Efficacy and safety of tiotropium in COPD patients in primary care – the SPiRiva Usual CarE (SPRUCE) study

Respiratory Research

Table 4 Median (interquartile range) for trough FEV₁ and FVC responses (L) on Day 85 according to patients with either FEV₁ ≥50% predicted or FEV₁ <50% predicted (FAS-PFT)

	Trough FEV₁ response (L)^†			Trough FVC response (L)^†
	Tiotropium	Placebo	Effect size ^†	Tiotropium	Placebo	Effect size ^†
FEV ₁ ≥50% predicted (tiotropium n = 86; placebo n = 92)	0.06 (-0.08, 0.23)	0.03 (-0.08, 0.12)	0.04 (-0.03, 0.10)	0.07 (-0.12, 0.22)	-0.01 (-0.18, 0.12)	0.08^‡ (0.00, 0.16)
FEV ₁ <50% predicted (tiotropium n = 105, placebo n = 91)	0.13 (-0.02, 0.30)	0.02 (-0.07, 0.17)	0.07^‡ (0.01, 0.14)	0.17 (-0.05, 0.42)	0.02 (-0.14, 0.18)	0.14^‡ (0.05, 0.24)

* Response is change from baseline
^† Hodges-Lehman shift parameter estimate with 95% CI
^‡ p < 0.05
Definitions of abbreviations: FEV₁ = forced expiratory volume in 1 second; FVC = forced vital capacity; FAS-PFT = Full Analysis Set-pulmonary function tests; CI = confidence interval.

ISSN: 1465-993X