1 |
TLC by CT percent predicted | 1.01 | 0.99 | 1.03 | 0.2 |