Table 1.
Baseline characteristics of TORCH participants with GLI-based moderate-to-severe COPD (N=5688)
| Characteristic | All (N=5688) |
Placebo (N=1413) |
Salmeterol (N=1418) |
Fluticasone (N=1427) |
Combination * (N=1430) |
P value† |
|---|---|---|---|---|---|---|
| Mean ± SD or No. (Column %) | ||||||
| Age, years | 64.8 ±8.3 | 64.8 ±8.2 | 64.8 ±8.2 | 64.8 ±8.5 | 64.8 ±8.3 | 0.997 |
| Aged ≥60 years | 4210 (74.0) | 1040 (73.6) | 1068 (75.3) | 1051 (73.6) | 1051 (73.5) | 0.643 |
| Height, meters | 1.7 ±0.1 | 1.7 ±0.1 | 1.7 ±0.1 | 1.7 ±0.1 | 1.7 ±0.1 | 0.417 |
| Male sex | 4303 (75.6) | 1069 (75.6) | 1087 (76.7) | 1078 (75.5) | 1069 (74.8) | 0.703 |
| BMI | 25.2 ±5.1 | 25.3 ±5.1 | 25.2 ±5.1 | 25.1 ±5.0 | 25.2 ±5.3 | 0.905 |
| Race/Ethnicity | ||||||
| White‡ | 4622 (81.3) | 1151 (81.5) | 1154 (81.4) | 1154 (80.9) | 1163 (81.3) | 0.999 |
| American Hispanic§ | 179 (3.1) | 46 (3.3) | 42 (3.0) | 45 (3.1) | 46 (3.2) | |
| African-American¶ | 82 (1.4) | 21 (1.5) | 18 (1.3) | 21 (1.5) | 22 (1.5) | |
| Asian ** | 756 (13.3) | 185 (13.1) | 190 (13.4) | 194 (13.6) | 187 (13.1) | |
| Other†† | 49 (0.9) | 10 (0.7) | 14 (1.0) | 13 (0.9) | 12 (0.8) | |
| Smoking history | ||||||
| Current smokers | 2465 (43.3) | 613 (43.4) | 610 (43.0) | 621 (43.5) | 621 (43.4) | 0.994 |
| Former smokers | 3223 (56.7) | 800 (56.6) | 808 (57.0) | 806 (56.5) | 809 (56.6) | |
| Pack-years‡‡ | 48.5 ±27.4 | 48.7 ±27.0 | 49.3 ±27.8 | 49.1 ±28.4 | 47.1 ±26.2 | 0.217 |
| Respiratory Phenotypes | ||||||
| MMRC dyspnea grade ≥ 2§§ | 2855 (50.2) | 700 (49.6) | 707 (49.9) | 734 (51.5) | 714 (49.9) | 0.719 |
| Prior COPD exacerbation¶¶ | 0.2 ±0.6 | 0.2 ±0.7 | 0.2 ±0.6 | 0.3 ±0.6 | 0.2 ±0.6 | 0.610 |
| Spirometry | ||||||
| Pre-BD FEVi/FVC ratio | 0.47 ±0.10 | 0.47 ±0.10 | 0.47 ±0.10 | 0.47 ±0.10 | 0.47 ±0.10 | 0.792 |
| Pre-BD FEVi in liters | 1.10 ±0.39 | 1.10 ±0.39 | 1.09 ±0.39 | 1.10 ±0.39 | 1.10 ±0.40 | 0.913 |
| Pre-BD FVC in liters | 2.35 ±0.76 | 2.37 ±0.75 | 2.32 ±0.73 | 2.37 ±0.79 | 2.35 ±0.76 | 0.575 |
| BD reversibility *** | 2302 (40.5) | 561 (39.7) | 589 (41.5) | 557 (39.1) | 595 (41.6) | 0.398 |
| GLI airflow-obstruction††† | ||||||
| Moderate-to-severe | 5688 (100) | 1413 (100) | 1418 (100) | 1427 (100) | 1430 (100) | ------ |
| Moderate | 212 (3.7) | 47 (3.3) | 51 (3.6) | 61 (4.3) | 53 (3.7) | 0.595 |
| Severe | 5476 (96.3) | 1366 (96.7) | 1367 (96.4) | 1366 (95.7) | 1377 (96.3) | |
Abbreviations: BD, bronchodilator; BMI, body mass index; COPD, chronic obstructive pulmonary disease; GLI, Global Lung Function Initiative; MMRC, Modified Medical Research Council; TORCH Study, Towards a Revolution in COPD Health Study.
The combination group includes salmeterol plus fluticasone.
Comparisons were across treatment and placebo groups. Pearson chi-square tests were used for categorical outcomes and Kruskal-Wallis tests were used for continuous outcomes.
Defined by TORCH as having origins in the original peoples of Europe, Middle East, Western Russia, Afghanistan, or white racial groups of Africa.
Defined by TORCH as Hispanics of North, Central, or South American origin.
Defined by TORCH as having origins in any of the black racial groups of Africa.
Defined by TORCH as having origins in the original peoples of the Indian subcontinent, Far East, Southeast Asia, or Pacific Islands.
Defined by TORCH as other racial group that is not represented above, or whose predominant origin cannot be determined.
Calculated as average pack-years for the combined group of current and former smokers.
Grade ranges from 0–4. Missing data in 5 participants.
Number of self-reported exacerbations of COPD that required hospitalization in the year prior to study entry.
Change in FEV1, calculated as [(Post BD – pre-BD) / pre-BD FEV1] x 100%. BD reversibility was defined by ATS-ERS criteria, specifically as an increase in the post-BD FEV1 of >12% and ≥200 mL. Missing data in 1 participant.
In the TORCH trial, airflow-obstruction confirmed a diagnosis of COPD. Using GLI reference equations, a combined diagnosis of moderate-to-severe airflow-obstruction (COPD) was established by Z-scores for FEV1/FVC and FEV1, both < −1.64. The distinction between moderate and severe airflow-obstruction (COPD) was further stratified by Z-scores for FEV1 of < −1.64 but ≥ −2.55 as moderate disease and of < −2.55 for severe disease. The Z-score of −1.64 defined the 5th percentile of distribution (lower limit of normal), while the Z-score of −2.55 defined the 0.5th percentile of distribution.