TABLE 3.
Placebo | Tiotropium | Difference in change adjusted for period (95% CI ) | p-value | |
Exacerbation duration (days) | 19.6±14.6# | 21.7±16.9# | 2.4 (−1.5–6.2) | 0.49 |
Time to first exacerbation (days) | 104 (80–136)¶ | 74 (50–156)¶ | 1.00 (0.68–1.46)+ | 0.98 |
6MWT (m) | 522±91 | 526±79 | −0.3 (−8.0–7.3) | 0.93 |
SGRQ domain score | ||||
Symptoms | 45.5±232.3 | 46.0±23.1 | 0.7 (−3.5–4.8) | 0.31 |
Activity | 34.7±22.8 | 33.5±20.9 | −0.9 (−3.7–2.0) | 0.54 |
Impacts | 23.1±16.5 | 24.0±16.3 | 0.5 (−2.1–3.0) | 0.72 |
Total | 30.0±17.2 | 30.5±16.4 | 0.3 (−2.0–2.6) | 0.81 |
LCQ domain score | ||||
Physical | 5.21±1.08 | 5.08±1.19 | −0.12 (−0.34–0.10) | 0.28 |
Psychological | 5.34±1.47 | 5.29±1.50 | −0.09 (−0.37–0.18) | 0.50 |
Social | 5.41±1.36 | 5.33±1.41 | −0.12 (−0.37–0.13) | 0.35 |
Total | 16.0±3.8 | 15.7±3.9 | −0.33 (−1.01,0.35) | 0.34 |
CAT score | 14.7±6.9 | 14.6±7.6 | −0.17 (−1.47–1.14) | 0.80 |
Peripheral blood cells | ||||
White blood cells (×109 mL−1) | 8.04±2.53 | 7.65±1.99 | 0.97§ (0.91–1.03) | 0.27 |
Neutrophils (×109 mL−1) | 5.03±2.26 | 4.73±1.72 | 0.97§ (0.89–1.05) | 0.47 |
Eosinophils (×109 mL−1) | 0.247±0.184 | 0.311±0.601 | 1.08§ (0.94–1.24) | 0.30 |
Sputum cells | ||||
Total cells (×109 mL−1) | 21.3±28.8 | 22.9±38.3 | 0.87§ (0.78–0.97) | 0.016 |
Neutrophils (×109 mL−1) | 21.0±28.7 | 22.2±37.6 | 0.90§ (0.62–1.30) | 0.45 |
Eosinophils (×109 mL−1) | 0.15±0.44 | 0.33±1.38 | 0.84ƒ (0.32–2.21) | 0.76¶¶ |
0.83## (0.35–1.95) | ||||
Bronchial epithelial cells (×109 mL−1) | 0.13±0.28 | 0.16±0.27 | 0.92ƒ (0.40–2.16) | 0.87¶¶ |
1.25## (0.74–2.10) |
Data are presented as mean±sd, unless otherwise stated. 6MWT: 6-min walk test; SGRQ: St George's Respiratory Questionnaire; LCQ: Leicester Cough Questionnaire; CAT: COPD Assessment Test. #: sd indicative only, as not all observations independent; ¶: median (95% CI); +: hazard ratio; §: ratio of means; ƒ: odds ratio of value being 0; ##: ratio of means when value >0; ¶¶: overall p-value.