Characteristics of patients at enrolment and after withdrawal of tiotropium#
Placebo | Tiotropium | p-value¶ | |
Subjects n | 126 | 136 | |
At enrolment (Tie-COPD) | |||
Age years | 62.4±8.3 | 62.4±7.4 | 0.98 |
Male | 104 (82.5) | 120 (88.2) | 0.19 |
BMI kg·m−2 | 21.8±3.2 | 22.2±3.4 | 0.35 |
Smoking status | 0.62 | ||
Never-smokers | 28 (22.2) | 27 (19.9) | |
Current smokers | 60 (47.6) | 73 (53.7) | |
Ex-smokers | 38 (30.2) | 36 (26.5) | |
Smoking index pack-years | 48.1±26.7 | 44.7±21.9 | 0.52 |
Duration of COPD days | 179±436 | 125±275 | 0.97 |
Respiratory disease | 2 (1.6) | 4 (2.9) | 0.69 |
Previous respiratory medications | 13 (10.3) | 16 (11.8) | 0.71 |
Baseline before bronchodilator spirometry | |||
FEV1 L | 1.88±0.58 | 1.97±0.55 | 0.22 |
FEV1 % pred | 77.2±19.5 | 77.6±18.3 | 0.89 |
FVC L | 3.17±0.77 | 3.27±0.76 | 0.29 |
FEV1/FVC ratio | 59.0±8.4 | 60.0±7.9 | 0.32 |
Baseline after bronchodilator spirometry | |||
FEV1 L | 2.00±0.55 | 2.11±0.52 | 0.11 |
FEV1 % pred | 82.2±17.9 | 83.0±16.6 | 0.68 |
FVC L | 3.26±0.76 | 3.38±0.72 | 0.18 |
FEV1/FVC ratio | 61.2±7.6 | 62.2±6.9 | 0.25 |
Reversibility+ | 22 (17.5) | 29 (21.3) | 0.43 |
GOLD stage§ | 0.60 | ||
I | 72 (57.1) | 82 (60.3) | |
II | 54 (42.9) | 54 (39.7) | |
CAT scoreƒ | |||
Mean score | 4.0±3.3 | 4.5±4.2 | 0.53 |
Distribution | 0.22 | ||
<10 | 119 (94.4) | 123 (90.4) | |
≥10 | 7 (5.6) | 13 (9.6) | |
mMRC score## | |||
Mean score | 0.60±0.66 | 0.50±0.62 | 0.19 |
Distribution | 0.39 | ||
<2 | 114 (90.5) | 127 (93.4) | |
≥2 | 12 (9.5) | 9 (6.6) | |
CCQ score¶¶ | 0.65±0.53 | 0.66±0.56 | 0.99 |
At follow-up (post-Tie-COPD) | |||
Respiratory medications | 0.35 | ||
Use of respiratory medications | 41 (32.5) | 37 (27.2) | |
No respiratory medications | 85 (67.5) | 99 (72.8) | |
Bronchodilators | 0.54 | ||
Use of bronchodilators | 27 (21.4) | 25 (18.4) | |
No bronchodilators | 99 (78.6) | 111 (81.6) | |
Smoking status | 0.73 | ||
Never-smokers | 28 (22.2) | 25 (18.4) | |
Current smokers | 59 (46.8) | 68 (50.0) | |
Quit smoking | 39 (31.0) | 43 (31.6) |
Data are presented as mean±sd or n (%), unless otherwise stated. Percentages may not sum to 100 because of rounding. Tie COPD: Tiotropium in Early COPD (chronic obstructive pulmonary disease); BMI: body mass index; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; GOLD: Global Initiative for Chronic Obstructive Lung Disease; CAT: COPD Assessment Test; mMRC: modified Medical Research Council; CCQ: Clinical COPD Questionnaire. #: there were no significant between-group differences for characteristics at enrolment. The analysis set included patients who underwent both Tie-COPD and post-Tie-COPD follow-up and had at least one available spirometric data measurement after bronchodilator use at Tie-COPD and at least one measurement at post-Tie-COPD follow-up; ¶: p-values for continuous variables were calculated using t-test or the Wilcoxon rank-sum test, and p-values for categorical variables were calculated using the Chi-squared test; +: defined as an FEV1 value obtained after bronchodilator use that increased by ≥200 mL and by ≥12% from the measurement obtained before bronchodilator use; §: the GOLD staging system is used to assess the severity of lung disease. Stages range from 1 to 4, with higher stages indicating more severe disease. Stage 1 (mild disease) is defined as FEV1 ≥80% of the predicted value, and stage 2 (moderate disease) as FEV1 50–79% pred; ƒ: scores on the CAT range from 0 to 40, with higher scores indicating more severe disease; ##: the mMRC dyspnoea scale ranges from 0 to 4, with higher scores indicating more severe breathlessness; ¶¶: CCQ scores range from 0 to 6, with higher scores indicating worse clinical control.