Skip to main content

Table 3 Median (interquartile range) for trough FEV1 and FVC responses on Day 85 according to LABA, ICS or combination use during the treatment period (FAS-PFT)*

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

 

Trough FEV1 response (L)

Trough FVC response (L)

 

Tiotropium

Placebo

Effect size

Tiotropium

Placebo

Effect size

LABA (tiotropium n = 56; placebo n = 55)

0.05 (-0.07, 0.17)

-0.01 (-0.09, 0.07)

0.07 (0.00, 0.14)

0.05 (-0.12, 0.32)

-0.05 (-0.21, 0.08)

0.12 (0.02, 0.23)

ICS (tiotropium n = 126, placebo n = 113)

0.12 (-0.05, 0.26)

0.00 (-0.09, 0.11)

0.09 (0.04, 0.15)

0.09 (-0.08, 0.35)

-0.01 (-0.17, 0.14)

0.14 (0.06, 0.22)

ICS; no LABA (tiotropium n = 76, placebo n = 65)

0.14 (-0.02, 0.33)

0.02 (-0.08, 0.14)

0.09 (0.01, 0.18)

0.11 (-0.08, 0.43)

0.02 (-0.18, 0.17)

0.14 (0.03, 0.26)

LABA plus ICS (tiotropium n = 50, placebo n = 48)

0.06 (-0.07, 0.19)

-0.02 (-0.09, 0.07)

0.09 (0.01, 0.17)

0.05 (-0.09, 0.34)

-0.04 (-0.18, 0.08)

0.13 (0.02, 0.26)

No LABA; no ICS (tiotropium n = 59, placebo n = 63)

0.09 (-0.02, 0.31)

0.09 (-0.01, 0.27)

0.01 (-0.07, 0.09)

0.13 (-0.06, 0.30)

0.06 (-0.14, 0.21)

0.08 (-0.02, 0.19)

  1. * Numbers of patients for LABA, no ICS were too small for any meaningful comparison (tiotropium group, n = 6; placebo group, n = 7)
  2. Response is change from baseline
  3. Hodges-Lehman shift parameter estimate with 95% CI
  4. Definitions of abbreviations: FEV1 = forced expiratory volume in 1 second; FVC = forced vital capacity; LABA = long-acting β-agonist; ICS = inhaled corticosteroid; FAS-PFT = Full Analysis Set-pulmonary function tests.